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Chris Preti, CEO of Jubilant HollisterStier Contract Manufacturing Services, shares insight into the outsourcing industry with Grant Playter, associate editor, at the 2023 DCAT Week conference. Topics of discussion include operations and the strategic vision at Jubliant HollsterStier, the current state of contract manufacturing industry, and predictions for the future of the larger outsourcing sector.

A full transcript of the interview can be found below.

Chris, can you introduce yourself for our audience?

: I'm Chris Preti, I'm president of Jubilant HollisterStier Contract Manufacturing Organization.

Can you just tell me a little bit about Jubilant HollisterStier, what you do?

 Jubilant HollisterStier is a mid-size CMO organization and we do everything from clinical trials, materials, to commercial products. Our core capabilities are, or I'd say our sweet spot, is in sterile fill and finish manufacturing as well as a niche ophthalmic market. Specifically, we have over 25 to 30 different companies and we have products in over 40 different countries worldwide through operations in Spokane as well as in Montreal, Canada.

Chris, how would you define your approach as president of the company? What are some key areas that you're planning on focusing on and how, if at all, does it differ for what the company has traditionally operated?

: I think it all starts with what our vision is. Our vision is to be a customer focused, high quality, full service CMO. Customer focused, high quality, full service CMO. I think some elements under that is what that actually means. In the eyes of the customer, we want to make sure that we put them first and foremost. Versus an inside approach, we want to take an outside in approach. The other thing is we want to be known for excellence, excellence in sterile manufacturing, sterile fill finish manufacturing, as well as our ophthalmic niche marketplace.

Can you just talk a little bit about, you say customer focused, can you give me some examples of how the company values that?

: For me, what customer focus means actually, do you have sustainable relationships with the customer? Will the customer give you repeat business actually in terms of new projects, new products. If I look at the customers that we have at Jubilant HollisterStier, we have multiple customers that have multiple products specifically that we do for them from new products to actually existing products and even generic products. Something around our stickiness with the customer tells me we're doing something right.

And I'll give you one quick example. We have multiple COVID therapeutics that we did for some of our customers over the last few years, multiple ones. And not only have we been able to adapt, but we've also been agile in terms of finding fill slots or finding capacity opportunities for these customers to actually place these products and deliver them to the market, not only in the US but outside the US as well.

Now going back to the Spokane facility, I want to talk about the recent expansion you had going on there. Can you just tell me a little bit about exactly what was done there?

: Sure, so this is one of our exciting projects. We have two.

: We could have two major expansions going on. The one in Spokane is actually going to take our existing capacity and double it in an around five-year plan. We just announced late last year, this partnership with the US government $300 million expansion project that allows us to expand our sterile fill and finish products, specifically lyo liquid products in Spokane, doubling our capacity.

What's really exciting about it though, is actually we're bringing on isolator technology. So, today's technology allows us to work in an aseptic environment without human interaction. The benefit at the end of the day is actually we continue to have ultimately high, high quality, but now even better batch yields and ultimately yields for the customer. So what that means is a better even more high quality product for the end user and the customer.

Can you go into a bit more detail about the government contract and all that? How you get that partnership? Because that's a very interesting thing because a lot of times it's a private company, company to company partnership's going on. But when you're working $300 million contract with the government, that's super interesting.

: Yes, so part of the partnership is the government is looking for a partner, specifically in the US, a partner to actually build up capacity for a future pandemic or future issue. You think about COVID that was a recent one where we needed to have manufacturing capabilities to actually meet the needs out there should there be a pandemic or another issue. Likewise, we partnered with them, through their funding, to ultimately have the capacity available should there be another pandemic or another threat to society. This allows them to have on demand capacity should they ever need it in the future.

Building on what we've been talking about here, can you just describe the strategy behind the expansion at the Spokane facility? Like, what led to this decision at this point in time? Was it the customer demand, greater industry trends, a blend of reasons?

: I think there's a few things that I can describe in terms of what led to that. One is, we knew there was a need in terms of the customer need for expanded capacity. If you look at today, customers are looking for more sterile fill and finish capacity out there, so we can meet that need.

But if you look into the future, the COVID situation over the last few years highlighted an urgent need to what CMO companies could be adaptable and could be agile, to actually meet the needs of a future pandemic. That was probably the biggest driver to enter into this partnership with the US government, and to expand and double our capacity. So now we are basically going to have double the amount of capacity we have today, but also we've shown to that we could actually be agile and adaptable, should we need to actually produce more batches for a future pandemic, etc. So, the second aspect that I'd say is actually building for the future.

And then I think the third aspect is the stickiness that we've developed with our customers, and our relationships. If you look at all of our customers out there, the multitude of them that we have, we have five to ten year long-term relationships. Point one. Point two is, each of those customers, we started with one product, or maybe one new product introduction, and now we have two, potentially three products with these customers. So there has to be something that we're doing right in that secret sauce, in terms of that sustainability and that stickiness with a customer. And I think it goes back to our vision around customer-focused, high-quality, full-service, you know.

Taking a step back, 10,000 foot level, how would you describe the state of the outsourcing industry?

: Yeah, 10,000 foot level state of the outsourcing industry, we look at this all the time, because this is our business, this is what keeps the lights on. And I'd say if you look at it, it's growing approximately 9%, the market in North America and specifically in the US. So it's a robust market that's growing.

And actually, if you look at the shift between in-house versus outsource, it's actually slightly favoring outsource, so for us, I think our sweet spots are a few segments within the outsourcing space, the CMO spac. One is Big Pharma, the other one is specialty, the other one is biologics, and then the last one is generic companies. Specifically those who are looking for a partner that puts the customer first and ultimately needs sterile fill and finish, liquid and Lyo products, or ophthalmic niche products as well.

Not to quiz you or anything, but when you talk about the 9% growth in the outsourcing industry, are you seeing that that's coming from new companies, like new players in the industry? Or is it more so people switching over?

: I think it's just a move of people are trying to find redundant opportunities. What I mean by redundant is mitigating the risks of single-source providers. So it's a mix of existing companies and products, and then it's some who are actually going to an outsource model.

Very generally, you could either buy or build a technology or capability. Buy it is, actually I'm going to partner with the CMO organization, like Jubilant HollisterStier. Build it is, I'm going to actually do in-house manufacturing. What you're seeing is both of those can be risky if that's your only strategy, so it's a risk mitigation strategy and that, I think that's why it's actually growing.

That's a theme I've seen going on in my interviews with DCAT. It's like a lot of people are talking about the mitigation because I do feel like there's a lot of perceived unsteady instability in markets in general. But just, you look at the SVB collapse, for example, like they failed because they put all their eggs in one basket, so I think a lot of companies are like, "We'll have some in-house, maybe license a clean room, have some CDMO." And then all that sort of stuff.

: We just talked to, just to build on that, we just talked with a customer today, where they predominantly do in-house production, and essentially, I asked them, what's their strategy? Do they want to buy? Do they want to borrow? Etcetera. And what they said is, "We're looking for redundancy.” We're looking especially for their blockbuster products, you know, hundreds of millions to billions of dollars. You've got to have a supply chain mitigation strategy, for sure. And this is one way to do that.

Expanding from that, can you talk a little bit about the state of the broader biopharma market and how you perceive it to be?

: That's a big question, so I'm going to actually interpret that question.

: I see some consolidation going on in terms of the market; let's take the ophthalmic market, in particular. So you have a lot of consolidation, you have two, maybe three big, big players that are consolidating or buying up the little houses. So on the one end, that's good, if you have a partnership, or you're the CMO of choice for these big companies. But on the other end, you lose some of that leverage if you're not already part of that sandbox of those big conglomerates. That's happening in the ophthalmic space, specifically in the US.

I think on the non-ophthalmic, so sterile liquid Lyo space, what you're seeing is a mix. The big sweet spot for me is specialty biologic products, lyophilization products. There's a need for sterile fill and finish, specifically in that space, and there's lots of midsize and small specialty and pharma companies that are actually just growing, or have one product that's actually late-stage development that they're looking to actually have a manufacturer of choice. That's exploding and that's growing and I could see that only continuing to grow, as you have more of these, these folks that can actually show that capability, like us.

If you had to illuminate one technology or practice in your space that you feel is often overlooked, what would like to put a little bit of spotlight on?

: So, I'll answer that question and I'll close with what I think our unique value proposition is.

: So I think some table stakes, or what perhaps might be overlooked, to your point, is quality. Key one; there's no black and white on that one, you've got to have high-quality product. The other thing is advanced technology. We're actually advancing our technology with the isolator technology that I spoke about earlier, that allows you to work in an aseptic environment without any human interaction. That's often overlooked. To me, that's going to become a table stakes in the future if you don't address that. So that's the second one.

I think the third one is really being clear on what your value proposition is. Rather than trying to be the jack of all trades, are you an expert, and are you a master of sterile fill and finish liquid and Lyo products, parenteral products? Yes, we are. That's our sweet spot. Versus, I think companies try to do a lot of a little and they actually aren't a master of one so they sacrifice quality or some of these other aspects. So I think those are things that are often overlooked, or sometimes diluted down.

In terms of Jubilant HollisterStier now, I think the message I would leave out there to you and to anyone is, our sweet spot is sterile fill and finish and ophthalmic. But our vision, and what stands out, I would say, for us, is that we're a customer-focused CMO. And we want to try to provide that white glove service to all of our customers. A lot of companies can say that, very few companies can say, hey, any day that if you have any company down there, they're interacting with the president, they're interacting with the head of quality, they're interacting with the head of technical services to actually transfer this product. You get the A team every single action, and that's what a white glove service actually looks like from us. And I think the testament or proof point to that is the fact that we have these sustainable long-term relationships with the customers with multiple products actually within these companies.

I really like that example of the white glove service because I do think a lot of companies use that term and then they don't really reinforce it. And they don't really show that in the practice, so that's really informative to hear.

Do you have any bold predictions for the outsourcing space over the next five, ten years?

: Yes, I do have some bold predictions. I think the outsourcing space is going to consolidate. Folks are going to get actually more specialized. You're going to have the big players, you're going to have the big players, I'm not going to mention their names, but everyone knows who they are. They have 50 manufacturing plants in the US and they're going to continue to actually partner with Big Pharma and be the manufacturer of choice.

In the small to mid-sized company, there's not many companies, there's less than 100 in the US. I don't see that actually growing; I see that actually getting even better, and a few select companies owning even a bigger portion of that pie by having some of those things I mentioned earlier; high quality, customer focus, isolator technology, advances in technologies, having those things and having them really, really well, mastering those things. So that's what I see happening in the space.

So when you say that, do you mean in the sense that they're going to refine their practices and become more efficient? Or are they also going to grow at some point? Do you think they're going to stay in that mid-size range?

: They're going to do both. You've got to continue to refine; I would change refine, to me, it's optimized. You've got to optimize, you've got to find efficiencies, you've got to figure out where you can remove cost to keep the lights on. But why you do that, those savings, you actually translate into your future expansions. So, our great examples on both our Montreal site and our Spokane site, we're expanding both of those and doubling our capacity on both of those sites. The only way we're going to do that is if we actually drive efficiencies with our current state as well.

For more of our coverage on DCAT in 2023, viewers can visit 

Articles

Chris Preti, CEO of Jubilant HollisterStier Contract Manufacturing Services, shares insight into the outsourcing industry.

Exploring CMO Strategies with Chris Preti (DCAT Week)

Following up a Washington D.C. event in early May, members of the 

 to toast to the good health of the alliance itself, and also for the myriad new therapeutic possibilities in areas as diverse as oncology, neurology, cardiology and infectious diseases more broadly. World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration. Further, the US hopes to produce enough vaccines for the US and the world in 130 and 200 days. Past preparedness efforts have focused on innovation and reliability—culminating in the novel mRNA vaccines. Today, it’s important to consider diverse responses—and how we can make the investments we make today sustainable and “ready” for when an emergency happens. But while the last pandemic helped usher in this new era of commercial scale mRNA platforms, AMM itself rests solidly upon four principle pillars.

The next step for the Alliance is to engage with regulators and lawmakers at a congressional briefing planed for mid-September on capital hill. In terms of policy AMM advisors will engage with governments, policymakers, regulators and other stakeholders in North America, Europe and Asia Pacific (according to its website) “…to advocate for policies that encourage innovation, define regulatory standards, support manufacturing and promote access of mRNA medicines to patients.” (1)

Regarding their plans to advance knowledge, AMM “plans to bring the best minds together to overcome the most critical obstacles inhibiting the advancement of mRNA research, development and manufacturing. Furthermore, AMM will forge inclusive and collaborative partnerships with other networking forums to co-publish, augment or improve upon technical and scientific content generated by these groups.”

One of the initial council members, Baley Reeves, Interim Director at the National Center for Therapeutics Manufacturing, Texas A&M University, stresses that"In order to support the development and manufacturing of mRNA vaccines and medicines, a skilled workforce is critical component of the overall ecosystem. The lack of a pipeline of workers trained in the specific processes required for mRNA manufacturing is a major bottleneck for the field." The rapid evolution of mRNA medicines since the inception of the COVID vaccine has created a need to (1) elevate the understanding and perception of mRNA medicines to the general public and (2) develop and expand the pool of mRNA talent in the industry. From their website, AMM states it “will champion causes and projects to educate the community on the potential of mRNA technologies to improve the human condition and collaborate with institutions to uplevel and standardize the education of mRNA scientists and to retain them in the field.”

And as their last pillar, “AMM will serve as the leading convenor of mRNA stakeholders, bringing together innovators in the field to propel the future of mRNA medicine and advance scientific knowledge.”

Its an ambitious set of goals for sure, but amongst their number AMM already boasts of multiple scientific society, pharmaceutical and regenerative medicine global bodies and organizations. Combined, they have the talent and experience to navigate successfully toward not only their next goal (an early November full launch in Berlin) but also the goal of effecting positive acceleration of multiple medicines well beyond their initial vaccine starting point.

World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration. 

mRNA Global Alliance Tests the Waters at BIO

The BIO International Convention 2023 was held from June 4 to June 8 in Boston, Mass.

Its been a while since I attended the BIO conference, this year held in Boston. I’d forgotten how key a feature the speed dating booths are to the success of many attendees time at the event. Post pandemic these booths were figuratively bursting at the seams with energetic conversation.

To follow-up an alliance dialogue with Scott Ripley, general manager of Nucleic Acids at Cytiva, I stopped by their booth. Having missed Scott, who took a flight home already, I wound up talking with their commercial lead Fiona Fitzgerald. As a consequence Fiona attended the 

 (AMM) soft launch reception, which consisted of very high level industry leaders participating in support of this Alliance, 

Cytiva then expressed interest in not only learning more about AMM, but learning more about the wider therapeutic application mRNA is now being turned toward. In return I wound up learning a good deal more about Cytiva’s nucleic acid group and what their future plans pivot around. The newly formed nucleic acids team at Cytiva supports customers throughout the manufacturing workflow for oligonucleotides and purification of mRNA drug substances. In collaboration with their colleagues at Precision Nanosystems, they help bring mRNA lipid nanoparticle therapeutics to market.

BIO is a powerful business development conference and can help make a lot of deals become reality. It’s power hinges on its ability to draw in the best and the brightest from all of Biotech increasingly extensive web of activities.

BIO is a powerful business development conference that can help make a lot of deals become reality.

Business of Being at BIO

, is organizing the next Cannabis Science Conference Fall meeting in Providence, RI, which will run on Sept. 20–22, 2023. The conference is looking for speakers to share their knowledge on a variety of topics including analytical science, medical cannabis, cultivation, and psychedelics.

The event is currently soliciting a call for abstracts. Please submit your talks for consideration to the 

2023 Cannabis Science Conference Fall Abstract Submission Portal

. The deadline to submit abstracts is June 2, 2023.

The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.

Cannabis Science Conference Fall Meeting Issues Call for Abstracts

Myrna Wilson, director, Global Marketing, Strategic Growth and Technical Sales, Pharmaceutical Ingredients, Univar Solutions, spoke with Grant Playter, associate editor, to discuss the state of the pharmaceutical ingredients industry shortly after this year's DCAT Week. Topics of discussion include the state of the biopharma supply chain, movements in the patent industry, and more.

Broadly speaking, can you give me your perspective on the state of the ingredients industry? Would you characterize it as in a state of flux? How can companies look to strategically maneuver in this space?

: As the world economy continues to recover and evolve post-pandemic and with geopolitical tensions, the ingredients industry is not immune from the impacts of those financial conditions.

As with most industries, the ingredients industry is constantly in a state of flux as it must continuously respond to global supply chain challenges, and – specifically as it pertains to pharmaceuticals – the need for drug manufacturers to continuously improve the medicinal efficacy of their offerings. Also, the increased focus on environmental, social, and governance factors means the ingredients industry will have to evolve to ensure it is either working on how to manufacture its product offerings with environmental footprint considerations or consider alternatives to its current lines that can address those requirements.

Strategic maneuvering all depends on the long-term strategy of each company. However, there are a few elements that should remain at the forefront of a strategy in this industry. For Univar Solutions’ pharmaceutical ingredients team, it means that as we position ourselves to respond to external dynamics, we always consider quality, security of supply, traceability, and documentation of adherence to quality and regulatory standards. If we keep those in the forefront of our planning, we are sticking to the core of what our customers need from us.

We recently passed the three-year mark of the COVID-19 emergency declaration (March 2020 in the U.S.) but many are still talking about its impact on the supply chain. What is your perspective on these alterations? Do you think the just-in-time model may return in full force at some point, or will efforts like onshoring stick around in the long-term?

: COVID-19 pushed the industry to respond faster and to become more efficient than ever before. It also highlighted supply chain pinch points and forced the entire pharmaceutical industry, and far beyond, to make swift moves to sustain the pressure. While I don’t think our industry has completely recovered from the many supply chain constraints we were presented with, businesses up and down the chain are making changes to their core infrastructure to better position themselves in the long-term.

Shortages that have gone unresolved over extended periods of time have caused the industry to either create or adapt to new supply sources or alter their existing supply chain paths. These sorts of adjustments are often both costly and time consuming, making it unlikely that entities would work to undo new paths created. Additionally, many may have found secondary benefits with these alternative paths, such as improved sustainability outcomes and supply chain optimization.

Also, there has been a push by government entities around the world to onshore their internal access to secure the health of their citizens, even offering incentives to build infrastructure within their borders. Again, the cost to make these moves is significant. Once those investments are made, it would be difficult and costly on a variety of fronts to undo them.

What are some recent technological innovations in your space? Can you illuminate them for our audience?

: Univar Solutions prides itself on the fact that we have a global network of pharmaceutical laboratories within our solution centers which serve as pharmaceutical application and formulation laboratories to help support the road to innovation and reformulation for our customers and suppliers. Because Univar Solutions sits at such a key intersection in the supply chain with science and technology, we strive to be a true solutions partner delivering benefits far beyond logistics for our customers and suppliers. Distributing the chemical or ingredient is only the bare minimum.

In terms of innovations based on trends in the pharmaceutical space, there has been a significant shift toward creating more palatable drugs and taste-making active pharmaceutical ingredients (APIs). Due to the influence of Generation Z on the drug market, today there is increased focus on not just the efficacy of a drug, but on its taste and ease of consumption.

As an example, drug manufacturers now can create products specifically engineered to deliver two APIs that are unstable when combined with one another. These duo-capsules are game-changers for drug manufacturers and consumers alike, while also delivering significant benefits in sustainability.

Patents are in a bit of an interesting space at the moment, particularly in the United States. The Inflation Reduction Act was signed into law last year, which introduced new price controls and changed how certain drug exclusivities work. Meanwhile, broad genus clauses recently faced challenges at the Supreme Court level in the Amgen vs. Sanofi case, which could have upended how patents are handled in the biopharma space. Can you talk a bit about how the patent industry is preparing for these significant changes?

: The pharmaceutical industry is facing a big patent cliff. It’s creating urgency among manufacturers in the generics space in the race to get their Abbreviated New Drug Applications (ANDAs) in place so that they can enter the market with their generic. Simultaneously, large pharmaceutical companies who may have held back research and development projects so as not to cannibalize their current product offering in the market may be releasing the follow-up much faster than planned.

Between patent battles, competing offerings, the likelihood of success through the trial process, and the massive cost to take a drug from clinical trials to commercialization, the pipeline of projects should be constantly refilled. It would also seem prudent for drug manufacturers to weigh the commercial viability of their projects by ensuring that their recipes consider cost and security of supply of any materials built into the formulation in earlier trial phases.

As a distributor, it’s a partnership that we aim to offer our customers. It is critical that sourcing and cost implications be part of the planning as production needs to scale up. If a manufacturer partners early with us, we can source, provide secondary sources, and design efficient supply chains that consider quality and security of supply from small quantities to commercial consumption.

Do you have any bold predictions for where the biopharma industry will be ten years from now?

: The rate that technological developments accelerate in any space is increasingly exponential, and the life sciences industry is changing and evolving at an amazing pace. A 10-year prediction would be truly hypothetical based on where research and development are currently focused. Personalized medicine developed based on each person’s body could be leaps and bounds from where it is now. The biopharma industry already has a promising pipeline of therapies being evaluated for cancer treatment and rare diseases. Hopefully, the brilliant minds working on the next wave of projects will work to eradicate some of these rare diseases and begin finding cures for even the deadliest of cancers.

Idealistically in 10 years, targeted gene therapy can be used for everything, not just limited to rare diseases or those that scientists know the molecular pathways for. This could result in sought-after cures, with little to no side effects. The intensity around curative therapies for chronic conditions along with advances in early detection technology could reduce the need for medications considered to be lifelong medications.

An increasingly aging population with a longer average lifespan could also provide a new source of challenges for the biopharma industry, as scientists look for a way for to keep the population living with relatively good health and mobility into their 90’s and 100’s. Finally, 10 years from now, with that aging population and the continued push to make health care more affordable for everyone, we could see big movements to somehow make these sizable developments more accessible.

Myrna Wilson, director, Global Marketing, Strategic Growth and Technical Sales, Pharmaceutical Ingredients, Univar Solutions, discusses the state of the biopharma supply chain, movements in the patent industry, and more.

Investigating the Pharmaceutical Ingredients Industry with Myrna Wilson (DCAT Week 2023)

Andrea Lodetti, CEO of Bormioli Pharma, an Italian pharma primary packaging manufacturer, spoke with Grant Playter, associate editor, at this year's DCAT week. Topics of discussion include the company's approach to the US market, supply chain instabilities, sustainability, and more. A full transcript can be found below.

One of the big headlines Bormioli is coming into DCAT with is its 40% increase in North America sales year over year. Can you discuss some of the reasons behind the strong increase in terms of new strategy, certain investments, market forces, et cetera?

: Thank you for the question. I would say it's not the new strategy, we started the approach to the US market back in 2019 when we set up our commercial entity. The timing to get things done in pharma is quite long so you have to invest, especially in time, with money. And so what we did we started our commercial activities and our interaction with customer, showing them what were the benefits from our product, how good we were performing. Also, in some places of the same global pharma company in Europe, we're saying, "Hey, we serve this plant in Europe, why can’t we also serve your plant in the US." So, it all came with the longer work.

Of course, there were a couple of things in the last three years that made things a little bit not so easy as in the past. But we did work a lot in that; we set up our logistic platform here in the US, we have a very well-streamlined supply chain from Europe to US, especially for molded glass. And that is making us more and more credible, and customers that start working with us have immediately increased their volumes and ask, "Okay, you can do more?" And this is why we now are benefiting from this acceleration that is overall in the market, because after COVID, after the crisis we saw in the Russia and Ukraine war, all the pharma companies are nearshoring their supply chain a little bit more than in the past. I would say pharma has been always a risk adverse sector, but in terms of organizing its global supply chain, it was more looking for efficiency, cost efficiency, rather than risk protection.

And what happened during COVID, and also in the in the last 12 months, everybody realized that you cannot afford any more to have your things supply there from the other part of the world. You can do it, but then when things become difficult, then you're immediately in trouble. So we're trying to follow up with this. So I think we will also invest a little bit more in US now and get possibly also an industrial footprint on site. But again, this is a long, long activity that is now paying back and we're quite happy about that. I think there's more to come later on.

You touched on this a little bit. But regarding the extended half-life of the COVID-19, disrupted the supply chain, do you think this basically spells the end for the just-in-time supply model? Or do you think we're going to look towards more onshoring production or whatnot?

: I mentioned the nearshoring or reshoring of some of the activity. I'm not saying that this is the end of the just-in-time, but definitely has to be redesigned along different concepts. I would say that, for instance, for glass production it was never a just-in-time because normally pharma companies they do buy at the very beginning of the year of what they need, and then they use it all over the year. So, it was never like a pure made to order.

But anyway, as I said before, what is now important is to make sure that you have a backup plan for any of the possible risk of disruption that you are facing. This is staying, because it's not like COVID-19 is now over — no, this is staying. It has hit us strong, and also following it up with the macro-economic crisis that we are living nowadays, it really has made everybody rethink that things are not that easy as we thought before. And we have to be sure that things are working perfectly, because in our segment in our industry we have a social responsibility. I mean, if people is left without health care, it is a big issue. And the risk was there during COVID-19 and I can tell you, we had a number of customers scared to death that suppliers were not able to provide the continuous API or whatever. And this lesson is being learned quite well.

So our audience is largely composed of biopharma industry members, but they might not know this between molded and tubular glass. Can you just talk a little bit about this in the biopharma context?

: It's a different process, because molded glass is a process that we dominate from the beginning to the end, where you really start from raw material like sand cullet and you come out with the finished container afterwards. With a little bit of different technology, but basically what you do is you melt all of these stuff in a 1600 degrees container and after that, you pull out a small portion of melted material that is then formed into different processes. And that is normally used for container that go from 30 ml up, so with the bottles.

When you go down, you move towards the vials, then you have the converting a glass, tubular converting technology that comes in. This is a technology you start from a pipe of glass that is made only by four companies in the world: Nipro, Schott, Corning. Three companies, actually, the good ones. And you buy these pipes, and then they run a cutting, heating, and forming process afterwards.

So, what is the benefit? The benefit is that you come out with a smaller container, because with the mold, you can go down to a limited capacity. And then, if you do things properly, the container is lighter, is less heavy, and has a better aesthetic look.

However, there are things that are good for the tubular technology, things that are much better with the molded technology, so it's always a trade off around capacity application and mechanical characteristics that you want. We demonstrated with a dedicated activity, as we mastered both technologies, that there is a huge, on some properties, you can really choose depending on the size and the aesthetic of the vial, but there are things for which molded is much better than tubular; for instance, stability over time, internal uniformity of the chemical aspect inside of the container, and also molded glass has not the issue of delamination, which is an issue that affects the tubular vials.

So, I would say different technologies, different processes, Bormioli can master both of them. We can also provide consulting to small companies, you mentioned the biotech; of course, these are company that totally focused on the drug, on the content. We are good at designing and developing their containers. So whenever we see that whenever we work together in the development phase, things are coming out much, much better.

Talk to me about the 50-in-5 program. Just, what are its goals, how you went about this, because everyone wants talk to me about sustainability. It's the new hot topic at DCAT this week.

: But we need to discriminate from greenwashing and real sustainability. Today, everybody's talking about that.

I watched this segment the other day talking about carbon offsetting. How a lot of companies who are carbon offsetting aren't really actually doing that.

: I want to be carbon-free. Okay, then there's a lot of work to do. And we came with this project that we call the 50-in-5, because when we launched, that was like two years ago, we said, "In five years, we want to get at least 50% of our raw material coming from recycling or sustainable sources by 2025." This means for molded glass to work a lot around the loop of collecting the cullet and using it back into the furnace.

And we are quite advanced with that on the plastic side, in the means to use any type of recycled material that comes from all sorts of industries and use it and convince customer that this can be used and has the same properties as the building material. We are on track for that; we have reached 39% in 2022. And we think we can get up to 50% in 2025. Also, because many of our customers are now in the rush of achieving a sustainable result. So, that will add quite a lot.

The last bit would be a little bit more help from regulatory bodies, that they have to allow a wider usage of recycled material. For instance, nowadays, there is a minor portion of whatever is used in hospital that you can put back into the recycling loop. So, we are also working on that, trying to make activities that basically demonstrate that you can collect material from the hospital with no harm for the people and put it back into the recycling loop.

Can you talk about that a little more in detail? Like say I have a vial and I put like, say COVID vaccine in it, and I use it and how would I go about recycling that while maintaining absolute sterility? Because that is what you need for things are going to be reused.

: So in order to ensure sterility, there's only one way, that is heating. And if you think that in the end of the cullet goes into a furnace at 1600 degrees, you are sure that whatever enters there, doesn't come out. Not alive, at least. So the real issue is the collection from the hospital up to the place where you fragmented it and then to the melting furnace. This is the area in which we have to work.

So our idea is that there is a first step of, I would say, sterilization or cleaning that can happen at the hospital level. So the hospital with a, not a huge facility, like imagine a container that is heated at a certain temperature can ensure that what gets in there is then free of virus, of contamination, and so on. And after that, the whole recycling loop is already defined for water, for food. And so just this step that has to be handled, because unfortunately, today, whatever goes into the hospital then goes to the burn on-site. And then that's not good for being sustainable.

We're in a weird state with the greater global economy. There's obviously a lot of geopolitical events going on in Europe at the moment and we also have the SVP collapse affecting the global market 

 Dow Jones is down, that sort of thing. So can you give me your perspective on how this is going to impact the biopharma space?

: For the pharma environment? This is an industry that requires a lot of investment, a lot of capital, a lot of money, but is pretty much backed up also by healthcare institution — it is a very much protected system. So it's difficult to make very, very, very wrong financial disasters like it is in some other industry. So, you don't have so many startups that are happening and needing a lot of money like in the high tech business, so, I do not expect any of the pharma player to be [affected] so much. There is only so much contagion that can get into our industry.

But on the other side, we have to be aware that not all the financial sources are any more as reliable as we thought in the past. And this is something that I think in our space is less affecting the business than in other space. We must be more aware of what is happening in the public healthcare system. That is really driving the performance of the pharma chain. If broad initiatives are taken by government in this space that you haven't, you are affected in the industry.

However, what is good, if we have to find something good about COVID-19, is that it has brought back into the agenda of the government and public institution. How important is it to ensure a solid and reliable healthcare system for these events that we understood, that can happen at any time, and they are quite fast in spreading around. And so I am confident that our industry will not be affected that much by this crisis.

And about the crisis in Europe, ongoing in Europe, unfortunately, this is very bad. But both Russia and Ukraine are not such a big player of the pharma industry. What I can see there is that, of course, there is a drawback in terms of reliance of government into each other, but not really a disruption that is relevant for our business.

Very fair take. It's an inelastic demand for this. The only concerns I really think people are highlighting are like with the startups, because investors might be a bit skittish for high-risk, high-reward startups, specifically in the biopharma space, but on the supplier end, which is where you're coming from, I don't think you're going to see much change.

: No, no. In this space, where we are coming from we don't see things much affected. The R&D investment will stay, we are keep on investing into that space. So at least for packaging industry, I don’t see that as a big issue.

I'm asking everyone this question, going to ask you it as well. You have any bold takes about the biopharma industry? Where are we going to be five years from now? Ten years from now?

: I like the space, is very much interesting, and is going to be supported a lot by the advance in other areas, like artificial intelligence, or high-speed computing — everything that is, you know, growing in the high tech environment, is bringing to biotech a lift. And this is where we have to go, right?

If, when we talk about personalized application, or very specific drugs for the so-called orphan disease, I mean, there is where we have to go. I mean, the standard was a classical pharma industry, works a lot on chemicals, on things that are good for everybody, don't care that much about the drawbacks effect, because what you are curing is the main thing. With biotech, you can go into really the DNA of people and try to assist it and to come fix it, if there is anything wrong. We saw it in the vaccine, which are the vaccines that work very well, they were the one that acting on the mRNA, rather than the one acting on the death virus and creating the antibody and so on. So that's the future.

And probably, we will see more and more big pharma companies acquiring small, high-performing biotech. So we'll have this increase in this kind of network of different developing hubs that when they get to a point where thing is found, then it is acquired by Big Pharma. So I see Big Pharma going into more being the hub that acquires whatever is developed by single companies, and going out more and more from the bottling and taking care of the distribution is not their topic. So that is where, what I think. Recently I have seen, I think Pfizer made-

: Wow. Credit Suisse was just acquired by three million from UBS, three million for a bank. And yeah, 53 billion is more. But if you think about it, if you get things done in that space, you're good forever.

One other question, before we get to final thoughts. I was just curious. If you would give one piece of advice when talking with biopharma companies who are making decisions about their packaging choices 

: This would be advice for everybody. Remember, people that use your drug will now be people with the disease, will be people maybe needing support from other people to get the medication. So the packaging cannot be like, I buy a vial that is there since many years and I just use it. No. Remember, people will have to use it in a time where it's not in good shape, where he would have limitation possibly in what he can do, or she can do, would have maybe cognitive limitation. So it will be difficult.

So remember, remember, remember, there is a patient at the end. There is a patient at the end. So of course you are saving his life, he's happy, he will take whatever, do whatever to get this drug. But if you can make his life or her life a little bit easier, then you've done a good thing. So I mean, I see treatments that go in drops for blind people. I mean, how a blind, but they're very good, so they can maybe hear it and, but why don't you make something that they can use it? Or a lot of drugs that are used for people that gets amputations that you need two hands to open? I mean, why do you do that? It's something that you have to take care of.

: Accessibility is a very important thing. Plus, nowadays, also self-medication is increasing. And COVID has made a huge step forward in that because people was not able to go to the hospital or to the doctor. So self-medication is important. But of course, the more that you allow people to self-medicate, and the more you have to have the packaging that helps them in the adherence to the administration of the drug. Because if they do wrong things, then they don't get good treatment.

I'm aware we're low on time, but do you have a concrete example of how you can make like glassware accessible?

: Glassware, more accessible? I mean, the total packaging you have to look into to make it more accessible. I may give you an example.

We are selling quite a lot of oral liquid application, especially for the antipyretics for children. Small children, when they are on fever, they cry. And you have to feed them with the oral liquid. So the standard application is a bottle with a syringe to have this, open the bottle, put the syringe, then make the right sizing, and then put it in the mouth of the baby, and then having him sucking it.

So we made this ethnographic with some moms. You see, you have to be, all of this operation. You have to check it and then put it in. And we did it, and we were explaining this to some mothers, you have to do this, very simple, easy, and they say it's very easy, but you have a baby, you're holding a baby that is crying. And you know, you cannot put them in, so how do you do it?

So we came up with this other solution, where we have put a kind of dosing system on top of the bottle and is like, I don't know if we have a sample here. But basically, what you have to do is just turn the bottle around with an end, push on the container, here you have the indication on where the content that you have applying goes, then you turn it up, you open it, and then there is this kind of biberon, like kind of bottle for babies, shape, and then you feed it like this, so you want it, you just put it there and do this, instead of doing this. But also from the look, you see this is very, you know, hospital things. The syringe, the thing-

If I'm a little kid and I see that, I'm running.

: You're scared already. You say, "What is happening?" Whereas if you see like a normal bottle, you just push it and you get it done. And then you feed your baby. I think that is one solution that can help.

Fantastic. Do you have any final thoughts you'd like to share with our audience?

: I will touch most of the things regarding today, is very much keen in the making health a positive practice available to everybody and kind to the planet. And in this sentence there is all what I spoke about.

Andrea Lodetti, CEO of Bormioli Pharma, an Italian pharma primary packaging manufacturer, speaks about his company's approach to the US market, supply chain instabilities, sustainability, and more.

Unpacking the Pharma Packaging Market with Andrea Lodetti (DCAT Week 2023)

Shabbir Mostafa, head of Business Development — Advanced Delivery Systems, Recipharm, sat down with Grant Playter, associate editor, during DCAT week to discuss the current state of inhalations forms and drug delivery. The full interview transcript can be read below.

Broadly speaking, if you had to isolate one overwhelming drug delivery trend, whether that's in development, regulatory approvals, or even commercial markets, what would you say is the most impactful at this moment?

: I think for inhalation in particular its sustainability. So at the moment, we, within the metered dose inhaler (MDI) marketplace, use propellants for the user, for the formulations. And these propellants have high global warming potential. And now, these propellants have kind of been slowly phased out from the regulatory side. And they're looking to replace those propellants with low GWP, or low global warming, potential propellants, which are at quite an early stage in terms of their development.

But the environmental, the carbon footprint isn't going away. So there's a real problem at the moment of changing, of moving from high GWP to low GWP propellants. Because the expectation is it's going to be a lot of cost in terms of your development, your clinical batches, and also modifications to your facilities.

So, a number of the big companies that are big players within the inhalation market have already started to move over and started to transition. But there's a lot of other companies behind at the moment that haven't transitioned yet, and are looking to see what the regulatory side will be in terms of what they will have to do as they move across. And so it's quite an important area within innovation, because it's such a large market.

Just building on that a little bit, you say the low GWP are early in development, and some companies are beginning to transition. Can you expand on that, do we have any sort of timetable?

: The phase down is starting to happen now. The high-GW propellants — the products that are currently used today in formulations — they're going to be transitioning sort of to a lower point. They can only sell a certain amount, as it goes. And it's a step down process over a number of years, so by ‘25, ‘26, the amount of propellant available will be very low.

The proponents are used in lots of different markets. And actually in the medical side of it, the medical use is very low, but there was an exemption for medical use for these propellants. However, that exemption has been now taken away, so this step down process is now affecting also propellants for the medical use as well.

Are there any other sustainability measures you want to highlight, anything you can point to as a big trend?

: I think everything comes to sustainability. So they look at the carbon footprint of the factories. Are we doing things like solar power, how are we doing recyclables, etc. is huge. Actually, within Recipharm, in general, sustainability is a huge, huge area, we have people dedicated to that to look at how we can get become a net zero company. So it's huge within the pharmaceuticals.

Can we talk a little bit about like nasal delivery and just broadly inhaled biologics, what's going on in that space?

: So nasal delivery, I think, is becoming more and more popular. Traditional nasal delivery was multi-dose delivery, just your normal nasal spray that you'd use for anti-allergies, etc. But now as you've probably seen, there's what we call one shot unit dose delivery devices, which basically shoots one dose into your nose, and that's been used for things such as rescue medicines and immediate pain relief.

As Recipharm, we've developed a device for single-dose delivery, and it's going to be used in those areas, and as you know, with rescue medicines — its for people overdosing on things like fentanyl — so they need to have this straightaway rescue medicine. Just gives you one shot and you get hopefully relieved from the overdosing of the fentanyl.

What are some observations you’re seeing in terms of inhaled biologics?

: So, from an inhaled biologics side, we're starting to see more and more customers looking for that development. There's two areas which you can go in; the biologics one is either a nebulizer or dry powder inhaler. But the nebulizer, which is a solution, it tends to be quite high-shear, so it can destroy the large molecules as it's being inhaled. So, there's a challenge using nebulizers for biologics.

We've developed a soft mist inhaler, which is one of our newest devices, in partnership with Medspray, where we have a company called Resyca. This soft mist inhaler is very gentle. And we're working with a number of customers biologics, large molecules, for mimicking of the nebulizer route.

The other preferred route is through DPI, dry powder inhaler, where you can spray dry your active or your biologic onto something, a carrier. And that's starting to show some popularity now. The issue with DPI has always been reproducibility. And so that's the challenge with inhaled biologics at the moment, making sure we still get reproducibility of the active.

From a development perspective, can you talk about some of the considerations that go into selecting a drug delivery system? Like what's the discussion when you're selecting between like, say, a nasal inhalant versus an inhalant one would use for asthma?

: So asthma disease is straight into the lungs, so it's looking for respiratory delivery, so you would use an inhaled, so either an MDI or a DPI delivered, or a nebulizer delivery. If you are looking for something for an immediate sort of pain relief in the head like a migraine, you'd probably go through your nasal delivery, because you've got the delivery faster.

Pfizer just had the migraine nasal spray approved the other day, I believe. 

[Editor's Note: This interview was recorded on March 18th, 2023.]

: Yes, it has been, Pfizer. So that's why I'd say the difference is, if you're looking for a sort of respiratory, you'd go inhalation; if you're going for nasal things like pain relief, or as I said, rescue medicines, etc., for the nose to brain delivery.

Can you give me a bold prediction for the future of drug delivery five years from now?

: I think the market for inhalation is definitely going to change. I think we're going through this huge change, as I said with the MDIs, we don't know where that's going to be in five years' time, whether there actually is going to be a business for it, or whether everything is going to transition across the DPIs.

My suspicion, I think, is that there's going to be a hybrid, I think there'll be less of MDIS and I think there'll be more of DPI formulations out there in the marketplace. We, part of our business is huge, is MDIs and valves. So we still see a value for it, but we don't know what the market will be like because of the transition from high GWP to low GWP propellants. We don't know what the market will be like in five years' time. So I think that's the big thing for us. And looking at that and seeing where, you know, what will happen in the future.

: Ten years? That's difficult. I think that it'll definitely be the growth of inhaled biologics, I think, over a ten-year period. I think that biologics will be a lot more in the next five to ten years. I think for nasal delivery, again, I said it went through the uni-dose, so single dose shot for things such as rescue medicines, and it's quite big in America, in Europe, etcetera requirements. So that's where I see the market in ten years' time.

Shabbir Mostafa, head of Business Development — Advanced Delivery Systems, Recipharm, sat down with Grant Playter, associate editor, during DCAT week to discuss the current state of inhalations forms and drug delivery. 

Investigating Inhalation Forms and Drug Delivery with Shabbir Mostafa (DCAT Week)

Dr. Ulrike Lemke, Head of Sterile Fill Finish at Recipharm, sat down with Grant Playter, associate editor, to discuss drug delivery forms. Topics of discussion include drug storage, drug dosage, and the greater supply chain. 

A full transcript of the conversation can be found below.

What are some of the benefits of prefilled syringes?

: Prefilled syringes are a subset of the dosage forms that currently enjoys a lot of growth, and there are multiple reasons for that, and for an increasing preference, particularly in the high value markets, to go to prefilled syringes. One of the facts is, of course, the lower risk at the point of care to misdose.

The second very important advantage of prefilled syringes is, when it comes to filling a high-value API, you don't need to overfill. So in vials, you have single-dose, multi-dose vials, and then you need to extract, at the point of care, the volumes that you want to deliver to the patient. In the prefilled syringe everything is preset, so the risk of doing any mistakes is lower, and you can fill the exact volume that you need. In that regard, you preserve valuable API as well.

Now, what is a disadvantage of prefilled syringes versus other fill forms? Of course you need to have the storage space available for that, and that's why every technology has its pros and cons and you really need to understand, in the end, markets how your patient will need to be treated. There's no need of specific preparation of material or so, the prefilled syringes ready to go, that makes it a preferred option today,

Can you illuminate the process behind lyophilization a bit for our readers? What are some of the factors that we might not be considering?

: First of all, lyophilization is really freeze drying of formulations to make them more stable. The main advantage of this is you can keep sensitive compounds and materials stable for a longer period of time. So lyophilized products can often be maintained at ambient temperature, so you're avoiding cold chain requirements, and also the degradation in the dry form for sensitive product is much slower if at all present. And with that, you increase the shelf life of products. It is not suitable for every product as well, but often chosen for a really long term stability and storage reasons.

: You have seen this during the COVID crisis, so there are certain products, particularly in the vaccine space that right now need ultra cold storage, and when you want to hit less developed markets such as the African markets, it really puts constraints on how you can deliver these dosage forms. There are routes around this, and we have seen improvements also with ultra cold storage.

For example, the elongate shelf life of these products after freezing for a couple of days, in two to eight, but generally for markets that don't have these elaborate cold chains very well developed, I think a lyophilized product would be advantageous. At Recipharm we have done this in the mRNA space, for example in lyophilization, and that would circumvent some of the disadvantages of ultra cold storage. It's also costlier and you have to establish the -70, -80 degree storage, and then the question is the access to energy at point of care, so this makes lyophilization easier.

Now, here we come to a counter argument when you look to prefilled syringes versus fill form in vial, for example. In markets where you where you want to deliver to patients also cost effectively, storage space is a limitation. And then, of course, also the way that you want to deliver to the patient. So often you see multiple dosage forms -- or multiple doses in a vial, not multiple dosage forms, to just make that clear -- and it's advantageous to do that. Because it is simpler at the point of care or at the delivery to the patient you reduce the space that is needed. So prefilled syringes, for example in Africa would put a constraint on storage spaces in different countries.

I do think there's opportunity in the lyophilization space, especially given the supply chain disruptions we got from COVID. I know there was so much talk about vaccines expiring in storage, it was just very unfortunate.

: That's unfortunate. It's a waste of a high value API. But again, I would also like to stress the point that there are different ways of tackling it, lyophilization is one. But I think the other thing is to make the formulation more stable after thawing which were routes that we have seen customers taking, and we can support both. In the end there's always a good solution to it. I think we have alluded to lyophilization, but ultracold storage is something that we should not unnecessarily exclude, but it has constraints.

I'll refrain myself for getting further in the weeds, this is all very interesting. In the parenterals market, can you talk about some technologies whose impact might be overlooked? Because I know there's these heavy hitters of things that dominate the headlines, but I'm curious about the lesser known things.

: When you think of the market today, first of all, the market has moved a bit from terminal sterilization and to aseptic filling, and we're all talking about the standard dosage forms, which is liquid vial, lyophilized vial, and BFS.

One thing that we take a particular interest in, and that can offer new opportunities, is blow fill seal. We see some first applications in the vaccine space coming up. It's a cost efficient technology, but it is, as the name says, you blow the device, you fill it with the medicine, and then you seal it. There's certain energy or heat involved, so it doesn't lend itself to all kinds of applications. But we think that there is a potential, particularly in the vaccine space, but possibly also other applications in biologics that would be suitable. We're very interested in how this market is going to develop.

We're looking also into the early stages and are very happy to test formulations for customers that want to have a cost-efficient delivery form. One specialty in this is not necessarily a sterile delivery, but when you think about how you need to administer, particularly to children, is an oral route of a liquid into children, and that is another element where BFS could play a role.

Can you tell me about some of the key factors that you would take into consideration when deciding on a form of drug delivery specifically?

: Well, I think for every medicine, the first element that is really important is how do you want to deliver to your patient, and what is the dosage scheme? So how often does he get it, and what is the point at which the customer will receive the medicine? It's the self-administered, for example, or is this given at a point of care in a hospital or so. Then based on this, of course, you need to design your ideal dosage forms.

Other elements, and we alluded to this earlier in this conversation, is really also which markets are you targeting? How mature are they? What is the training status of the caregiver? How do you avoid any mistakes in the formulation? For example, when you look into a lyophilized product, you need to bring it back into the liquid phase at some point in time. So that requires a caregiver or the patient itself to mix the final medicine again. These types of considerations are what you want to look through before you're defining what your delivery form is going to be. So it's really patient centric, and also understanding what is the health system that you go into. There's a lot of constraints – I mean, we’re talking supply chain, we're talking training centers of the caregiver, we're talking the convenience for the patient itself — you want to avoid pain, so that's one important thing.

And this is physical chemical parameters really, is what kind of a drug substance do you have? Is this stable under certain conditions or not? How can you stabilize it? How can you elongate the shelf life of it? How can you improve the bioavailability of it due to your formulation? So, these are the technical considerations.

Last but not least, and this is also where we were focusing on a lot, is you want to think about the efficacy of the manufacturing process itself. So though we want to do this, we don't want to lose a lot of API in our manufacturing process. We want to make sure that when the dosage forms are being delivered, that this works from a distribution perspective. We have touched upon this when we looked into COVID and when we looked into what cold chain, for example, requires, what kind of space do you have available to store? What kind of customs borders do you have to do? So all these things matter because, for example, when you're very sensitive drug substance or drug product in the end, and you cannot break the cold chain, how do you make sure that this is happening?

All these considerations go in, that's not necessarily only considerations that we do for ourselves, but our customers, the pharmaceutical companies, the biotechs, the innovators, come with this thought process already, and we aid them in it. It's not a one fits all approach, that's why we see them mixing the different dosage forms, and there is always a question of how to serve the market that is a mix of multiple factors.

How would you evaluate the current state of the market in terms of drug delivery, specifically? I'm so curious, because I was talking with Gregor and I feel he does a lot of market instability in the greater biopharma space. But do you think that is being mirrored here?

: I would not call it, "This is an unstable market." If anything, what I would say is, first of all, due to COVID there was an increasing demand. I think there was an over focus on liquid vial manufacturing and speed of lines. I see that there is still a need for serving the mid-size market segments, so companies that don't have large volume expectations, but have smaller products for global demand and in smaller indications, and I think they need to be served really well and have maybe gotten a little less attention during the COVID years but now we're coming back.

I think there are market segments in which we see that there is a bit of an imbalance between supply and demand, and that is really in the high volume, large throughput liquid vial segment, where we have seen lots of investments coming in. And of course, we see a couple of new players appearing on the market that have yet to prove that they can work under aseptic conditions and can bring the sterile products to market at the required quality.

Last but not least — and I mean this keeps our industry on our toes, and rightly so — the continued expectations from regulatory authorities to push for more patient safety led to the annex one compliance framework that comes into place in August 2023, this year, and this is really to make the market rethink about what does it mean to handle a aseptic products? So what does it mean from a patient safety perspective, and that requires of course investments. I think this is all good, as long as the cost for the patients do not explode while we're managing continuous increase in safety for these types of medicines.

Dr. Ulrike Lemke, Head of Sterile Fill Finish at Recipharm, sat down with Grant Playter, associate editor, to discuss drug delivery forms.

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