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Treating change as a normal condition of organizations and utilizing new information that is taught to our organizations are two key components to making innovations in current good manufacturing practice (CGMP) training, according to a session at the 2023 PDA/FDA Joint Regulatory Conference in Washington, DC (1).

In the session “Innovations in CGMP Training,” Nkiruka Ogbuchiekwe, senior director, Leadership, Management, and Culture, Moderna University at Moderna, and Nicole King, associate director, GMP Training Transformation at AstraZeneca, both shared their experiences with transforming companies into learning organizations and what needs to happen to get to this point.

Ogbuchiekwe explained how learning culture must evolve, as it can be described as a “shift toward manifestation of how people in an organization experience the constant exchange of values, mindsets, and behaviors the harness the power of change.” These people are also either responsible for taking advantage of change or predicting it. “Change is happening, and if we are not actively building people today to be able to understand the nature of change, then we are failing in the learning and development profession,” she said.

In an example that happened at Moderna, Ogbuchiekwe said how she was able to help the company build a learning culture and experiment with data to feed back into the new learning culture model. Although these methods worked for Moderna, she emphasized that other organizations can’t take their exact learning plan and use it somewhere else; professionals must sit down, scan the environment, and see what is going on and what needs to be accomplished.

The team ended up creating Moderna University from a case study, which was developed as an intersection of a physical campus, digital platform, industry learning center, and cultural hub. The other case study Ogbuchiekwe described went into a modern twist of a risk assessment, which is a “frame-by-frame” model with risk profile-based training curriculum. “People deserve training experiences that are aligned with what we know about how adults learn best- interactive, incorporate different ways of learning,” she said. These types of learning changes save time, create no misalignments within the organization, and can bring back collaboration and more valuable items for employees.

For King at AstraZeneca, a major issue that the organization has seen is going through new employee orientation and assigned standard operating procedures (SOPs) just to “check a box” and end up burning out. These types of onboarding activities with no context do not equal competency, understanding, or confidence, according to King, which AstraZeneca aimed to solve. Something King learned is to always demand to know the reason for the requirement for a training. “Whenever I go in somewhere and I ask to do something, sometimes a minor change, sometimes a more radical change, I always ask, ‘what is the requirement?’,” she explained.

After implementing this, one can discuss about how they interpret the requirement and what is best for the patient or organization, since this gives anyone the opportunity to reset any regulation that exists, according to King. AstraZeneca, for example, is participating in the GMP Education & Training Uplift Project (GETUP) which is fundamental in terms of how someone is trained. The manager can decide which asset is needed for an employee and then that person is trained on that solely, while SOPs are organized to be accessed at any time but not necessary in everyday training. King also described how AstraZeneca is set on creating a universal set of requirements, which is one global SOP that everyone can follow to avoid extra documentations and other iterations of the same documents.

“I know we sit in offices sometimes and we know how things are, we base it on our experience maybe 6, 7, 10, 15 years ago … please go see. Please go see your employees and ask what they remember, what’s been effective and what’s not, and start asking people ‘show me the requirement,’” King said. Additionally, being a champion for change with those who are open minded and gathering as much data as possible can also be beneficial to creating a successful learning community.

King, N; Ogbuchiekwe, N. Innovations in CGMP Training. Presentation at the 2023 PDA/FDA Joint Regulatory Conference, Washington, DC, Sept. 18–20, 2023.

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Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference. 

Being Innovative in CGMP Training While Adapting to Change 

In part of the session "Continuous Manufacturing and Publication of ICH Q13" at the PDA/FDA Joint Regulatory Conference, Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

 Perceived barriers to continuous manufacturing have been falling one by one. ICH Q13 facilitates adoption of continuous manufacturing. By providing common language and a framework of fundamentals of a continuous manufacturing. I see as an accelerator, rather than an endpoint, the evolution of pharmaceutical quality over the last several decades. With adoption of risk based approaches, process analytical Technology and Quality by design have set the stage for adoption of continuous manufacturing. The concepts of process dynamics and system integration from multiple connected human operations are newer for the pharmaceutical industry. However, while newer to the pharmaceutical industry, continuous manufacturing has been the norm and other industries, such as petroleum refining for over 100 years. The FDA encourages industry to adopt and implement continuous manufacturing. The FDA Emerging Technology Team, created in 2014 allows for additional engagement and interaction with the agency to help industry adopt new technologies such as continuous manufacturing. There are about 14 FDA approved drugs that include continuous manufacturing elements. The first drug approved with continuous manufacturing elements was in 2015, followed by the first approval for switch from batch to continuous manufacturing in 2016. The first biotechnology or protein therapeutic drug with continuous manufacturing LMS was approved in 2020. 2022 saw the publication of ICH Q13 and the internationally harmonized guidance on continuous manufacturing. That same year, there was an FDA publication, which showed that the approval times for products with continuous manufacturing elements was actually faster than that for similar products using batch manufacturing. In summary, guidance from the FDA and the ICH had been published. There have been approvals for both small and large molecule drugs. There are FDA programs such as the emergent technology program designed to foster early engagement and collaboration. And certainly not least, the analysis has shown that approval timelines for continuous manufacturing are not longer than those for similar products produced with the batch operation.

Videos

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

Barriers to the Development of Continuous Manufacturing and ICH Q13 (PDA/FDA Joint Regulatory Conference 2023)

In his part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies" at the PDA/FDA Joint Regulatory Conference 2023, Michel Sadelain, MD, PhD, Director, Center for Cell Engineering; Stephen and Barbara Friedman Chair, Memorial Sloan Kettering Cancer Center,

discusses CAR-T cells and living drugs for immunotherapy. 

 Really, hurdles stemmed from the fact that this was an untested and unproven technology in the clinical realm. And also in the pharmaceutical industry. The medicine here, the drug, is not a chemical or a small molecule. It's not even a protein. It's a cell. And on until recently, cells have never been approved as drugs. On top of that, these are not just cells, human cells, but they're genetically engineered cells. And as you may recall, back a few decades ago, there was a lot of concern, and even fear that genetic engineering could prove to be harmful in some ways. So this, so developing this approach did indeed go against the grain of many received ideas back in the 90s. But we now see that all that changed with the first approvals of CAR-T cells approvals by the US FDA, back in 2017. 

The term living drugs is a term I actually introduced in an interview to the New York Times a little over 10 years ago when explaining what a CAR-T cell is to the reporter. CAR-T cells make use of a synthetic receptor for antigen, which is what we named A chimeric antigen, sorry, which is what we named primerica antigen receptor or CAR. That instructs the T cell to recognize an antigen of our choosing, and to further have the T cell to do something about it, which means to kill the tumor cell. And not only that, it also tells the T cell to multiply. And so this is a medicine that multiplies that expands the numbers in the body of the patient. And it also makes use of viral vectors to introduce the gene coding for the synthetic receptor into those T cells. So in that context, it seemed like one way of summarizing it was to describe these as living drugs. 

 A round of CAR-T cells first, what we see today is the approval of already six different products for them for different refractory B cell malignancies, and two of them for refractory, multiple myeloma. As we all know, there hasn't yet been success and solid tumors. And many groups though, and many in academia and in industry, are currently pursuing the goal of adapting this very powerful technology to those solid tumors. What I think is equally interesting, though, is to see today CAR-T cells being investigated beyond cancer. And there have been very recent reports of remarkable early results in forms of autoimmune disorders, in particular, systemic lupus erythematosus. This makes use of the exact same CAR-T cells that have been developed for B cell malignancies targeting this antigen that we anti identified many years ago called CD19, but put to use in patients with autoimmunity. I think it's fair to say that this is triggering widespread enthusiasm today to explore CAR-T cells and a range of autoimmune disorders. And CAR-T cells could also be useful in intractable infections or different settings of transplantation. Now, beyond CAR-T cells, cell and gene therapies are today really coming of age. After a good three decades of exploring different vector systems, devising different manufacturing schemes, I think it's fair to say that a number of ex vivo and in vivo genetic engineering strategies are showing, are starting to show real results for patients. So I think we have to expect more and more of these coming to the fore.

Part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies," Sadelain discusses CAR-T cells for immunotherapy and the future of cell/gene therapies.

Living Drugs for Immunotherapy (PDA/FDA Joint Regulatory Conference 2023)

Stuart Malcolm, head of Standards, Efficiency, and Automation at Veramed, spoke with Grant Playter, associate editor, on-site at the REV4 data conference in New York City. Stuart spoke at length on the intersection of statistical programming and clinical trials and how the industry plans to leverage data, automation, visualization, and artificial intelligence technologies going forward.

Stuart Malcolm, head of Standards, Efficiency, and Automation at Veramed, speaks on how advancing technologies are shaping clinical trials.

How Breakthrough Technologies are Shaping Clinical Trials with Stuart Malcolm

CPHI, a pharmaceutical conference covering everything in the pharma spectrum from ingredients to packaging, announced on August 15, 2023 that it would be returning to Milan, Italy in 2024. The global pharma exhibition will be hosted at the Fiera Milano from October 8-10, 2024.

According to a press release from Informa, the event organizers, the 2024 event is expected to see record attendance due to a large number of international visitors and a rapid increase in attendees from major Asian pharma hubs. The event was previously held at this location for CPHI 2022.

“We are delighted to be returning to Fiera Milano, as Italy and the Lombardy region are widely known as one of the key pharma manufacturing centers in Europe,” said Adam Anderson, executive vice-president, Pharma, at Informa. “There are very few global locations with such a depth and breadth of local and regional talent. We expect a large international attendance and will marry this with local and regional manufacturing insights. I am excited to bring CPHI … back together with the industry in Milan.”

“Fiera Milano is the ideal venue for a global event like CPHI, which is an important tenet of this industry and central to the world economy, with the Lombardy region being a leading producer of pharmaceuticals,” said Roberto Foresti, deputy general manager of Fiera Milano, in the release. “What makes Milan so attractive is that the city has world-class infrastructure and is well connected to European, Asian, and North American countries. It’s why Fiera Milano continues to attract massive international events.”

CPHI 2024 will return to the Fiera Milano in Milan, Italy.

CPHI to Return to Milan in 2024

Caroline Phares, global head of Health and Life Sciences at Domino Data Lab, speaks with Grant Playter, associate editor, on integrating data processes into pharma operations. Topics of discussion include trusted research environments, the proper balance between data accessibility and privacy, how pharma will use artificial intelligence in the future, and more.

For more from Caroline, we encourage you to read her piece on interoperability difficulties stemming from the skills gap within statistical programming organizations. The piece can be read in full 

Caroline Phares, global head of Health and Life Sciences at Domino Data Lab, speaks on integrating data processes into pharma operations.


Diving into Data Integration with Caroline Phares

The INTERPHEX Exhibitor Awards recognized several parenteral packaging and handling advancements at INTERPHEX 2023, which took place between April 24–26, 2023 at the Javits Center in New York, NY (1). The Best in Show award went to IMA Life North America for its INJECTA aseptic fill/finish system, which has evolved to integrate its gloveless module. Robotic technologies help achieve gloveless processing and eliminate human intervention at crucial stages of the process, such as the aseptic assembly of sterile components loaded using rapid transfer ports. The system does not lose the sterility guaranteed by the autoclave, does not come into contact with the operator, and is assembled entirely in aseptic conditions following isolator decontamination. The extensive use of robotics drastically reduces the number of manual operations, eliminating the need for productivity-sapping integrity checks and simplifying compliance with Annex 1, which views gloves and manual operations as major sources of contamination (2).

The award for Best New Product/Service went to the BoMa Dosing System from DEC Group, which recently established a Filling Solution Technologies Division. Judges selected the patented BoMa precision filling technology for its ability to precisely dose highly sensitive pharmaceutical products without the stress and shear associated with pumps and other conventional filling methods. The system harnesses the physics principles of Boyle’s Law, or pressure and volume of a gas have an inverse relationship with constant temperature, and uses a vacuum to smoothly and precisely handle tiny amounts of product and a wide range of fluid densities and viscosities (3).

A robotic innovation, the bionically-inspired, energy-free ADHESO gripping technology from Schunk, captured the Editor’s Choice award. ADHESO end effectors grip without mechanical force, external energy supply, or residue generation enabling gentle product handling and compatibility with cleanroom requirements. Modeled on Van Der Waals adhesive forces used by animals, such as geckos, for locomotion, the grippers use gentle pressure to pick and one of four release options for placing: rotary movement, tilting movement, sliding movement, or pressing. Alternatively, it is also possible to equip the gripper with an active wiper, which prevents mechanical stress on the workpiece at the placing position. Four standardized ADHESO gripper pad sizes with matching ISO flange adapter serve a wide range of applications (4).

The Ready Pack system from West Pharmaceutical Services earned the Best Technologies award. The ready-to-use sterile packaging system provides all the components needed to fill/finish sterile products, including sterilized NovaPure stoppers, Flip-OffCCS (clean, certified, sterilized) seals, and Corning Valor ready-to-use vials utilizing Stevanato Group's EZ-fill tray or nest and tray formats. Available from stock in small order quantities, Ready Pack kits are particularly well-suited for R&D purposes or small filling operations and designed to support a smooth transition from early-stage pilot manufacture to larger commercial-scale operations and accelerate speed to market (5, 6).

West Pharmaceutical Services, which is celebrating its 100th anniversary, also took home honors for two poster sessions, a Third Place for Evolving Component Technologies to Meet the Needs of Large Volume Injections and a Fifth Place for Functional Assessment of Adeno-Associated Virus Stored in Daikyo Crystal Zenith Vials at Ultra-cold Temperatures(1). 

INTERPHEX 2024 will return to the Javits Center on April 16–18, 2024 (1).

1 RX (Reed Exhibitions). Pharmaceutical Manufacturing and Biotech Industries Showcase Latest Innovations throughout INTERPHEX 2023. Press Release. May 4, 2023.

2 IMA Life. IMA Life Wins Top Prize at INTERPHEX New York 2023. 

3 Dec Group. DEC Group Wins INTERPHEX Award for BoMa Filling Solution. 

5 West Pharmaceutical Services. West's Ready Pack™ Containment Solution with Corning® Valor® RTU Vials Utilizing Stevanato Group's EZ-fill® Technology Recognized for Best Technologies Award at INTERPHEX. Press Release. May 2, 2023.

6 West Pharmaceutical Services. West Ready Pack, Product Sheet. January 2023.

INTERPHEX

Parenteral packaging and handling advancements receive awards.

INTERPHEX 2023 Honors Packaging Innovations

Geert Moens, Global Platform Leader Vial Closure Systems, Datwyler Healthcare, speaks with Grant Playter, associate editor, on recent technologies in the film and spray coatings market. 

Filmed shortly after the INTERPHEX conference, Geert discusses the rise of prefilled syringes, the larger state of the paranterals and drug packaging markets, and his company's latest film coating solution, which was launched during the conference.

Geert Moens, Global Platform Leader Vial Closure Systems, Datwyler Healthcare, discusses recent technologies in the film and spray coatings market.

Discussing Film and Spray Coatings with Geert Moens (INTERPHEX 2023)

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 

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. 

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