Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

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Sanofi’s consumer healthcare business unit launched the Open Innovation Portal on June 14, 2023. According to a company press release, the intent of this portal is to allow the wider pharma supply chain community—including start-ups, entrepreneurs, research institutions, and more—to submit potential solutions for the consumer healthcare landscape. Persons/entities with successful submissions will be given the opportunity to work as collaborative partners on projects with the consumer healthcare unit at Sanofi.

Current challenge areas that have been identified for the program include sustainable packaging and novel products and technologies. According to the release, the company plans to add new challenges in the areas of digestive wellness, cough, cold & flu, physical & mental wellness, allergy, pain care, personal care, and sustainability.

“A problem shared is a problem halved and the Open Innovation Portal is part of our mission to unlock science to bring health in the hands of millions of consumers and patients,” said Josephine Fubara, chief science officer, Consumer Healthcare, Sanofi. “The Open Innovation Portal will also serve as an opportunity to partner with the brightest and the best to bring some truly transformative ideas to life for our consumers.”

Articles

Sanofi’s Open Innovation Portal is designed to promote community feedback and propose novel solutions to various problems in the healthcare landscape.

Sanofi Consumer Healthcare Opens Suggestion Portal

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Contract development and manufacturing organization (CDMO) Aenova has opened a new building for the production of highly potent APIs at its Regensburg site in Germany, it was announced in a June 23, 2023 press release.

With this investment, worth a total of €25 million, Aenova will be able to increase its development and production capacities for cytotoxics and cytostatics and meet the growing market demand for these ingredients. The new building comprises four stories with a total building area of more than 4000 m

 and includes production and packaging facilities for highly potent tablets along with associated laboratories, development, storage, and social rooms.

“Producing billions of tablets and capsules each year, Aenova is a partner of choice for novel product solutions as well as commercial high-volume manufacturing,” said Oliver Schmied, managing director at the Aenova site in Regensburg, in the press release. “A particularly unique selling point is that we offer production flexibility using harmonized production equipment, enabling small to large batches from 0.5 to 500 kg for development, [clinical trial materials], scale up, and commercial batches.”

“Within the overall investments of the Aenova Group, the new building for highly potent APIs in Regensburg is an essential strategic building block,” added Jan Kengelbach, CEO of the Aenova Group, in the press release. “As a development and manufacturing partner, we are thus a reliable and agile CDMO for our customers in the promising market segment of highly potent active ingredients.”

Aenova has opened a new building for the production of highly potent APIs in Germany.

Aenova Opens New Building for Highly Potent Drugs

Sandbox AQ, an enterprise software-as-a-service company, announced the formal launch of its biopharma molecular simulation division, AQBioSim on June 22, 2023. According to a company press release, the division is working with companies like AstraZeneca, Sanofi, and the University of California, San Francisco (USCF) on treatments for cancer, Alzheimer’s, Parkinson’s, and other conditions.

“We are very interested in the work SandboxAQ is doing to revolutionize drug discovery and development via 

 simulation of molecular interactions using [artificial intelligence] and quantum technologies,” said Paul Hudson, CEO, Sanofi, in the release.“SandboxAQ’s leapfrog technology could significantly impact both preclinical and clinical development of drugs, and we look forward to seeing how it could support us in delivering life-changing treatments to patients worldwide, faster.”

According to the release, the company’s molecular simulation division is designed to improve on existing methods via faster time-to-solution while still retaining accuracy. The technologies use AI-powered simulation to rapidly identify potential therapies for various conditions; for example, the company’s collaboration with the USCF used the proprietary Absolute Free Energy Perturbation software to generate thousands of predictions of molecular interactions. This was done to develop new compounds for use in potential therapies for neurodegenerative disorders.

“Neurodegenerative diseases are enormously complex and defy standard drug design,” said Stanley B. Prusiner, director, UCSF Institute for Neurodegenerative Diseases, in the release. “We need rational and structure-based design methods that can address the challenging diseases we face. Given the devastating nature of these diseases and the lack of effective therapies to treat them, techniques that accelerate new leads and reduce our discovery timelines are greatly needed.”

Sandbox AQ’s molecular simulation division is collaborating with companies like AstraZeneca and Sanofi to develop novel treatments for various disorders.

SandboxAQ Launches Molecular Simulation Division

FDA published guidance on June 13, 2023 providing recommendations for industry and review staff on the formal disagreement resolution and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that are subject to a final administrative order under section 505G of the Food, Drug, and Cosmetic Act.

According to the guidance, nonprescription drugs are covered without approved new drug applications, which are governed by the provisions of section 505G. Additionally, the guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

The guidance outlines the procedures for an administrative hearing related to a final order and describes the procedures for consolidated proceedings for FDR and hearings to resolve scientific and/or medical disputes related to final orders.

The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act

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)

Feliza Mirasol is the science editor for 

On June 22, 2023, Andelyn Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization, announced the opening of its newly constructed manufacturing headquarters in Columbus, Ohio. According to a company press release, the 180,000-ft2 facility is intended to complement Andelyn’s two existing facilities in Columbus.

The new facility houses laboratory and manufacturing space, is regulatory-compliant, and more than triples Andelyn’s footprint to meet the growing demand for CGT services.

“The new facility includes 16 [C]GMP [current good manufacturing practice] modular manufacturing suites with upstream, downstream, solution prep, and filling capabilities, along with quality control labs and warehouse and corporate headquarters space,” said Wade Macedone, CEO, Andelyn Biosciences, in a company press release. “We are proud of our record of success in this demanding field, with over 2000 viral vector production runs and more than 450 [C]GMP batches delivered in support of more than 75 global gene therapy clinical trials.”

The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.

Andelyn Biosciences Opens New CGT Manufacturing Headquarters

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 15, 2023 to discuss and make recommendations for updated COVID-19 vaccines for use in the United States in autumn of 2023. The committee unanimously voted that the vaccine composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant.

At the meeting, VRBPAC reviewed available data on the circulation of various SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, animal immunogenicity data generated by new candidate vaccines expression or containing updated spike components, and preliminary human immunogenicity data generated by one XBB.1.5 vaccine candidate. The committee was also informed of current manufacturing timelines.

Based on the provided evidence, FDA ultimately advised manufacturers planning to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. FDA plans to continue monitoring the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus.

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA Releases Updated COVID-19 Vaccine Guidelines

On June 20, 2023, FDA announced a new voluntary pilot program for certain oncology drug products used with certain corresponding 

 diagnostic tests. The goal of this program is to help clinicians select appropriate cancer treatments for patients.

 companion diagnostic test is one that provides information needed for the safe and effective use of a corresponding treatment. In certain limited circumstances, FDA may decide to approve a life-saving treatment that requires an 

 companion diagnostic even if a corresponding 

 companion diagnostic has not yet received marketing authorization. In these situations, laboratory developed tests (LDTs) are being used for patient treatment decisions, but these are not generally reviewed by the agency for safety or effectiveness.

The new pilot program hopes to address concerns that LDTs do not provide accurate or reliable test results, according to an agency press release. FDA will request drug manufacturers to provide performance information for the tests used to enroll patients into the clinical trials that support drug approval. Following assessment of that information, FDA will publish minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug. In doing this, laboratories may use this information to guide LDT development to identify specific biomarkers used for selecting cancer treatment. According to the release, this transparency aims to help facilitate better and more consistent test performance, ultimately resulting in better drug selection and improved care for cancer patients.

“We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory developed tests,” said Jeff Shuren, director, Center for Devices and Radiological Health, FDA, in the release. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”

The initial phase of the pilot program is intended to last up to one year. FDA will evaluate no more than nine drug sponsors for possible acceptance into the pilot. The minimum recommended performance characteristics for 

 diagnostic tests used with each approved drug product under the pilot—based on the clinical trial assays—will be made publicly available on the FDA website following drug approval.

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk

The Public Investment Fund (PIF), Saudi Arabia’s global investment organization, announced on June 18, 2023 that it has launched Lifera, a commercial-scale contract development and manufacturing organization (CDMO). The CDMO will enable growth of the local bio/pharmaceutical industry, strengthen national resilience, and support Saudi Arabia’s position as a global pharmaceutical manufacturing destination.

Lifera will focus on the manufacture of essential biopharmaceutical products, including insulins, vaccines, plasma therapeutics, monoclonal antibodies, cell and gene therapies, and innovative small molecules. The company will also create partnerships with leading local and international companies as well as attract targeted investments in a bid to grow local capacity and strengthen domestic manufacturing in this sector.

A part of Lifera’s goals is to drive formulation development, medicine development, and manufacturing. The company also intends to increase testing services for sterile bio/pharmaceutical products.

“PIF is investing to enable a leading health sector in Saudi Arabia, supporting the development of and access to advanced medicines and treatments. Biologics represents one of the most critical and fastest-growing pharmaceutical segments, both in Saudi Arabia and globally,” said Yazeed A. Al-Humied, deputy governor and head of Middle East and North Africa (MENA) Investments at PIF, in a company press release. “Lifera intends to partner with leading companies in the sector to localize manufacturing, attract investment, and enable the private sector to scale up, ensuring easier access for patients, whilst securing supply of life-saving medicines that can meet local, regional, and global demand.”

PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.

Saudi Arabia’ PIF Launches Lifera, a New CDMO

Choose New Jersey, a nonprofit economic development organization for the state of New Jersey, announced on June 15, 2023 that Enzene Biosciences, a Pune, India-based biotech company will invest $50 million to open a new biopharmaceutical manufacturing plant on the Princeton West Innovation Campus in Hopewell, NJ. The facility is expected to start up in June 2024 and is the company’s first location outside of India, according to a press release issued by the nonprofit.

Enzene is a contract development and manufacturing organization and a subsidiary of Alkem Laboratories, an Indian pharmaceutical company. As part its expansion plans, Enzene will initially hire 50 employees and grow to 300 employees at the New Jersey facility.

The placement of the facility is intended to provide North American biopharmaceutical companies with streamlined supply chains, quick turnaround times, enhanced communication, and greater control over the manufacturing process, according to the press release. Enzene expects to support the development and production of a diverse range of biologics at the facility.

“The strong relationship between New Jersey and India has gained increasing momentum since we opened the New Jersey India Center to cultivate economic opportunities during our trip to the country in 2019,” said NJ Governor Phil Murphy, in the press release. “I am proud to welcome Enzene Biosciences and their expanding global presence to New Jersey’s flourishing life sciences industry. New Jersey’s favorable business environment, skilled workforce, strategic location, supportive ecosystem for growth, and deep cultural ties are why Indian companies thrive in our state.”

“Enzene Biosciences is thrilled to establish our manufacturing operations in New Jersey, as it allows us to extend our local manufacturing capabilities to our valued North American clients,” said Himanshu Gadgil, CEO of Enzene Biosciences, in the release. “We are excited to provide them with access to our cutting-edge continuous manufacturing platform, which enables streamlined and efficient production processes. New Jersey’s highly skilled workforce, state-of-the-art infrastructure, and renowned academic institutions make it an ideal location for Enzene, ensuring that we can deliver exceptional services and support to our clients in the [United States].”

India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.

Featured Content

Behind the Headlines Episode 27

Ask the Expert

Drug Digest September 2025

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

Top Trends Reshaping Pharma R&D