Behind the Headlines Episode 27

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

Drug Digest September 2025

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Charles River Laboratories, a pharmaceutical company specializing in cell and gene therapies, announced the launch of its lentiviral vector (LVV) packaging plasmids on June 13, 2023. According to a company press release, the immediate availability of these off-the-shelf plasmids is intended to provide a streamlined solution for challenges associated with plasmid sourcing for cell and gene therapies, including capacity bottlenecks, timeline pressures, and process development optimization.

“We are thrilled to announce this addition to our product offering,” said Kerstin Dolph, corporate senior vice-president, Biologics Solutions, Charles River, in the release. “Our LVV packaging plasmids allow us to further support advanced therapy programs and most importantly, help expedite the delivery of safe, effective therapies to those who need them most."

“Charles River’s LVV packaging plasmids offer researchers and manufacturers a high-quality, reliable tool to support their LVV viral vectors production,” said Andrew Frazer, associate director, Scientific Solutions, Charles River, in the release. “The new plasmids will be a valuable resource to develop new treatments for a wide range of programs in preclinical and clinical development with the continuity of supply for commercial use”

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Charles River’s off-the-shelf lentiviral vector packaging plasmids are intended for use with cell and gene therapies.


Charles River Laboratories Launches LVV Packaging Plasmids

Novo Nordisk announced on June 12, 2023, that the company plans to invest 15.9 billion Danish kroner starting in 2023 to further expand an existing API production facility in Denmark. The investment, which is taking place in Hillerød, Denmark, will aim to create more production capacity and increase the company’s ability to meet future market demands and to continue development on its future clinical late-phase product portfolio.

“This important investment will ensure the continuous development of our late-phase pipeline into deliveries of important medicines for treatments to patients worldwide,” said Henrik Wulff, executive vice president of Product Supply, Quality & IT, in a press release. “The investment announced today confirms Hillerød and Denmark as cornerstones in our global footprint, and I would like to take this opportunity to thank the Danish Government and Parliament for their continued focus on ensuring good and stable infrastructure and supplies—allowing us to continue to expand our production capacity to the benefit of patients living with serious chronic diseases.”

The 65,000-square-meter facility is going to be designed as a multi-product facility, with maximum flexibility to accommodate new processes and displaying state-of-the-art technology and working environment, according to the press release. Novo Nordisk will be designing optimal and compact process flows to allow a substantial reduction of water and energy consumption to accomplish this.

Novo Nordisk’s facility is expected to start producing API by early 2029, and it is hopeful to create 340 new jobs when construction is completed. The facility is also fully equipped.

The investment, which is taking place in Hillerød, Denmark, will aim to create more production capacity and increase the company’s ability to meet future market demands and to continue development on its future clinical late-phase product portfolio.

Novo Nordisk to Expand Manufacturing Facilities in Hillerød, Denmark

AstraZeneca announced an exclusive option and license agreement with Quell Therapeutics, a UK-based biotechnology company, on June 9th, 2023. Per the terms of the agreement, Quell will develop T-regulatory (Treg) cell therapies for Type 1 diabetes (T1D) and inflammatory bowel disease. According to a company press release, AstraZeneca will pay Quell $85 million upfront for the rights to these treatments, but Quell’s total payout could come to more than $2 billion plus tiered royalties if various development and commercialization milestones are met.

“We are extremely pleased to have AstraZeneca on board as our first major partner,” said Iain McGill, CEO, Quell Therapeutics, in the release. “This collaboration builds on our pioneering work to develop exquisitely engineered, multi-modular Treg cell therapies for immune disorders and provides excellent validation for the technologies and capabilities we have established. We are proud and incredibly excited to partner our leading science with the deep experience of AstraZeneca to accelerate the application of our Treg cell therapy platform in major autoimmune disease, where we believe there is a broad opportunity to reset immune tolerance and drive durable responses for patients.”

“This is a very exciting collaboration with Quell as we look to expand our next-generation therapeutic toolbox and explore the untapped potential with Treg cell therapies in autoimmune indications,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca, in the release. “This is aligned with our strategy to target underlying disease drivers to stop or slow disease progression and ultimately accelerate the delivery of transformative care to patients with chronic autoimmune conditions.”

In addition to the previously disclosed terms, Quell retains an option to co-develop Treg cell therapies from the T1D program with AstraZeneca in the United States in exchange for additional milestone payments and increased royalties on US net sales. This can be exercised either after approval of an Investigational New Drug application or at the end of the Phase I/II clinical study.

The deal, valued at more than $2 billion dollars, will see Quell Therapeutics develop various T-regulatory cell therapies for AstraZeneca.

AstraZeneca and Quell Therapeutics Strike Cell Therapy Development Deal

Croda Pharma, a biopharmaceutical excipients, vaccine adjuvants, and lipids provider, recently broke ground on its newest manufacturing facility in Lamar, Pa. The 23,680 ft² excipients facility will manufacture ingredients for drug delivery systems used in novel therapeutic drugs, including mRNA vaccines and gene editing therapies. It will also support production of lipids that are already used in therapeutics and vaccines, as well as “next-generation” therapeutics that are currently being developed, such as lipids for novel cancer treatments. The new facility will begin construction this year and is expected to be completed in 2025.

“There are rare moments that a team can contribute to such a significant betterment of humankind,” said Bradley Cook, vice-president, North American Operations, Croda, in a May 31, 2023, press release. “The on-going collaboration with the Department of Health and Human Services and its premier biomedical countermeasure development agency, BARDA, has afforded Croda and this team the opportunity and we are extremely excited and proud.”

The new excipients manufacturing facility is expected to be completed in 2025.

Croda Pharma Breaks Ground on Excipients Manufacturing Facility

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Chris Spivey, editorial director, speaks with Sean Hart, CEO and SCO of LumaCyte, on percent transduction for AAV measured. The full discussion can and more can be viewed 

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Chris Spivey, editorial director, speaks with Sean Hart, CEO and SCO of LumaCyte, on percent transduction for AAV measured.

Transduction for AAV with Sean Hart

Chinook Therapeutics, Inc. announced on June 12, 2023 that it has entered into an agreement and a merger plan with Novartis AG where Novartis will acquire Chinook for $40 per share in cash, for a total of $3.2 billion. Additionally, Chinook shareholders will receive contingent value rights providing for payment of up to $4 per share upon the achievement of certain future regulatory milestones, according to the company press release.

“We are pleased that Novartis recognizes the significant value that the Chinook team has built with our pipeline of clinical and preclinical programs for patients with rare, severe chronic kidney diseases,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics, in a press release. “We believe this transaction is great news for kidney disease patients and the programs we have built at Chinook. Through this merger, Novartis can apply its substantial resources to pursue broader development efforts and commercialization of atrasentan, zigakibart (BION-1301), and other programs in our pipeline to build its global renal therapeutic area.”

The merger agreement states that Novartis will acquire all the shares of Chinook through a subsidiary for a price of $40 per share in cash at closing. Further, the completion of the transaction is expected in the second half of 2023 and is pending approval by Chinook’s stockholders and the satisfaction of other customary closing conditions.

The merger agreement states that Novartis will acquire all the shares of Chinook through a subsidiary for a price of $40 per share in cash at closing.

Chinook Therapeutics Acquired by Novartis AG

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

Corning Pharmaceutical Technologies announced its Velocity Vials Technology Platform on June 8, 2023 to increase access to Corning’s Velocity Vial technology. This will allow industry leaders to make and sell the product, in addition to providing more choice to pharma and biotech companies.

According to the company press release, Corning will expand its manufacturing footprint, localize its supply chains, and enable the purchase of Velocity Vials through a network of selling partners. The new partnership with Gerresheimer AG will combine Gerresheimer’s extensive glass converting expertise with Corning’s innovative external vial coating technology, which helps with co-manufacturing and selling Velocity Vials.

Shortly after, SGD Pharma joined and announced a joint venture with Corning that includes the opening of a new glass tubing facility and expanded access to Velocity Vial technology in India. Further, Velocity Vials are important to the global distribution of essential vaccines and medications during the COVID-19 pandemic, according to the company.

“We are starting to see a paradigm shift in the pharmaceutical primary-packing industry, where coated vials are becoming the new industry standard,” said Brendan Mosher, vice president and general manager, Corning Pharmaceutical Technologies, in a press release. “Velocity Vials have demonstrated immediate benefits for our customers. The adoption of the technology by leading pharmaceutical-packaging providers is yet another proof point of this evolution.”

Velocity Vials can improve filling-line efficiency by up to 50%, which lowers costs while also improving the quality. It can also reduce the likelihood of damage that leads to cracks, breaks, and cosmetic defects. The vials are made with Type 1 borosilicate glass and conform to ISO standard dimensions, and they can be dropped-in to existing operations with no significant changes or reporting to regulatory authorities, according to the company press release.

This will allow industry leaders to make and sell the product, in addition to providing more choice to pharma and biotech companies.

New Velocity Vials Technology Platform to Expand Industry Partnerships

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

On June 8th, at the Bio conference in Boston, Samsung Biologics announced a long-term agreement with Pfizer that enlarges and extends a March $183M manufacturing deal between the two. This strategic collaboration will focus on long-term biosimilars manufacturing, and more specifically for the Pfizer biosimilars portfolio group; the agreement is estimated at an initial $411 million, according to 

 by the CDMO. To get to this point Samsung appears to have leveraged positive word of mouth from its partnership to produce COVID-19 vaccine material for Moderna.

According to a company press release, Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology. Samsung will use its newest facility, Plant 4, for the manufacturing.

“We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe,” said John Rim, president and CEO, Samsung Biologics, in the release. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had previously committed and are on the move for future expansion into our second campus in order to provide our clients with even more flexible and advanced manufacturing technology.”

“Our collaboration with Samsung Biologics will have the potential to significantly improve the lives of patients globally,” added Dong-Wook Oh, country manager, Pfizer Korea.

With the blockbuster Humira now open to biosimilar competition, that production application seems likely to be an early target. However, while biosimilar introductions have not drastically reduced prices as originally hoped, at least 

 Humira biosimilars are expected over the next few months and some could debut with heavily discounted prices. This includes Amgen’s Amjevita, Samsung’s [partnering with Bioepis/organon] Hadima, and Pfizer’s Abrilada. AbbVie has made 

Samsung biologics also announced that the company will start operating its fifth plant in April 2025, five months earlier than its original schedule, in order to meet a rush of orders from global big pharma companies. Upon the plant's full completion, the company will have a biomanufacturing capacity totaling 

 of finalized terms from July 3, 2023, disclosed that the two deals to manufacture Pfizer's multiproduct biosimilar portfolio are now worth a combined $897 million. The finalized terms on the June deal indicate that it alone is now worth approximately $704 million, making it the single-largest contract granted to Samsung Biologics. As of this latest update, the company has inked deals worth approximately $1.5 billion in 2023.

The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.

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