signed a six-year, $1.4 billion contract manufacturing agreement

 with an as-yet undisclosed European pharmaceutical company, with production to take place at Samsung’s manufacturing site in Songdo, South Korea (1). Simultaneously, at the J.P. Morgan Healthcare Conference held in San Francisco, the company announced plans to complete construction of its fifth biomanufacturing plant, housed on a new campus—both scheduled to open in April 2025—and said it was considering construction of a sixth plant in response to growing market demands (2).

Even with its newly minted pharma partnership in hand, Samsung said the fifth plant would raise its global biomanufacturing capacity by 180,000 L to a total of 784,000 L, and the sixth plant would push that figure to 964,000 L. Such is the crunch that companies are feeling early in 2025 when it comes to capacity concerns and drug shortages these companies are trying to quickly and efficiently address.

John McQuaid, president and managing director of Almac Pharma Services, summarized just a few of those concerns 

“There's never been a larger number of molecules in clinical development, and we're certainly seeing that increasing demand,” McQuaid said in the interview (3). “We've got demand in areas such as [highly] potent [APIs], [and] age-appropriate formulations, such as pediatrics. We've got poorly soluble compounds, and the need for technologies to address that. And then we've got personalized medicines, such as, … cell and gene therapies, which drive particular needs in areas such as fill/finish and cold chain requirements.”

McQuaid added that the rise of glucagon-like peptide-1 (GLP-1) drugs are especially driving demand and, accordingly, stress about the supply chain.

As explained by Kevin Li, MBA, chief marketing officer at BioDuro-Sundia, 

 outsourcing strategy can take one of two paths: a “traditional” approach in which a bio/pharmaceutical company splits up its program and partners with one or more contract development and manufacturing organizations (CDMOs) and a separate contract research organization (CRO), or an integrated model—which can be looked at as either horizontal, with a partner providing services from discovery to development and commercial manufacturing, or vertical, integrating medicinal chemistry, biology, and drug metabolism and pharmacokinetics starting with the discovery phase into development (4).

“One side can handle both drug substance and drug product, and one side can handle the pre-formulation, formulation development, until commercial manufacturing, everything in one side,” Li told 

®. “It's very difficult and time-consuming to manage multiple vendors, and if you do integrate the program with one vendor ... that's much easier, simpler to manage the process to avoid any potential interruptions.”

, which was fully released at CPHI Milan, suggested that 

trends may shift dramatically by the beginning of 2028

 (5). The report said contract manufacturing organizations (CMOs) and hybrid companies, which have their own pipelines and contract services for using spare capacity, will grow to hold 54% of global biologics capacity within the next three years beginning with 2025. Capacity for new clinical products entering development, according to the report, may not be easily accessible in the United States—despite capacity being available—and Europe and Asia may account for up to 75% of all CMO resources available by 2028.

“We see many more biotechs and early-stage companies now attending [CPHI Europe] to find suitable capacity—particularly for small production runs where they are more likely to partner with one of the hundreds of smaller CDMO partners. Helping find these ‘perfect fits’ is vital,” said Tara Dougal, Brand & Content director—Pharma, Informa, in a press release announcing the CPHI report (5).

The following is a brief recap of company activity announced in the fourth quarter of 2024 that illustrates some strategic responses to capacity shortage concerns both internally and between partner organizations:

In November 2024, Ascend Advanced Therapies 

announced a partnership with EW Healthcare Partners

 with the intention of expanding capabilities and invest in infrastructure in the US, as a condition of which EW Healthcare’s Advanced BioScience Laboratories (ABL), a biotherapy, oncolytic, and viral vector CDMO in Rockville, Md., became part of Ascend (6). ABL’s facilities provide good manufacturing practice capacity for adeno-associated virus production, and Ascend’s fill/finish capacity in the US is also being expanded.

Also in November 2024, SEKISUI Diagnostics, headquartered in Burlington, Mass., 

completed a £15.7 million (US$20.7 million) expansion of current good manufacturing practice capacity

 at the Maidstone, UK site of its microbial CDMO, BioProduction by SEKISUI (7). “We look forward to working with biopharma companies seeking an experienced partner at a time when demand is outstripping manufacturing capacity,” Robert Schruender, president and CEO of SEKISUI Diagnostics, said in a press release at the time.

Finally, in December 2024, Israel-based biopharmaceutical company Scinai Immunotherapeutics, which develops inflammation and immunology biological products, 

announced the establishment of a US-based subsidiary,

 located in Delaware, for its CDMO services, operating under the same name as its Scinai Bioservices business unit (8). At the same time, Scinai signed its first contract with a US customer, Serpin Pharma of Manassas, Va., to support their clinical manufacturing.

What drugs may be in highest demand by 2028 or 2030 will ultimately drive the strategy of how bio/pharmaceutical companies seek and select outsourcing partners, but for 2025, easing the strain on the supply chain is the foremost priority.

1. Samsung Biologics. Samsung Biologics Signs Manufacturing Deal with Europe-Based Pharma. Fact Sheet. Jan. 13, 2025.
2. Samsung Biologics. Samsung Biologics Presents Business Updates at 2025 J.P. Morgan Healthcare Conference. Press Release. Jan. 15, 2025.
3. Thomas, F. 

CPHI Milan 2024: Pharma Industry Growth and Investment.

CPHI Milan 2024: Highlighting the Benefits of Integrated Services

CMOs and Hybrid Companies Predicted to Hold 54% of Biologics Capacity in 2028, According to CPHI Annual Survey

, Oct. 8, 2024.
6. Ascend. Ascend Advanced Therapies Partners with EW Healthcare Partners to Expand United States Capacity and Capabilities. Press Release. Nov. 12, 2024.
7. SEKISUI Diagnostics. SEKISUI Completes £15.7 Million Expansion in cGMP Biopharma CDMO Capacity. Press Release. Nov. 14, 2024.
8. Scinai Immunotherapeutics. Scinai Immunotherapeutics Establishes US Subsidiary for CDMO Business Unit, Scinai Bioservices Inc. Press Release. Dec. 16, 2024.

When referring to this article, please cite it as Lavery, P. Adopting Flexible Strategies to Combat Capacity Shortages. 

Articles

More and more contract manufacturers have been looking not at what the state of the supply chain is right now, but what it may be in the next three to five years.

Adopting Flexible Strategies to Combat Capacity Shortages

Q: There appear to be a lot of recent changes in the requirements for aseptic processing. Are there any other key developments in this field we should expect in 2025?

A: The two issues that will most likely be top of the list are compliance and competitiveness. Regarding compliance, although Annex 1, the European Union’s guide to the manufacture of sterile products (1), has been in force for over a year, many companies are still somewhat unsure as to how to comply with certain aspects of this document. In particular, establishing the contamination control strategy (CCS) proves to be more complex and resource intensive than many expected (2,3). Creating this document requires access to many disparate sources of information from several departments. Unless this information is accessible electronically, the task will be made excessively difficult.

When it comes to competitiveness, increasing demands from regulatory bodies, including those governing environment and health, place a burden on industry to find solutions (e.g., minimize waste even when using single-use equipment) that do not compromise compliance.

A good source to keep abreast of developing trends is to look at events and activities organized by leading industry associations that traditionally cover aseptic processing; for example, the International Society for Pharmaceutical Engineering (4,5) or the Parenteral Drug Association (6).

These and other organizations (7) are also providing fora for interested parties that prepare guidance documents (e.g., technical reports, good practice guides, points to consider, or similar) from industry experts for industry peers. Active participation in such groups provides early access to these highly valuable documents.

An area of special interest is to bring manufacturing as close as possible to the points of need or care. Rather than shipping product from a central manufacturing hub to a large number of locations, the idea is to establish more manufacturing sites, or even mobile manufacturing units (8) that will bring a lot more flexibility to manufacturing schedules, and deliver resilience to interrupting factors like environmental disasters or new trade barriers. Aseptic processing validation under these circumstances may need careful consideration.

Annex 1 Manufacture of Sterile Medicinal Products, 

Schmitt, S. Contamination Control Strategy–Are We There Yet? 

Schmitt, S. Creating a Contamination Control Strategy. 

ISPE. Building Resilience in ATMP Manufacturing: Insights and Innovations at the 2025 ISPE Aseptic Conference, 

PDA Good Aseptic Manufacturing Conference 2025

Regulatory Affairs Professionals Association. Fundamentals of Pharmaceutical and Biologics Regulations, A Global Perspective. 2nd edition, 

PDA. PDA Points to Consider Mobile Manufacturing, 2025. www.pda.org, [publication planned for 2025].

Siegfried Schmitt, PhD, is vice president, Technical at Parexel.

When referring to this article, please cite it as Schmitt, S. Developments in Aseptic Processing. 

Ask the Expert

Compliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Developments in Aseptic Processing

Technological advances are continuing to push boundaries for global industries. Artificial intelligence (AI) is one such advancement and is being increasingly employed in research and scientific work across multiple disciplines as a result of its ability to improve efficiencies.

A recent example of how AI is improving efficiency at the research stage has been demonstrated by co-scientist, Google’s new AI research tool, which solved a complex problem about superbugs—that had taken microbiologists a decade to work out—in a mere 48 hours (1). Google’s AI tool, built on Gemini 2.0, has been created to help scientists generate novel hypotheses and research proposals, which it does through a combination of specialized agents based on scientific methodology (2).

“The AI co-scientist represents a promising advance toward AI-assisted technologies for scientists to help accelerate discovery,” said Juraj Gottweis, Google Fellow, and Vivek Natarajan, Research Lead, in a blog post (3). “This project illustrates how collaborative and human-centered AI systems might be able to augment human ingenuity and accelerate scientific discovery.”

On the theme of collaboration, earlier this year, in January 2025, accelerated computing company, NVIDIA, announced new partnerships with IQVIA, Illumina, Mayo Clinic, and Arc Institute, to transform the healthcare and life sciences industry with AI (4). Using AI agents, NVIDIA’s partners are seeking to accelerate clinical trials, advance drug discovery, and support industry growth.

Looking a little further along the development lifecycle, towards the larger-scale commercial manufacturing end, the benefits of smarter technology and AI implementation are also being seen. However, as highlighted in this issue’s Focus piece, which can be found on pages 10–13, while technological advances are accelerating progress, there are still hurdles to overcome. “Plenty of challenges stand in the way, including cost of implementation, regulatory compliance, and more. We have heard from experts who anticipate that fully automated, ‘lights-out’ biomanufacturing facilities could become a reality within the next five to 10 years,” explains Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products (5).

Gerken, T. AI Cracks Superbug Problem in Two Days that Took Scientists Years. 

Haigney, S. Google Launches AI Co-Scientist System. 

Gottweis, J.; Natarajan, V. Accelerating Scientific Breakthroughs with AI Co-Scientist. Blog Post. Google Research. Research.google. Feb. 19, 2025.

NVIDIA. NVIDIA Partners with Industry Leaders to Advance Genomics, Drug Discovery, and Healthcare. Press Release, Jan. 13, 2024.

Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

Mike Hennessy Jr is President and CEO of MJH Life Sciences®

When referring to this article, please cite it as Hennessy, M. Pushing Tech Boundaries. 

From the CEO

Artificial intelligence, among other technological advances, is pushing innovation boundaries.

Pharmaceutical Technology, March 2025

Adopting Flexible Strategies to Combat Capacity Shortages

Developments in Aseptic Processing

Pushing Tech Boundaries