Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Aimee Penko is an engineering execution manager for Arcadis.

Isometric View of a Pharmaceutical Factory - Industrial Design for Prints, Cards, Posters, and Digital Graphics | Image Credit: © Anna– Stock.Adobe.com

The successful build or retrofit of a pharmaceutical facility or lab area depends on competent design deliverables. The design team is challenged with designing a facility that meets client business and regulatory requirements but also incorporates all applicable codes and standards while understanding and mitigating site constraints. Speed to market for a product is often a critical project charter that emphasizes design schedule compression, adding another challenge for the design team. All of these challenges can lead to poor quality of design deliverables if a robust quality plan is not in place.

As the industry faces increased scrutiny to bring drugs to market quicker, and at the same time reduce costs, understanding the nuances of design quality becomes paramount. This commentary is intended to be a primer for companies that are just setting off down their own design path or working with outside consultants to build or retrofit their pharmaceutical facility.

Regardless of one’s level of expertise, however, it pays to be more fully versed on the ins and outs of design quality, and the implications of paying insufficient attention to this aspect throughout the project design phase life cycle.

It’s important to understand the difference between design quality and manufacturing quality. When people in the industry hear the word “quality,” they typically think of “manufacturing quality”—the process of ensuring the product meets validated quality acceptance criteria and is thus safe to release to the public.

Design quality refers to the process of producing technically correct design deliverables that will be used to build or modify an existing pharmaceutical facility. Technical correctness is more than just individual disciplines working on their scope. Accuracy of deliverables takes into account that all scope is shown correctly, follows appropriate codes and standards, meets client requirements, and is coordinated with other disciplines to provide a design that can be constructed and validated.

Drawings should be coordinated with specifications so there is no conflict or ambiguity. Deliverables between disciplines should look uniform by following well-defined project standards. If an engineering or architectural drawing is 100% technically correct but contains multiple spelling and graphical errors, the customer (owner/client, permitting Authority Having Jurisdiction [AHJ], or constructor) may question the accuracy of the deliverable because spelling, format, title block, and revision information errors reflect poor attention to detail.

The backbone of effective design quality is a robust quality management system (QMS). A QMS provides the framework by establishing standardized processes and procedures that the design team will follow. It encompasses the procedures for the entire firm, covering all aspects of design delivery, down to seemingly mundane elements like how drawings are set up and numbered. Adherence to the QMS aligns the team on policies and procedures to streamline operations, but also enhance traceability and accountability.In addition, the QMS establishes a means for continuous improvement of deliverables and procedures through lessons learned feedback.

The QMS framework should be developed in compliance with ISO 9001, which defines the requirements for a quality management system (1). ISO 9001 is the most recognized QMS standard and the only standard within the ISO 9000 series that organizations can be certified to. The International Council for Harmonisation (ICH) Q9 Quality Risk Management guideline is another valuable reference (2). It provides guidance on managing quality risk by providing tools and principles for controlling and communicating the risk.

It’s crucial to understand that while the QMS provides a strong quality framework and documents the processes required for project review stage gates, it’s not enough. Checking a box on a checklist does not always ensure technical quality is achieved.

Technical quality is achieved by orchestrating many different types of design reviews, facilitated by experienced peers, before deliverables are issued on a project. A second set of qualified eyes helps to identify items that might have been missed by someone who has been looking at the same documents for months. This collaborative effort also fosters accountability for design outcomes, for an overall better result that directly addresses facility requirements.

Sustaining design quality throughout the project with a rigorous design review process is paramount. The reviews should happen at a frequency defined in the project execution plan, and certainly before deliverables are issued to the customer. There are multiple different types of design reviews that can be performed on a project.

 All deliverables should undergo an intra-discipline technical check.This check should be performed by a peer from that discipline that is technically competent to review the deliverables. The discipline check should involve reviewing both drawings and specifications for intra-discipline coordination between documents and technical correctness. The checker should also verify quality attributes like format, spelling, revision information, notes, etc. to ensure they are presentable to the customer.

 The squad check is an inter-disciplinary review by all disciplines on a project. It provides the opportunity to review other discipline’s deliverables to ensure scope is coordinated between the team.

For example, a mechanical engineer should review electrical drawings to ensure all mechanical equipment is powered as-specified and safely. A reflected ceiling plan (RCP) should be checked by multiple disciplines such as electrical, mechanical, fire protection, and architecture to ensure there are no clashes between lights, diffusers, sprinkler heads, and ceiling system. The squad check also provides another opportunity to ensure spelling, format, and revision information is correct on the documents. If desired, the squad check exercise participants may include external team members such as the client, construction manager, and/or sub-contractors

 Clash detection is similar in many ways to a squad check, but it’s conducted in the project three-dimensional (3D) model. Coordination software looks for clashes between (new and existing) design elements such as equipment, piping, duct, lighting, walls, and building columns just to name a few. Clashes are not always evident on two-dimensional (2D) drawings, so using 3D visualization makes them easier to identify. The clashes are published to the design team for resolution.

A Building Information Modeling (BIM) coordinator will facilitate this exercise by running the clash detection software, logging the occurrences, and expediting clash resolution between disciplines. Although no design will ever be 100% clash free, the majority of clashes should be resolved before issue, and those that aren’t reconciled shall be documented for the field team to review and mitigate before constructing in the field.

 It’s important to review and mitigate risk throughout the project. Risk assessments can take on many different forms. Initially, the project should be reviewed by leadership to make sure it’s set up for success. The review should focus on scope, project risk, budget, schedule, and execution strategy.

A risk register is another useful tool to help mitigate risk. The risk register is used to document risks identified by the team along with the resolution after discussion with the client. Late project changes are another source of possible risk and can have a cascading effect on multiple disciplines on a project.

For example, if a process change requires ethanol, the project team needs to reevaluate codes and standards to confirm if design changes are warranted. A room may require fire rated walls and a specialized fire protection system where they may not have been required (or budgeted for) previously. This type of risk could be mitigated by conducting a proper third-party peer review to provide contingency guidance to the design team. It’s vital to evaluate and mitigate risk throughout the design development to set the project up for success.

It practically goes without saying, but neglecting design quality can result in dire consequences. The most alarming outcomes include heightened construction and operational safety risk, or even outright project suspension or cancellation impacting availability of the medicines that patients are depending on.

Beyond human impact, however, the financial repercussions of poor design quality can be severe. For design firms, insufficient attention to design quality upfront may affect the bottom-line profit—or worse yet, no profit at all if substantial corrections or changes need to be made to the design after construction begins.

Poor design quality can even expose companies to regulatory actions and lawsuits. This concern cannot be overstated. If a design leads to some type of catastrophe event such as a fire, loss of life, or product recall, the company could be subject to large fines or even lose their license to practice in a particular state.

In this regard, design quality just makes good business sense for companies providing architectural and engineering services to the pharmaceutical industry. A tarnished business reputation affects client trust and loyalty, which obviously makes it difficult to attract repeat clients. In an industry where a trustworthy and honest reputation is essential, the fallout from poor design quality can be catastrophic.

So, for companies that may be embarking on a design project for the first time, what are some fundamental takeaways?

As said at the outset, design quality is inherently different from manufacturing quality. Design quality focuses on ensuring the design team provides quality deliverables that are technically correct, follow all applicable codes and standards, are well coordinated between disciplines, and can be constructed and validated.

Quality must start at the project kick-off by establishing a well-defined quality plan.The QMS provides the framework that defines the processes and procedures for achieving the design objectives and helping to shape the project quality plan. Relying on procedures and checklists alone will not guarantee quality deliverables. The design reviews must be executed by technically competent peers (or subject matter experts) to ensure the accuracy of the design.

When starting a project, one must fully understand the user (customer) requirements and project design charter. The scope of the project must be articulated to design and construction partners to ensure the project team ultimately delivers an optimal facility.

When retrofitting an operating facility, all existing drawings, current manufacturing conditions, and new facility requirements should be shared with the design team very early in the project to plan for minimal production capacity interruption. An early and comprehensive foundation of scope understanding enables an efficient and meticulously detailed project with an accelerated delivery.

Design quality is not merely a regulatory checkbox; it is a foundational element of successful pharmaceutical manufacturing design. By prioritizing a rigorous approach to design quality, companies can mitigate risks, enhance employee safety, and foster a culture of accountability and excellence.

The stakes are high, and the importance of design quality cannot be overstated. As regulatory frameworks become more stringent and the industry evolves, a commitment to design quality will not only protect lives but also safeguard the future of pharmaceutical companies.

ISO. 9001:2015 - Quality Management Systems (ISO, 2021).

ICH. ICH Q9(R1) Quality Risk Management (ICH, 2023).

®
Vol. 49, No. 2
March 2023
Pages: 28-30

When referring to this article, please cite it as Penko, A. Design Quality in Pharmaceutical Design: A Primer for Facility Executives. 

Articles

Design quality in pharmaceutical facilities is crucial for meeting business, regulatory, and safety requirements. It involves producing technically correct design deliverables that adhere to codes and standards, ensuring coordination across disciplines. A robust Quality Management System (QMS) is essential, providing a framework for standardized processes and continuous improvement. Design reviews, including discipline checks, squad checks, and clash detection, are vital for maintaining quality. Poor design quality can lead to safety risks, financial losses, and reputational damage. Prioritizing design quality mitigates risks and ensures successful project outcomes.

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.  

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

On Feb. 28, 2025, FDA informed testosterone product sponsors of new changes to labeling, after the agency reviewed findings from a clinical trial and results from required postmarket ambulatory blood pressure (ABPM) studies (1).

The results of the clinical trial, Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE), will be added to language on all testosterone products, per FDA’s recommendation (1). “Limitation of Use” language is recommended to be retained with regard to hypogonadism—in other words, when the body’s sex glands produce an insufficient level of hormones—that is age-related, and language from the Boxed Warning pertaining to elevated risk of adverse cardiovascular outcomes is slated to be removed.

Meanwhile, data from the ABPM studies have prompted FDA to require other changes to current labeling, namely, adding product-specific information on increased blood pressure for those products that have had completed ABPM studies and a new warning about increased blood pressure for products on which such a warning does not currently appear (1).

FDA said that these labeling changes have roots as far back as 2014, when a Drug Safety Communication issued in January of that year warned of risks that had been reported of stroke, heart attack, and death, specifically, in men who had taken FDA-approved testosterone products (1). A joint meeting of the Bone, Reproductive and Urologic Drugs and the Drug Safety and Risk Management Advisory Committee later that year resulted in the launch of the TRAVERSE trial, for which results were reported in 2023. FDA further recommended APBM studies in premarket development of subcutaneous injection and oral testosterone products in 2016 and 2017, respectively, following that with the issuing of a postmarket requirement in March 2018 that individual ABPM studies be conducted for all such products.

FDA frequently provides updates on changes to drug labels, or when those labels have been deemed to be misleading. An example of the latter occurrence happened in December 2024, when the agency 

announced Endo USA, Inc.’s voluntary recall

 of all lots of a vasoconstrictor for topical application, Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials (2). In addition to that product never having been approved by FDA, it was found to be misbranded with a misleading label similar to another FDA-approved drug made by the same company, which, in FDA’s estimation made telling the difference between the non-sterile topical product and the approved sterile injectable difficult, leading to potential administration errors.

In February 2025, Astellas Pharma said that FDA 

updated the labeling for its avacincaptad pegol intravitreal solution

 (brand name IZERVAY) by approving the drug to treat geographic atrophy secondary to age-related macular degeneration without a limitation on duration of dosing (3). That approval followed a resubmission in December 2024 of a supplemental new drug application for the solution.

 in December 2024 explaining procedures and criteria for the agency’s accelerated drug approval for serious conditions (4). Contained in that document was a stipulation that one of the conditions or requirements for accelerated approval is that “a succinct description of limitations of usefulness and anticipated benefits must be included in the drug label’s Indications and Usage section with a reference to the Clinical Trials section” (4).

In its release regarding labeling changes based on the TRAVERSE trial, FDA reminded both patients and healthcare professionals to file anyadverse events or quality issues stemming from a medication’s use to its 

MedWatch Adverse Event reporting program,

completing and submitting an online form,

 and faxing it upon completion to 1-800-FDA-0178 (1).

1. FDA. FDA Issues Class-Wide Labeling Changes for Testosterone Products. Press Release. Feb. 28, 2025.
2. FDA. Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors. Press Release. Dec. 20, 2024.
3. Astellas Pharma. US FDA Approves Expanded Label for Astellas’ IZERVAY (avacincaptad pegol intravitreal solution) for Geographic Atrophy. Press Release. Feb. 13, 2025.
4. FDA. 

Expedited Program for Serious Conditions–Accelerated Approval of Drugs and Biologics, Guidance for Industry, Draft Guidance

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

FDA Makes Class-Wide Labeling Changes to Testosterone Products

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

Industry Outlook 2025: Looking at the Investment Environment

When reflecting on trends that shaped the bio/pharma industry in 2024, Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics, explains that the investment environment has been his primary thought. “Investment is the oil that gets everything moving and enables us to do the process development, the work, and the product development in the end,” he says.

While investment has been tough over recent years, Forte asserts that there was a slight pick-up in activity during 2024, albeit at a slow pace. “We also saw people looking into different opportunities,” he continues, “[which] in a way is telling us that companies are finding different ways of funding so that they can continue their activities.”

Moving into 2025, Forte anticipates that industry will witness two kinds of M&A: one being activity between similar-sized companies that will combine for synergistic reasons and to optimize costs, and the other being straight acquisitions that will take a technology into Big Pharma and accelerate the development of a therapy to the patient-level. “We're going to obviously be impacted by these bigger acquisitions, because it's bigger value, and we see the value of Big Pharma really taking these products to patients,” he adds. “But in the background, there's going to be a series of smaller deals that will have that synergizing ability, bringing two companies of similar size together with broader geographic scope, broader equity story proposition, and that's what we're going to see.”

Miguel Forte, president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics

Miguel Forte is president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics—a company developing engineered cell therapies for inflammatory diseases. Miguel holds an MD and a Specialist in Infectious Diseases from the Faculty of Medicine, University of Lisbon, a PhD in Immunology from the University of Birmingham, and a certificate on Health Technology Economics from the Stockholm School of Economics. Additionally, he is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.

Videos

In an interview with Pharmaceutical Technology®, Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the M&A landscape from 2024 and his expectations of what is to come next.

Charles Ross & Son Company (Ross), of Hauppage, NY, announced in a press release on Feb. 28, 2025 a new purpose-built perfluoroalkoxy (PFA)-coated ribbon blender (1). The company said the blender has been designed specifically to meet the needs of “sensitive and challenging” applications—meaning, ones for which a stainless-steel or carbon-steel coating may not be appropriate or compatible.

Ross, founded in 1842, is a producer of industrial mixing, blending, drying, and dispersion equipment, according to the company’s website (2). Its mixers can be found in use in a wide range of industries including, but not limited to, food, cosmetics and personal care products, chemicals and pharmaceuticals, animal health products, and polymers and plastics.

In this design, a durable PFA coating, black in color, covers the interior of the trough, the double ribbon agitator, bolted stub shafts, and the funnel of the valve (1). The blender’s knife gate valve, the company said, is dust-tight, and its ease of operation ensures a smooth discharge process.

According to the press release, the coating is not available only for this model; it will be able to be optionally applied to various sizes of Ross’ ribbon and paddle blenders (1). The working capacity of the specialized PFA-coated ribbon blender is 5 cu. ft. When applied in this context, according to Ross, PFA coatings prevent product contamination and steel corrosion, promote material release, and simplify cleaning (1).

Overall, Ross said the controls of the specialized blender are operator-friendly to the extent that they feature a forward/reverse function (1). The company highlighted the equipment’s ease of use for applications such as powders, pellets, and slurries, among others.

Further information on Ross ribbon blenders can be found in the December 2024 issue of 

 In particular, the company said at that time that its Model 42N-10, among a line customized for heavy-duty and sanitary applications, is designed for free-flowing materials with bulk densities up to 100 lbs. per cu. ft.

 about its V cone blenders, which utilize diffusion as their main mixing mechanism, allowing batch materials to cascade down and distribute particles over a freshly exposed surface.

The announcement of the new blender’s specifications followed Ross’ disclosure of a price reduction (up to 40%) on its Series 100 and Series 500 Production Batch High Shear Mixers, effective in January 2025 (3).

A previous technology report from Ross on design considerations for tumble blenders was published in May 2024 and is available for download 

 Tumble blenders are effective for dry solid blends, low-viscosity slurries, and formulations of trace components that differ in size, shape, and density.

1. Charles Ross & Son Company. ROSS PFA-Coated Ribbon Blender for Sensitive Applications. Press Release. Feb. 28, 2025.
2. Charles Ross & Son Company. About Charles Ross & Son Company–Industrial Mixers Since 1842. 

 (accessed March 5, 2025).
3. Charles Ross & Son Company. Competitive Prices on ROSS Batch High Shear Mixers. Press Release. Jan. 29, 2025.

The company said this blender supports applications for which either stainless steel or carbon steel may not be suitable.

Ross Announces PFA-Coated Ribbon Blender to Be Offered for Sensitive Applications

Business cooperation strategy to create value for customers achieve the goal. | Image Credit: © Thanadon88 - stock.adobe.com

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. 

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

In an interview with Pharmaceutical Technology®, Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.

Industry Outlook 2025: Consolidating Data and Relaxing Regulations on AI

As the technology agenda progresses for industry, Mike Baird, director of product management for Schlafender Hase, a German software company, expects the primary impact of advanced tools to happen in the compliance space. “AI [artificial intelligence] is a very generic term,” he emphasizes. “But machine learning and large language models in particular are going to be at the forefront of this [trend], because that's where all the data can be consolidated.”

However, the transition to automated and digital-led processes will not happen overnight, Baird asserts. “[These tools] are like babies, and we have to teach them how to do things,” he says. “And so, once the teaching is in place, and once we get the models trained, then they can really help in this area of compliance and adhering to regulations.

Looking at the potential M&A activity for industry over the coming 12 months, Baird anticipates that if interest rates continue to go down, then we should be looking at a more favorable landscape in the near future. However, the change in government administration in the United States also leads to a little bit of uncertainty, he adds.

The new administration may lead to some challenges, particularly around drug pricing, Baird speculates. “[But], going back to the technology side of things, one thing that I'm not certain of, but I think might be a good prediction, is that there'll be a relaxation in the regulations surrounding AI,” he notes. “I think this administration is a big supporter of technology, which is great, but also a big supporter of AI, and where that can take us, and what that can do for the for the industry.”

Mike Baird, Director of Product Management for Schlafender Hase

Mike Baird is Director of Product Management for Schlafender Hase—a German software company. Mike’s role is to develop software to meet and exceed the needs of customers. He has more than 25 years of experience working with global packaging, labelling, pre-media, and artwork management leaders in the pharmaceutical and medical device sectors.

CordenPharma announced on March 5, 2025 that pursuant to a previous announcement made in July 2024, it has finalized plans to construct a state-of-the-art peptide manufacturing facility at Getec Park in Muttenz, Switzerland, close to the major European biotech and pharma hub of Basel (1).

The company said the news reflects a desire to expand its peptide platform business to a sales milestone of more than €1 billion by 2028 (1).

 said that CordenPharma was investing approximately €900 million (US$983 million), over a period of three years, to expand its peptide platform at its site in Colorado, in the United States, and at a greenfield site to be constructed in Europe (2).

“We are excited to announce the construction of a state-of-the-art manufacturing plant just outside Basel, Switzerland, within one of the leading pharma and biotech hubs in Europe,” Michael Quirmbach, president and CEO of CordenPharma Group, said in a company press release. “The new facility is designed to deliver flexible and efficient peptide manufacturing to meet the growing demand of innovative peptide medicines for our customers and ultimately, patients.”

Since the spring of 2024, CordenPharma has announced or updated numerous partnerships that collectively aim to ease strains along the drug pipeline. 

 said that a collaboration with the contract research organization, GENEPEP, which designs, synthesizes, and optimizes peptides, peptide libraries, and proteins, was combining CordenPharma’s current good manufacturing practice capacities and regulatory experience with GENEPEP’s expertise in the areas of discovery and drug development (3). In June 2024, CordenPharma 

 for the purpose of developing a portfolio of ionizable lipids for lipid nanoparticle-based drug formulations (4). Also coming that same month was an announcement that a consortium 

between CordenPharma and contract manufacturer WACKER,

 formed by a contract awarded by the German government in 2022, had entered a readiness state in its mission to produce and supply vaccines to prepare for potential future pandemics (5).

An increased focus on the peptide market, specifically glucagon-like peptide-1 (GLP-1) drugs, has driven a flurry of activity in the first quarter of 2025. Demand for GLP-1s, which has the potential to tie up aseptic filling capacity, was 

 to watch for in the year ahead by Pharmapack Europe and CPHI (6). In January 2025, BioDuro opened a fully automated solid-phase 

 in Shanghai, China (7). And in February 2025, 

 it was looking toward the development of next-generation therapeutics such as GLP-1s, in announcing a €50 million (US$52 million) investment in its site in Mourenx, France, making the site a center of excellence within the company’s network for contract manufacturing of APIs and drug substances for biologics that have been FDA approved (8).

1. CordenPharma. CordenPharma Expands Peptide Platform with >€500m Greenfield Facility Construction in the Basel Region of Switzerland. Press Release. March 5, 2025.
2. CordenPharma. CordenPharma Invests €900m in Transformational Peptide Platform Expansion in the USA & Europe. Press Release. July 16, 2024.
3. CordenPharma. CordenPharma & GENEPEP Celebrate Strong Collaboration Leveraging Peptide Drug Substance Discovery & Clinical Development Expertise. Press Release. April 17, 2024.
4. CordenPharma. CordenPharma & Certest: A Powerful Partnership Unleashing the Potential of Patented Ionizable Lipids in LNP Formulation. Press Release. June 6, 2024.
5. WACKER. WACKER & CordenPharma Enter Pandemic Readiness on 1 June 2024 After Successful Expansion & Qualification. Press Release. June 19, 2024.
6. Pharmapack Europe. Pharmapack Predictions 2025: the Good the Bad and…. the Donald 2.0. Press Release. Jan. 13, 2025.
7. BioDuro. BioDuro Opens New Solid-Phase Peptide Synthesis Scale-Up Facility. Press Release. Jan. 9, 2025.
8. Axplora. Axplora Announces €50 Million Investment in GLP-1 Manufacturing at Mourenx (France) Site. Press Release. Feb. 12, 2025.

The company first announced its intention to build the state-of-the-art facility as part of a €900 million investment in July 2024.

CordenPharma Selects Switzerland Site for Peptide Manufacturing Facility

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

Behind the Headlines Episode 12–Cell and Gene Therapies, New Genomics Tools, and Recent Partnerships

 is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In this episode of Behind the Headlines, Brian Feth, CEO and founder of Xcell Biosciences; Thomas Heathman, chief commercial officer of Ori Biotech; and Matthew Lauber, Sr director of BioSeparations, Waters Corporation, discuss commercialization challenges in the cell and gene therapy (CGT) space and advances in new genomics tools from Roche, Illumina, and Eikon. In addition, the panelists review Biogen’s and Stoke Therapeutics’ collaboration for the development and commercialization of zorevunersen, a therapy for Dravet’s syndrome (1); Thermo Fisher Scientific’s purchase of Solventum’s purification and filtration business (2); and Eli Lilly’s $27 Billion plant expansion in the United States due to tax breaks extensions and tariffs threats

Pfizer said the discontinuation of its last remaining cell therapy program was due to several reasons, including “limited interest in gene therapies for the bleeding disorder…However, the company said it will redirect its time and resources towards Hympavzi, an injectable drug approved in October to prevent or reduce bleeding episodes in hemophilia A or B patients aged 12 years and older” (3). Our panel pointed out that a good amount of business process and commercialization rationale went into this decision. This coincides with the Carlysle groups purchase of a CGT Pioneer bluebird bio, for only $30 million (4), and illustrates investor wariness and strong commercial headwinds for the CGT field. 

Recently, new genomics tools have been introduced into the market. Roche has unveiled a new class of next-generation sequencing with its novel sequencing by expansion technology (5), while at the same moment Illumina unveils first-of-its-kind spatial transcriptomics technology (6). In the same moment, Eikon has released novel single-molecule tracking technology, demonstrated through “clinical studies now operating in 28 countries, across five continents, we are accelerating the development of much-needed therapies while continuing to expand our research and development capabilities,” said Roger M. Perlmutter, MD, PhD, CEO and Board Chair of Eikon Therapeutics, in a press release (7).

Biogen. Biogen and Stoke Therapeutics Enter into Collaboration to Develop and Commercialize Zorevunersen for the Treatment of Dravet Syndrome, a Rare Genetic Epilepsy Associated with Refractory Seizures and Neurodevelopmental Impairments. 

Thermo Fisher Strikes Deal for Solventum’s Filtration Unit

Santhosh. C. Pfizer Stops Commercialization of Hemophilia Gene Therapy Beqvez, 

Carlyle. bluebird bio Announces Definitive Agreement to be Acquired by Carlyle and SK Capital. 

Roche. Roche Unveils a New Class of Next-generation Sequencing with its Novel Sequencing by Expansion Technology. 

Illumina. Illumina Unveils First-of-its-kind Spatial Transcriptomics Technology. 

Genetic Engineering News. Eikon Therapeutics Raises $350 Million to Support Clinical Stage Programs, Pipeline Development. 

Brian Feth, Xcell Biosciences; Thomas Heathman, Ori Biotech; and Matthew Lauber, Waters Corporation go behind the headlines and discuss commercialization challenges in the cell and gene therapy space; advances in new genomics tools from Roche, Illumina, and Eikon; and the latest development and manufacturing partnerships. 

Pharmaceutical Technology® discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer with Mike Baird from Schlafender Hase.

Industry Outlook 2025: From the Perspective of a Software Developer

Looking at the various industry trends from the technology side of things, Mike Baird, director of product management for Schlafender Hase, a German software company, specifies that digitization has been hugely interesting. “When I say digitization, I'm not talking about emailing an Excel spreadsheet around to people. I'm talking about dedicated tools and solutions that that link workflows and processes together to try and make them as seamless as possible,” he says. “As as far as I'm concerned, digital maturity is a measurable thing, and we can we use certain tools to help us educate our customers, to help us understand them and their needs.”

Another key trend for industry has been the drive from regulators to move from paper to electronic product information. During 2024, within the European Union, the European Medicines Agency completed its Fast Healthcare Interoperability Resources program— aimed at determining whether a move to more digital based products would work— successfully, Baird specifies.

Additionally, another big trend from 2024, and a few years prior too, was artificial intelligence (AI), which has had its ups and downs in terms of acceptance and denial by industry but is now starting to settle down, Baird adds. “People are getting some level of acceptance in how and where [AI] can be used,” he says.

Cheryl Barton is director of PharmaVision, 

On 30 Jan. 2025, the European Commission (EC) launched a new Biotech and Biomanufacturing Hub to help European Union (EU) businesses, particularly small and medium enterprises (SMEs), to access support, expand, and grow (1).

The Hub offers access to EU funding for research and development (R&D), business development tools to market products on a global scale, regulatory guidance on product approval, and compliance and support for intellectual property rights to protect innovative products (1).

The Hub is accessible on the EC’s Your Europe portal to EU nationals, nationals of European Arenas Association (EAA) countries, family members of EU/EEA nationals, non-EU nationals that enjoy EU rights, and businesses with headquarters in a EU country (2). A task force of advisors will guide the continuous development of the portal (3).

In June 2023, the EC proposed a regulation to establish a new platform for Strategic Technologies for Europe Platform (STEP) (4). STEP aims to support the development and manufacturing of critical technologies and to address any shortage of labour and skills. Several proposals were outlined in STEP to boost biotechnology and biomanufacturing in the EU, these are summarized in 

Figure 1. Proposals outlined in the European Commission’s Strategy to boost biotechnology and biomanufacturing in the EU. Figure courtesy of the author

On 1 March 2024, the STEP Regulation (Regulation (EU) 2024/795) came into force (6). The STEP platform has access to €160 billion in funds to invest in strategic projects that develop or manufacture critical technologies namely:

biotechnologies—molecular biotechnology, pharmaceuticals, crop biotechnology.

clean and resource-efficient technologies—capture and storage technologies, and heat pumps.

digital technologies and deep technology innovation—artificial intelligence (AI), advanced connectivity, and quantum technologies (4).

STEP stakeholders include governments, regulatory bodies, industry leaders, research institutions, and the public. The STEP Task Force coordinates and cooperates with stakeholders to address funding challenges and identify new opportunities.

The EU aims to bolster its industrial competitiveness, enhance its strategic autonomy and resilience, and boost its economic security through investment in biotech and biomanufacturing, and the Hub is a key element of the EC’s strategy (7).

STEP has invested in 11 EU programmes including:

Digital Europe Programme (DEP): Provides funding for projects including advanced digital skills AI, cybersecurity, supercomputing, and ensuring the wide use of digital technologies across the economy and society (8).

European Defence Fund (EDF): This supports collaborative research and development (R&D) of defence capabilities with the EU budget (9).

EU4Health: Established in response to COVID-19’s impact on medical and healthcare staff, patients, and health systems in Europe. It aims to improve and foster health in the EU (10).

Horizon Europe (HE): Aims to tackle climate change and helps to achieve the United Nations’ (UN’s) Sustainable Development Goals and boosts the EU’s competitiveness and growth (11).

Innovative Fund (IF): One of the world’s largest funding programmes for the demonstration of innovative low-carbon technologies (12).

Additional funding has been provided by STEP to the European Regional Development Fund (ERDF), Cohesion Fund, European Social Fund+ (ESF+), InvestEU, Just Transition Fund (JTF), and Recovery and Resilience Facility (13).

The EC continues to strengthen the competitiveness and resilience of the European economy through investment in transformational technologies. The investment in the Biotech and Biomanufacturing Hub will not only support innovative European biotechs but also sends a clear message to the rest of the world that Europe means business (14).

EC. New Biotech Hub to Support Companies. ec.europa.eu. 20 Jan 2025.

Stur, B. New Biotech and Biomanufacturing Hub Will Support Innovative European Companies. European Interest. 2 Feb 2025

EC. Your Europe–Advice. ec.europa.eu (accessed 14 Feb. 2025).

EP. Strategic Technologies for Europe Platform (STEP). Think Tank. 15 Feb 2024.

Eteris, E. Biotechnology and Biomanufacturing in the EU: Perspective Strategy - Analytics, EU Law & Governance. Analytics, EU Law & Governance, Integrin Dk. EG in Europe. 15 May 2024

EC. Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024 Establishing the Strategic Technologies for Europe Platform (STEP) and Amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241. ec.europa.eu. 29 Feb. 2024.

EC. Building the Future with Nature: Boosting Biotechnology and Biomanufacturing in the EU. EC.europa.eu. 20 Mar 2024.

EC. Digital Europe Programme. ec.europa.eu (accessed 14 Feb. 2025).

EC. European Defence Fund. ec.europa.eu (accessed 14 Feb. 2025).

The Biotech and Biomanufacturing Hub will help European companies access funding, navigate regulations, and speed up market access.

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