Susan Haigney

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

BASF announced on June 17, 2025 that it has opened a good manufacturing practice (GMP) facility in Wyandotte, Mich. as part of the company’s commitment to providing a reliable supply of bioprocessing ingredients and excipients to the biopharma and pharmaceutical industries. The facility expands on BASF’s existing network of GMP sites. BASF Pharma Solutions is a manufacturer of excipients and APIs.

The new facility will feature state-of-the-art cleanroom packaging and high-sensitivity analytical testing capabilities. These will allow the company to customize chemistries for product development and provide more tightly controlled parameters beyond compendial limits and a validated control system, according to a press release (1).

“Our new GMP Solution Center exemplifies BASF’s dedication to understanding and addressing the evolving needs of our customers in both the biopharma and pharmaceutical industries,” Marion Kuhn, vice president of business management, BASF Pharma Solutions, said in the press release. “This state-of-the-art facility will play a fundamental role in enabling us to collaborate closely with our customers worldwide on product development and GMP manufacturing in ways that are unique to the industry, further strengthening our position as an innovator in the pharmaceutical sector.”

“Wyandotte’s new GMP Solution Center is a key example of BASF’s commitment to innovative excellence,” added Benjamin Knudsen, vice president of research North America at BASF Corporation. “This expansion not only showcases our dedication to developing customized solutions, but it also highlights our ability to adapt and innovate in response to our customer’s needs. Together, we are paving the way for new innovative solutions.”

The quality of pharmaceutical ingredients is imperative for ensuring a robust and safe drug supply chain. Poor-quality APIs that do not meet standards may destabilize drug formulations, creating quality control problems and regulatory actions that result in drug recalls (2).

“From a supply chain perspective, poor-quality APIs increase the likelihood of production interruptions, which disrupt the supply to the market,” Qixuan Lu, vice-president of Process Chemistry at BioDuro, said in an interview about API quality with 

® (2). “Because of the poor-quality API, additional quality control measures become necessary, driving up costs and diminishing profit margins. If such issues arise repeatedly, they can harm a company’s reputation and undermine market confidence in its products. Beyond these commercial setbacks, manufacturers also face considerable legal and regulatory risks if they fail to meet the standards required for pharmaceutical quality and patient safety.”

 video interview, experts discussed key trends impacting small-molecule APIs and excipients, the importance of supply chain resilience, ways in which advanced manufacturing approaches can prove beneficial, and potential hurdles facing companies seeking to secure their small-molecule API and excipient supply chains (3).

BASF. BASF Strengthens Its Commitment to the Biopharma and Pharmaceutical Ingredients Industries through a New Investment in North America. Press Release. June 17, 2025.

Haigney, S. Poor API Quality Threatens a Healthy Supply. 

https://www.pharmtech.com/view/poor-api-quality-threatens-a-healthy-supply

Thomas, F. Drug Digest: Securing the Supply Chain for Small-Molecule APIs and Excipients. 

https://www.pharmtech.com/view/drug-digest-securing-the-supply-chain-for-small-molecule-apis-and-excipients

Articles

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

BASF Opens GMP Manufacturing Facility in Michigan

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

FDA announced on June 17, 2025 that it has created the Commissioner’s National Priority Voucher (CNPV) program to help shorten the review times for drug approvals. The program provides a voucher that drug developers can redeem so they may participate in a novel priority program that will shorten the final drug application submission review time from 10–12 months to one to two months. The program will begin in 2025 with a one-year pilot phase. The number of vouchers will be limited in the first year of the program to “companies aligned with US national priorities” (1,2).

Experts from FDA offices will meet for a “team-based review” as part of the new CNPV process, with a multidisciplinary team of physicians and scientists reviewing clinical information and pre-reviewing submitted information in a one-day “tumor board style” meeting.

Participants in the program may also be granted accelerated approval if applicable legal requirements are met. In addition, the program will offer enhanced communication between the agency and the sponsor.

To qualify for the program, applicants must meet the following criteria:

must address a health crisis in the United States

must deliver more innovative cures for the American people

must increase domestic drug manufacturing as a national security issue.

Applicants must submit the chemistry, manufacturing, and controls part of their application and the draft labeling at least 60 days before submitting their final application. Sponsors are expected to be available for prompt, ongoing communications with the agency during the CNPV review. “FDA reserves the right to extend the review window if the data or application components submitted are insufficient or incomplete, if the results of pivotal trial(s) are ambiguous, or if the review is particularly complex,” the agency stated in the press release.

FDA may direct vouchers to specific investigational new drugs or grant a voucher to a company as an undesignated voucher, which would allow the voucher to be used for a new drug at the sponsor company’s discretion. Vouchers, however, are non-transferrable to other companies but will remain valid through changes in company ownership. Vouchers must be used within two years of receipt (2).

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary in a press release (1). “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a one-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”

“This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time. We are confident this more efficient process can be achieved without cutting any corners on safety or scientific evaluation,” said FDA Principal Deputy Commissioner Sara Brenner.

FDA’s existing Priority Review Voucher (PRV) program will continue as is and is separate from the new CNPV. PRV will have a different timeline for review (2).

FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. Press Release. June 17, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests

FDA. FAQs: Commissioner’s National Priority Voucher Program. 

https://www.fda.gov/news-events/press-announcements/faqs-commissioners-national-priority-voucher-program

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.

FDA Voucher Program Provides Shorter Drug Application Review Time

BIO 2025: Pulmonary Drug Delivery

PharmTech Group spoke with Andy Burns, vice-president of MDI Business Development at Kindeva, about trends he is observing in the pulmonary drug delivery field as part of our preview of the BIO International Convention, which is being held from June 16–19, 2025 in Boston.

According to Burns, sustainability is a focus of a lot of pharmaceutical companies and stakeholders. “A lot of our clients and customers have their own well-developed set of policies and procedures that they wish their partner organizations to subscribe to, and certainly very progressive in Europe and the UK and also in the [United States],” Burns says. “So, sustainability and the impact on supply chains, both within Big Pharma, but also their associated contract manufacturers, is certainly a theme that I've seen developing over the past the past few years.”

Click the video above the watch the interview.

Andy Burns, vice-president of MDI Business Development at Kindeva.

Videos

PharmTech Group spoke with Andy Burns, vice-president of MDI Business Development at Kindeva, ahead of BIO 2025 to find out what’s new in pulmonary drug delivery.

Abstract vertical illustration of targeting cancer cell made of glowing neon particles. Blue geometric background depicting cancer cell screening and disease treatment medical concept. Digital art | Image Credit: © artacet - stock.adobe.com

The biopharmaceutical industry has seen exciting advancements in the past decade, with cell and gene therapies, personalized medicine, messenger RNA (mRNA) vaccines, and new treatments for autoimmune diseases. The global biopharma industry is expected to increase at a compound annual growth rate of 8.97% from 2025 to 2030; this growth is suspected to result from a demand for targeted therapies, new alliances, and increased innovation (1). The oncology field is also making an impact, with immunotherapies, cell therapies, and gene therapies advancing quickly (2).

As more and more new modalities reach regulatory approval and enter the market, David Kuntin, CEO and cofounder of Mesenbio, sees the biopharmaceutical market becoming more diverse with a number of highly targeted treatments, such as antibody–drug conjugates (ADCs) and next-generation antibody therapies (e.g., bispecific antibodies) being developed. “Cell and gene therapies (CGTs) are also advancing, though interest in early-stage assets is waning; we can expect more gene therapies for inherited diseases and CAR [chimeric antigen receptors]-T or other cell-based therapies expanding beyond rare cancers into more common conditions, if pricing is something that can be addressed,” Kuntin says. “Messenger RNA-based products will certainly move beyond traditional vaccines—for instance, there is significant effort in mRNA therapeutics for cancer vaccines and protein replacement therapies. Crucially, these modalities won’t exist in isolation. Many will become established alongside traditional biologics. For example, an autoimmune condition might in the future have treatment options ranging from monoclonal antibodies to an mRNA therapy or even a cell-derived product.”

Other approaches, such as extracellular vesicle (EV) therapeutics, are in development and are a promising new class of regenerative or delivery agents, according to Kuntin. “Overall, the future commercial landscape will not be dominated by one modality but characterized by a wide array of therapeutic approaches, each tailored to different medical needs. This rich diversity is exciting and marks a shift toward more personalized and precise medicine; though, it also means our industry must support a broader range of manufacturing and regulatory strategies to bring these treatments to patients.”

“I’m excited to see multispecific antibody- like biologics synergistically block multiple cancer cell survival pathways or help induce immune responses, such as cell-killing we are currently seeing with cell therapies,” Christian Cobaugh, chief scientific officer and founder, Vernal Biosciences, says. “Multispecifics are also offering more favorable target product profiles and potentially better outcomes in oncology.”

Lipid nanoparticles (LNPs) and mRNA have become “derisked,” according to Cobaugh, and the clinical data from LNP-mRNA for gene editing and oncology are impressive. “Most of the 

 gene-editing programs that we see from companies like Intellia, Beam, and Verve rely on LNP-mRNA (plus guide RNA) and can be dosed to effect,” Cobaugh says. “Further, the therapeutic cancer vaccines are another great way to leverage the speed to clinic that mRNA manufacturing offers.”

While a significant number of illnesses will still be addressed by small-molecule drugs, according to Miguel Forte, president, ISCT, board member, ARM, and CEO Kiji Therapeutics, biologics offer the ability to target certain diseases with specificity and mechanism of action. “If a patient has a genetic disease, it is likely that the best approach would be gene therapy,” Forte says. “I would expect cell, and gene-edited cells to play a major role in oncology—as is already the case—and also in autoimmune diseases, in parallel and possible combination with biologics.”

Diversification in the bio/pharmaceutical industry that provides a mix of traditional small-molecule drugs, biologics, and vaccines may drive more targeted therapies and intensify market competition, according to Max Baumann, cofounder, Treehill Partners.

“As we observed in an industry analysis we performed comprising 1200 clinical programs, only a minority of companies currently optimize their development for commercial success,” Baumann says. “Combined with increased segmentation of clinical end markets, this has a significant impact on the return that potential pharmaceutical drug development offers for investors, and absent a clear investment thesis, not all the products we currently see in development will be successful in securing funding to market entry and break-even.”

Innovation often comes at a cost, however, and this must be balanced. While the industry benefits from the cycle of innovation, formulation, and production, says Oury Chetboun, CEO, Seekyo Therapeutics, new drugs also must be cost effective for patients and to develop and produce. “You may have a fantastic drug in the lab which costs a massive amount to be scaled up, but if you can’t get that into a large-scale production or at a reasonable cost, then you can’t do anything,” Chetboun cautions.

Each patient has different needs, and each disease is different; therefore, a mix of formulation and drug delivery methods is needed for optimal treatment, according to Chetboun. Patient adherence is also important, however. Complying with a treatment plan is easier for patients when fewer doses or administrations are required. Side effects may also impact patient adherence, making multiple delivery route options more attractive, suggests Chetboun.

Creative formulation and drug delivery strategies are necessary for new modalities to reach patients, Kuntin says, and he sees less invasive administration as a major trend. Nasal and inhaled formulations for vaccines and antibody therapies might advance, which could target drugs to mucosal tissues. “There is also significant interest in achieving oral delivery of biologics; traditionally, proteins and nucleic acids get digested in the gut, but new techniques like protective coatings, nanoparticle carriers, or special capsule devices are showing promise in allowing antibodies or peptide therapies to be taken as a pill,” Kuntin explains. “While not every biologic will become a tablet, even a few successes in oral biologic delivery would be paradigm-changing for chronic treatments.”

 cell therapies, mostly CAR-Ts and HSCs [host cell proteins], have validated some key mechanisms of action including gene editing. But those therapies are more akin to procedures, and highly invasive and risky ones at that, than they are products. I’m looking forward to advancements in non-viral genetic delivery technologies, such as LNPs and PNPs that can de-target the liver and retarget blood and immune cells to transform these procedures into products that can be dosed to effect.”

Stability and distribution of new modalities is also critical, says Kuntin, with development ongoing to formulate drugs that remain stable at refrigerator temperature or room temperature, therefore removing the need for ultra-cold storage.

“We’re likely to see more use of advanced carriers like lipid nanoparticles, which have already proven their worth in delivering mRNA vaccines and could be refined for other drugs,” Kuntin says. “Looking further ahead, there is exploration of novel delivery vehicles—for example, utilizing extracellular vesicles as a natural means to carry therapeutic molecules to target tissues. EVs in particular could signal a new paradigm in biologic delivery, with production approaches able to be intrinsically integrated into the EV production process.”

Advancements in technology, such as artificial intelligence (AI), machine learning (ML), and digitization, have played a part in the development of new and innovative modalities. The ability to work with large amounts of data and manage processes digitally may accelerate processes and reduce cost, according to Forte. “Importantly though are the opportunities to accelerate development by providing faster data analysis, scenario elaboration, and digital comparison approaches (digital twins) that will overall improve the process and speed of development,” he stresses. AI can also facilitate the exploration of different models and conditions by using digital twins, adds Forte. “In this context, the conditions and requirements for scaling up can be modeled and analyzed, accelerating the process overall,” he notes. 

“In biologics design, for example, machine learning algorithms can suggest modifications to an antibody or protein to improve its efficacy and stability, or even help design novel therapeutic proteins from scratch,” Kuntin says. “This means we can generate and evaluate a wider range of therapeutic options 

 before moving to lab experiments, saving time and resources. I’ve seen cases where an AI model predicts how a change in a molecule’s structure might affect its function or how a particular patient subgroup might respond to a therapy—insights that would have taken much longer to glean through trial and error in the lab.”

According to Cobaugh, AI is also helping design antisense oligonucleotide therapies and locating gene-editing sites. He also sees AI playing a role in predicting and designing antigens for personalized disease treatments.

“We’ve also seen how tools like Alpha-Fold3 are using machine learning to accurately predict the structures of most biomolecules, including proteins and nucleic acids, reducing what used to be a dissertation’s amount of work to a day or two of computing time. Labs, such as the David Baker lab, are now able to take a de novo approach to design completely synthetic proteins with specific functions in mind,” Cobaugh says.

The development pathway can be streamlined by digitization, using advanced data analytics and automation in preclinical research, says Kuntin. “AI-driven analysis helps interpret complex datasets, such as finding patterns in thousands of data points from early safety studies or optimizing formulation conditions for a new modality. In clinical development, digital tools assist in trial design and patient selection—for instance, algorithms can match eligible patients to clinical trial protocols more effectively or predict outcomes using real-world data, which helps in designing smarter trials. Overall, these technologies are accelerating development timelines and helping us make more informed decisions at each step. The end result is a higher probability that truly effective therapies make it through to approval by focusing our efforts on the most promising candidates and approaches.”

Digital technologies can “create a smoother bridge” across discovery and manufacturing, according to Kuntin, with critical factors and ideal settings for production identified faster with fewer errors. AI/ML can then play a bigger role in commercial manufacturing by monitoring production in real time.

Baumann adds that AI/ML can bridge the gap by facilitating tech transfer through digitally capturing and standardizing process knowledge. “This integrated approach supports faster, more reliable scale-up and reduces the risk of costly manufacturing setbacks,” he says. 

“Modern biologics facilities often use advanced sensors and control software that adjust process conditions on the fly, guided by AI models that have ‘learned’ from the development data,” Kuntin says. “This means we maintain consistency between a small lab batch and a large manufacturing batch. I’ve found that even for complex new modalities—like extracellular vesicles—having a strong digital data backbone from R&D through to production makes tech transfer much more seamless. It reduces the risk for surprises during scale-up and helps get therapies from the bench to the patient more reliably and efficiently. I would say, however, that caution must be exercised whenever these tools are used, and to avoid over-reliance on these, as there is a tendency to treat AI solutions as ‘black boxes’—a totally obscured machine with the ability to pump out data—without truly critically evaluating the outputs. There are clear and important distinctions between generative AI approaches and those that use existing data and draw connections and contextualize these into meaningful outputs, and that is a crucial thing to bear in mind when using AI in drug development, especially when interrogating large data sets.”

“There is significant value to be generated in two main areas,” says Bauman, “namely, ‘doing the right thing/development strategy—where AI/ML can be instrumental in identifying and supporting the best strategic direction and avoid mis-steps that may put an entire company on an inferior path—and ‘doing things the right way’/execution of key tasks along the development journey, where error rates can be reduced, equations be better solved, and ultimately better development outcomes be created through aggregating thousands of slightly improved puzzle pieces,” says Baumann.

New biopharma modalities, along with new technology, have given patients new opportunities and provide value to society, according to Forte, and they could lead to advancements in other areas and product types.

Kuntin sees some new modalities becoming established treatment options in the next decade. “Not every new modality will succeed commercially—each must prove not only clinical benefit but also that it can be delivered to patients reliably—but I am optimistic that a good number of them will become staples in the medical toolkit,” says Kuntin. “In my view, we’re seeing a co-evolution: as therapeutic modalities mature, they push the industry to develop new production capabilities, and as manufacturing technology leaps forward, it expands the realm of what therapies can successfully reach patients. The end result is that patients should benefit from a broader range of treatment options, and these will hopefully become more affordable and accessible as manufacturing efficiencies improve. The future biopharma landscape will be defined by this synergy between groundbreaking science and equally innovative manufacturing.”

“The interplay between modality innovation and manufacturing evolution will define the next decade of biopharma, driving both operational excellence and improved patient outcomes. We remain cautious about the current geopolitical environment inflicting fundamental changes to our industry, which range from choice of production location to pricing of the end product and with that affect the commercial attractiveness/viability of geographical markets across the globe,” Baumann says.

1. Grand View Research. Biopharmaceutical Market Size and Trends. 

2. Haigney, S. Emerging Treatments for Cancer. 

BioPharm International. Next-Generation Biotherapeutics

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

Advancements in Biopharma Spur Innovation

 on June 4, 2025 that it has opened its Advanced Technologies Laboratory in Rockville, Md. The lab and related expertise will be utilized to develop and scale innovations to create efficient and expanded drug production that the organization believes will help secure supply chains. The lab builds onto USP’s 70,000 square feet of laboratory space located across the United States and India. The organization plans an additional 8000 square feet of lab space in 2026.

The new lab will be used to expand drug production and secure supply chains

The lab builds onto USP's 70,000 square feet of laboratory space located across the United States and India.

The lab will allow USP to assist manufacturers in the adoption of advanced manufacturing technologies by developing approaches and processes for flow chemistry as well as the use of advanced analytical techniques.

The lab will allow USP to assist manufacturers in the adoption of advanced manufacturing technologies by developing approaches and processes for flow chemistry as well as the use of advanced analytical techniques (e.g., process analytical technology) to enable real-time quality monitoring. The development of alternative and novel synthetic routes for API production will also be supported with key starting materials. “Taken together, these capabilities are essential in efforts to create stronger supply chains through strategic onshoring, distributed manufacturing, and personalized medicine,” USP stated in a press release (1).

“Advanced manufacturing technologies make possible the responsive, distributed manufacturing and onshoring strategies that make our medicine supply chains more secure and reliable. But adoption at commercial scale can be challenging, especially for generic manufacturers,” said Ronald T. Piervincenzi, PhD, chief executive officer of USP, in the release. “The Advanced Technologies Lab will help launch and scale innovations that get products to patients more efficiently, while strengthening our medicine supply chains.”

USP’s end-to-end supply chain analytics and solutions include chemical precursors for finished drug products and comprehensive mapping of the supply chain to identify safety risks. The new lab will assist in the adoption of new technologies to mitigate these supply chain risks and establish guidance to support regulatory actions and create efficiencies to strengthen domestic drug manufacturing.

The supply chain of APIs, other materials, and finished drug products is an ongoing concern for both manufacturers and regulators. Risks to the supply chain include poor API quality, which can result in interruptions in production (2). “Because of the poor-quality API, additional quality control measures become necessary, driving up costs and diminishing profit margins. If such issues arise repeatedly, they can harm a company’s reputation and undermine market confidence in its products. Beyond these commercial setbacks, manufacturers also face considerable legal and regulatory risks if they fail to meet the standards required for pharmaceutical quality and patient safety,” Qixuan Lu, vice-president of Process Chemistry at BioDuro, 

European Commission has proposed the Critical Medicines Act

 to improve drug production and secure the drug supply chain in Europe. The Act addresses problems associated with manufacturing capacity, diversification, dependencies on foreign materials, and market demand (3).

“The Advanced Technologies Lab exemplifies USP’s commitment to advancing efficient, quality, and sustainable pharmaceutical manufacturing through the application of cutting-edge technologies,” said Emily Kaine, SVP of Global Health and Manufacturing Services, in the USP press release (1). “USP’s unique capabilities and decades of expertise can help overcome the barriers that have limited the adoption of advanced manufacturing technologies. Doing so will help ensure that the medicines people rely on for health are available when and where they’re needed.”

USP. USP Announces New Advanced Technologies Laboratory to Accelerate and Scale Pharmaceutical Manufacturing Innovations. Press Release. June 4, 2025. 

https://www.usp.org/news/usp-announces-new-advanced-technologies-laboratory-to-accelerate-and-scale-pharmaceutical-manufacturing-innovations

Barton, C. Critical Medicines Act Plans to Improve Supply Chain. 

https://www.pharmtech.com/view/critical-medicines-act-plans-to-improve-supply-chain

The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.

USP Opens Advanced Technology Lab in Maryland

A CDMO’s Role in API Quality

Contract development and manufacturing organizations (CDMOs) can offer services across different modalities and, often, across different regions, according to Martin Meeson, CEO of Axplora. CDMOs also audit their ingredient suppliers to ensure quality. These services can help ensure API quality, thereby helping to secure the supply chain.

“We look to [our suppliers] for the same commitment to quality that we have. In order to apply that across the supply chain, we have to have a structure like this, because you have to be quite agile in the industry that we've got. We're all people [who] want speed, reliability, and quality built in,” Meeson says. “But we have to find a way to have a supply chain that's robust and can operate with a little bit of agility to make sure that we can get the medicines through to the patients that we supply. I think [being science based] is a really important part of underlying quality. It is a very technical piece of operation we do to have that level of science embedded.”

Meeson recommends that pharmaceutical companies partner with companies that have quality embedded into their operations. “It's not something that we turn off; it's absolutely embedded in everything that we do, in every piece of day-to-day operation. It's absolutely the heart of what we do every day,” Meeson says. “This is exactly what [pharma companies] should be looking for, because that ensures the robustness of the supply of the medicines that we are making for the patients that are out there.”

Click the video above to watch the interview.

Pharmaceutical Technology® spoke with Martin Meeson, CEO of Axplora, about the role contract development and manufacturing organizations have in ensuring the quality of APIs and the security of the supply chain.