Susan Haigney

DCAT Week 2025: Impact of Geopolitical Climate on Biopharma

® spoke with Joseph Principe, chief commercial officer at Abzena about how current events around the world are impacting the bio/pharmaceutical industry, especially the supply chain and drug shortages.

According to Principe, the current geopolitical climate is creating uncertainty in the bio/pharmaceutical industry. “The industry doesn't really like uncertainty. I think the circumstances around [the] BIOSECURE [Act] or potential tariffs, all sort of create this uncertainty,” he says. “I think that is creating some tailwinds for Western suppliers, particularly those in the [United States]. But again, lots of uncertainty. I think we see that depending on the type of customer that we're talking to, some of the early developers have a little bit less concern about the geopolitical situation, and people who have supply chains embedded in the regions and in many cases, they're looking for alternatives to avoid some of the uncertainty.”

Abzena will be attending DCAT Week 2025, which is happening in New York City from March 17–20, 2025.

Click on the video above to watch the full interview.

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PharmTech sat down with Joseph Principe, chief commercial officer at Abzena ahead of DCAT Week 2025 to get his perspective on how the geopolitical climate is impacting the industry.

DCAT Week 2025: Packaging Innovations

The evolution of personalized medicine and their complexity, such as temperature-sensitive therapies and customized packaging configurations, is impacting the biopharmaceutical packaging market, according to Peter Belden, president of Tjoapack US. 

 spoke to Belden ahead of DCAT Week 2025, which is being held March 17–20 in New York City, to get perspective on how recent innovations in biopharmaceutical manufacturing are impacting the pharma packaging market.

“We've been investing heavily in expanding our cold chain capabilities, in expanding our capability and capacity to package unique configuration for injectable products, whether that is a product that comes to us in a syringe format, a vial format, or an auto injector format,” Belden says. “[We have] the ability to either automate or semi-automate, label, and then finish [to] pack those products while maintaining tight control of time [and] temperature to allow for packaging, and then getting those materials and finished goods back into cold storage. [We also serve] as a potential logistics hub for several of our clients to manage the supply complexity, then shipping those time- and temperature-sensitive medicines to the many markets around the world that our client base is serving.”

Click the video above to watch the interview.

Peter Belden is president of Tjoapack US.

Pharmaceutical Technology® spoke with Peter Belden, president of Tjoapack US, ahead of DCAT Week 2025 to discuss recent innovations in bio/pharmaceutical packaging.

DCAT Week 2025: Challenges of Expanding Market Demand

The pharmaceutical industry is expanding in a variety of areas, with an increased interest in domestic manufacturing in the United States, according to Hamilton Lenox, chief commercial officer at LGM Pharma. 

® spoke with Lenox ahead of DCAT Week 2025, which is being held from March 17–20 in New York City, to discuss how market demand is impacting the industry and creating challenges for the supply chain.

“[One area] where we have continued to see focus and increased demand is more complex formulations in general … we're seeing increased needs in more niche service offerings," Lenox says. “Particularly, where we've seen a lot of growth recently [is] in our suppository demand, which is not traditionally the dosage form for North America for a lot of products. But in the past three years, we have seen increasing demand in the suppository space, some of that has been driven by women's health products, particularly post-COVID.”

Lenox points specifically to the challenge of drug shortages, which he says are increasing in length and add to market demand. “Historically, drug shortages, if you look at FDA data, have lasted anywhere from three to six months,” Lenox says. “In the COVID and post-COVID world, we're not only seeing an increasing amount of drug shortages, but those drug shortages are lasting longer, anywhere from six to 18 months, based on current FDA data as well. So, meeting that demand and ensuring reliable supply to avoid drug shortages [is a challenge].”

Click the above video to watch the interview.

As part of our coverage of this year’s DCAT Week, Pharmaceutical Technology® spoke with Hamilton Lenox, chief commercial officer at LGM Pharma about the expanding pharma market and the challenges such demand creates.

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The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization approval for four medicines in February 2025. The recommended drugs treat a number of types of cancer, immunodeficiencies, and a rare genetic skin blistering disease.

Conditional marketing authorization was given to Lynozyfic (linvoseltamab) for the treatment of the bone marrow cancer, relapsed and refractory multiple myeloma. The generic drug, Trabectedin Accord (trabectedin), was granted approval to treat advanced soft tissue sarcoma and relapsed platinum-sensitive ovarian cancer.

Deqsiga (human normal immunoglobulin) was granted approval as areplacement therapy for primary or secondary immunodeficiencies and immunomodulation in patients with certain autoimmune diseases.

A treatment for the ultra-rare genetic skin blistering condition, dystrophic epidermolysis bullosa, was given a positive opinion. The orphan drug, Vyjuvek (beremagene geperpavec), went through the agency’s PRIority MEdicines scheme, which offers early and enhanced regulatory support. Dystrophic epidermolysis bullosa is caused by mutations in the collagen type VII alpha 1 chain (COL7A1) gene.

In addition to the new drug approval recommendations, CHMP extended therapeutic indications for 16 drugs, including Abrysvo, Calquence, Columvi (an orphan drug), Darzalex (an orphan drug), Enhertu, Imfinizi, Jaypirca, Prevymis (an orphan drug), Rinvoq, Stelara, Supemtek Tetra, and Tremfya.

The indications for Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor) were extended to include patients aged two years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. “This positive opinion brings disease-modifying treatment to all cystic fibrosis patients with modulator responsive mutations,” the agency said in a press release (1).

Ixchiq’s (chikungunya vaccine (live)) indication was extended to include immunization for adolescents 12 years and older to protect against the Chikungunya virus, a viral disease transmitted to humans by infected mosquitoes. 

The orphan drug, Fabhalta (iptacopan), had its indication extended to include treatment of adult patients with the ultra-rare kidney disease, complement 3 glomerulopathy.

At the meeting, CHMP also provided the results from its re-examination of the initial opinion for the indication extension for Keytruda (pembrolizumab) to treat unresectable non-epithelioid malignant pleural mesothelioma. The committee’s original decision was upheld. CHMP also held up its rejection of marketing authorization for Kizfizo (temozolomide) to treat neuroblastoma.

EMA also noted that the application for Pelgraz Paediatric (pegfilgrastim), for the treatment of neutropenia and prevention of febrile in children with cancer was withdrawn. The application of Rilonacept FGK Representative Service GmbH (rilonacept) to treat idiopathic pericarditis was also withdrawn.

The application to extend the indication of Dupixent to treat moderate-to-severe chronic spontaneous urticaria in adults and adolescents was withdrawn as well. In addition, the authorization holder for the COVID-19 vaccine, Bimervax, withdrew the application to include an adapted version to target the JN.1 strain of SARS CoV-2.

At the February meeting, CHMP also stated that the marketing authorization for Leqembi (lecanemab), which received a positive opinion in November 2024 for the treatment of mild cognitive impairment or dementia due to Alzheimer’s disease, does not need to be updated. “In January 2025, the European Commission (EC) asked the committee to consider information on the safety of Leqembi that became available after the adoption of the positive opinion and whether this would require an update of their recommendation. The CHMP has now concluded that its opinion recommending the marketing authorization does not need to be updated and has provided a response to the EC, which will now resume the decision-making process for this medicine,” EMA stated in the press release.

EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025. Press Release. Feb. 28, 2025.

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Treatments for autoimmune diseases, multiple cancers, and skin blistering have been recommended for marketing approval.

EMA Recommends Four Medicines for Approval in February

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Process development is a key factor in the development and manufacture of biologics. Processes must be developed and validated so that product specifications can be met to create a safe and effective biologic drug. Contract development and manufacturing organizations (CDMOs) offer sponsor companies the expertise to develop these processes, which then must be validated. Process validation is a necessity to be sure the manufacturing process produces the desired, safe product.

For cell culture processes, process validation must be performed before good manufacturing practice (GMP) batches can be produced for commercial production, according to Daniel Giroux, vice-president of Biologics Development at Abzena. Formal process characterization studies must then be performed before the process validation so that one can understand the impact of variations of product parameters from their targets. Small-scale studies are performed on a validated scale-down model, and the information obtained is then applied to large-scale production.

Characterization and Qualification of Processes

Bio/Pharma Outsourcing Innovation eBook 2025

“You need to understand what are allowable ranges of process parameters and what will have an impact on your process or on the product quality, and those [parameters] that won’t [have an impact]. Then you define your process envelope …the combination of all these parameters, such as agitation, temperature, feed timing, feed amounts, and so on. [These are determined with] design-of-experiment approaches, because you have to measure [the variations’] impacts, both individually, as they change, but also when they change in combination,” says Giroux.

After process characterization and studies are performed and acceptable ranges established, batch records can be drafted, and validation protocols can be created, says Giroux. “And then you have to run multiple at-scale batches, so you know if your commercial process is going to be at the 2000-L scale, then your validation protocol will dictate how many batches you want to run. A typical number is three. It doesn’t have to be three. It could be more. Possibly could be less, rarely,” Giroux explains. “And then you execute your production batches, and you analyze heavily the impact on the product that’s coming out. You do more analysis than you normally would, something like this, and then you basically show that you met the acceptance criteria that you set up in your validation protocol.”

An essential part of process characterization is the establishment of critical process parameters (CPPs), according to Bob Schrock, PhD, senior director, Global Head of Process Development, at Lonza. Proposed critical process parameters (PCPPs) are obtained after process characterization studies are carried out.

“Once we do all the process characterization studies—and there can be literally thousands and thousands of samples, and [you have] done 12 or 15 different process characterization studies—the results are discussed with PD (process development) and MSAT (manufacturing, science, and technology) and from these, the actual CPPs can be determined,” says Schrock. “These CPPs are integrated into the process, and the validation of the process is then basically what we call the PPQ [process performance qualification] runs, the PPQ runs that are done just prior to commercialization. For [much of the] processes, the cell culture portion is only part of the process, for example, [with] viral vector manufacturing. There’s, of course, purification steps downstream from the [cell] culture portion.”

According to Schrock, PPQ runs show that a process is validated and robust and the number of runs needed depends on the variability of the process. “For a viral vector program that uses a large and well-characterized cell bank, you can do the minimum of three runs if they run perfectly. But for something [such as] autologous cell therapy, where you are starting with different cells from patients or healthy donors, you may need to do more,” says Schrock. “And then, of course, the question of using healthy donors to validate a process that is intended to start with patient samples and patient leukopaks packs, that’s always a deep and spirited discussion where you need to get creative on how you justify that. But at the end of your PPQ runs, you write a huge report that’s part of your BLA [biologics license application] submission, and it’s a cornerstone of your BLA. [It] proves that your process is validated.”

Pharmaceutical Technology®/Pharmaceutical Technology® Europe/BioPharm International

®
eBook: Bio/Pharma Outsourcing Innovation 2025
February 2025
Pages: 22–24

When referring to this article, please cite it as Haigney, S. Characterization and Qualification of Processes. 

Pharmaceutical Technology Bio/Pharma Outsourcing Innovation

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

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Suppliers of raw materials, lab equipment, manufacturing equipment, and other elements that go into the development and manufacture of bio/pharmaceuticals play an important role in the ecosystem that is sustainable manufacturing. Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Stefan Lutz, PhD, SVP of Research at Codexis, a provider of enzymes and enzyme technology platforms, points to organic solvents from petrochemical sources as a “dominating factor” in global warming potential (GWP). “Therefore, technologies that replace organic solvents with aqueous-based processes or enable the design of routes to have fewer organic solvent-using steps are highly desirable in terms of improving this key GWP sustainability metric,” says Lutz. “As an added benefit, enzymatic processes often enable more selective synthesis of target molecules, potentially improving yields and simplifying downstream processing.” For the manufacture of small-molecule drugs, Lutz also points to the use of biocatalysts instead of stoichiometric reagents and rare or precious metal catalysts as potential solutions to for economic or hazardous waste production issues.For large-molecule drugs, such as therapeutic RNA oligonucleotides, Lutz calls out the use of organic solvents as an environmental factor.

“Approximately 3000 kg of acetonitrile is used per kg of RNA produced giving rise to a very large carbon footprint. Enabling higher coupling efficiencies, or fragment-based syntheses, will give higher purity, full-length products that could require less or even no further purification, which is a significant contributor to overall solvent use.”

Codexis has focused on sustainability since the company was founded in 2002, and its enzymatic solutions for API synthesis, asserts Lutz, create higher yields with reduced energy use and less waste. Oligonucleotide manufacturing, for example, uses traditional chemical processes, according to Lutz, that create hazardous reagents and chemical waste and are energy intensive. “By contrast, biocatalytic processes using enzymes generally require milder conditions, utilize renewable resources, and generate less hazardous waste,” he explains.

“Codexis is currently launching its first-in-class Enzyme Catalyzed Oligonucleotide (ECO) Synthesis manufacturing platform to provide a highly versatile and effective tool box for production of therapeutic RNA oligonucleotides. The ECO Synthesis platform addresses critical sustainability challenges of traditional manufacturing methods by eliminating the reliance on hazardous chemicals and significantly decreasing the use of acetonitrile,” Lutz says.

Ecolab—which provides contamination control strategies and solutions, water management programs, and resins for downstream purification—uses greener chemistry principles, material and energy sourcing, and packaging initiatives, according to Christine Yore, vice president, Enterprise Corporate Accounts, Ecolab Global Life Sciences. The sustainable manufacture of biopharmaceuticals is challenged by high water consumption, refrigeration energy demands, and chemical and plastic waste generation, according to Yore. Closed-loops systems and water recycling are key to combat these challenges. The company’s Water for Climate program offers a way for companies to optimize water use across operations, therefore reducing water consumption and minimizing the impact on the environment. “We are also seeing that Digital technology is also playing a key role in sustainability initiatives,” says Yore. “Our Ecolab 3D technology provides key insights to our customers by tracking and monitoring water quality and water flow.” Yore also points to the company’s ion-exchange resin and jetting technologies and its cleaning, disinfection, and decontamination products that help improve operations while reducing environmental impacts. Ecolab has committed to sourcing enough clean electricity via a wind farm to power all of its European operations by 2030. Additionally, in 2023, responsible packaging practices at its facilities avoided 14.5 million pounds of virgin plastic use.”

Verdot, which supplies purification systems for the manufacture of biopharmaceuticals and gene therapies, has been proactively anticipating the sustainability requirements of the companies that use their systems by embedding sustainability into their operations, according to Charles Ruban, president and CEO, Verdot. As part of its sustainability strategy, the company launched carbon compensation initiatives in 2025.

“We have achieved one of the lowest carbon footprints, averaging 100 tons equivalent carbon of equivalent carbon per billion euro in revenue,” says Ruban. “And we’ve done that through eco design, you know, really optimizing the material usage of our products and really selecting appropriately the sustainable supplier that we wanted to work with. … [we are] designing energy efficient equipment that [optimize] material use, and we’re partnering with suppliers committed to systemic sustainability, so our carbon neutral initiative reflects the commitment of overcoming those models while enabling compliance to globally reduce their environmental footprint.”

®
eBook: Bio/Pharma Outsourcing Innovation 2025
February 2025
Pages: 20

When referring to this article, please cite it as Haigney, S. Supplying Sustainably. 

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.