Susan Haigney

Ask the Expert: Product Inspection, Part Two

In this episode of Ask the Expert, Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, addresses the benefits of automating visual inspection, which include increased efficiency and accuracy, and what goes into the cost versus benefit of automating inspection of small batches.

“[T] he decision to continue manual inspection for small batch sizes involves several considerations,” says Margosch. “So, costs versus benefit, automated inspection systems can still have high upfront costs for small batch sizes. The return on investment maps may still not justify the expenses if the volume does not vary in automation. [One should] evaluate the cost effectiveness of automating small batches versus manual inspection, [and] if possible, conduct a pilot test for automated inspection on the product to evaluate its principal effectiveness and efficiency before fully committing to automation.”

In this episode, Margosch also discusses how cold chain requirements can be maintained during visual inspection. “Maintaining the cold chain for parameters is critical to ensure product stability, especially when visual inspections [that are] typically performed at room temperature,” says Margosch. “Several strategies are available to assure that the cold chain is maintained during inspection, so [one should] develop comprehensive standard operation procedures that outline the processes for handling, storing, transport, and visual inspection that all require cold chain management, include specific protocols for the transfer of products from cold storage to room temperature. [One should] ensure that these procedures are followed and documented. [One should] consistently implement a robust temperature monitoring and alert system for the entire cold chain, that means for both refrigerated transport and cold storage itself, but ensure also a temperature-controlled and monitored transport from cold storage to room temperature all the way … inside the inspection rooms and back, and very important, limit the duration that products are exposed to room temperature during the inspection processes.”

Click the video above to watch Dr. Margosch answer the following questions:

“My company is looking to move from a manual to a fully automated final product inspection method. However, although we manufacture mostly large batch sizes of product, some of our clients require small batch size production for some of their products. Should we continue to inspect those products manually?”

“My company is looking to develop a product that needs to be stored at a cool temperature. How can we assure the regulators that the cold chain is maintained during visual inspection?”

Dirk Margosch is Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG. Since joining Vetter in 2008 as head of automated visual inspection, Margosch has promoted to managing the visual inspection department and, from 2021, overseeing all non-aseptic production, including assembly and secondary packaging.

Margosch joined Vetter in 2008 as head of production overseeing process implementation, product-specific qualification and operation of automated visual inspection systems, until he was given the opportunity to manage the entire visual inspection department including both, manual and automated visual inspection. Since 2021, he has been responsible for non-aseptic production, which encompasses automated and manual visual inspection, assembly, and secondary packaging.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Videos

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection. 

Ask the Expert: Product Inspection, Part Two; Automated Product Inspection and Cold Chain Considerations

DCAT Week 2025: Enzymatic RNA Synthesis

Understanding the critical quality attributes of a whole cell is challenging, remarks Alison Moore, chief technical officer, Codexis, and companies are working on manipulating transcription or translation more directly. 

 spoke with Moore ahead of Drug, Chemical & Associated Technologies Association Week (DCAT Week) 2025 to find out the latest about the RNA therapy market and to get perspective on how enzymatic RNA synthesis is used to synthesize RNA molecules.

“What we've seen is amazing strides by amazing companies in gene therapy,” says Moore. “For example, I think manipulations directly of DNA, where necessary, you know, can create curative outcomes, whether those will be really large, ever really large population size medicines, perhaps not. And that brings me to the RNA space, where manipulating RNA and just the beauty of having very specific transcriptional or translational control is really a lovely concept that is being worked on so actively across many companies, then double clicking a little more into RNA in general. So obviously, the public has seen the utility of mRNA in vaccine development, which remains revolutionary, and we'll see where that goes in the future.”

DCAT Week is happening March 17–20, 2025 in New York City.

Click the video above to watch the full interview.

PharmTech Group spoke with Alison Moore, chief technical officer, Codexis to find out the latest about the RNA therapy market and to get perspective on how enzymatic RNA synthesis is used to synthesize RNA molecules.


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.

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.

Articles

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