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

Felicity Thomas

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

In an interview with Pharmaceutical Technology®, Tore Bergsteiner from MAIN5 details his predictions for how the mega trends will shape the bio/pharma industry in 2025 and beyond.

Industry Outlook 2025: A Busy Time Ahead

According to Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations, the mega trends from 2024, such as the digital transformation, supply chain globalization, and regulatory reforms, will continue to keep the industry busy in 2025. Industry hasn’t quite matured enough yet, he stresses, and is still getting to grips with how each of the mega trends will have an impact in the future.

“Breaking it down into operations, AI [artificial intelligence]-driven drug discovery or development will be tremendously accelerated and [enable the] identification of potential new drug candidates by analyzing vast amount of data sets, predicting drug efficacy, and optimizing clinical trial designs,” Bergsteiner says. “This approach [will] reduce time and costs associated with traditional drug development.”

There have already been successes with AI-approaches seen in the field of personalized drugs, Bergsteiner adds. “The human metabolism is so different between patients,” he explains, “but AI enables us to develop treatments tailored to individual genetic profiles, improving therapeutic efficiency, efficacy, [and] reducing adverse reactions.”

Tore Bergsteiner, Managing Partner at MAIN5

Tore Bergsteiner is Managing Partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. Tore has approximately 30 years of experience in industry and has been a pioneering influence in the field of electronic regulatory submissions and within the management and publishing servicing industry. He previously worked for EXTEDO GmbH, a leading international product vendor of electronic approval systems for publicly owned and private pharmaceutical industry, and IABG GmbH, a major German technology and operating company. Tore graduated in Computer Sciences in 1996 and studied at the University of Bremen, Germany, the University of Texas, Austin, USA, and the Julius Maximilian University of Würzburg, Germany.

Pharmaceutical Technology® discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry with Roger Viney, chief commercial officer of ICE Pharma.

DCAT Week 2025: Quality and Compliance for Animal-derived Products

“There are two main differences in terms of quality and compliance that you have to take into account when you're handling animal-derived products,” explains Roger Viney, chief commercial officer of ICE Pharma. “The first is to have steps in your process that ensure biological inactivation, whether it's of course, removal of bacteria, denaturing of DNA, and particularly viral inactivation.”

Secondly, Viney adds that traceability is important: Knowing the exact origin of the animal-derived material means that should there be any issues in a particular country or with a particular disease, it is easy to identify and segregate the material that will be affected, he remarks.

Looking at regulatory requirements, Viney points out that harmonization is critical and allows for increased security of supply. Furthermore, offering fully integrated services is an added benefit for customers as it provides them with the confidence in traceability of the products, he specifies.

 spoke with Viney about the utility of bile acids as excipients to help improve solubility and bioavailability. The interview can be viewed by following the link below:

https://www.pharmtech.com/view/improving-solubility-and-bioavailability-with-bile-acids

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

Pharmaceutical Technology® sat down with Tore Bergsteiner from MAIN5 to discuss the most pertinent and impactful bio/pharma industry trends from 2024.

Industry Outlook 2025: Looking at the Mega Trends

The past year, 2024, was a very active one, remarks Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. “There have been a lot of changes and trends, especially in the political legislative perspective, but also related to new technical trends, influences which are gaining more momentum and maturity,” he says.

Firstly, a key trend for industry, Bergsteiner points out, is artificial intelligence (AI) and the digital transformation that is being seen. “[AI] will become a more and more relevant technique impacting our daily businesses, our overall competitiveness in the industry,” he notes. “And we have to consider that accelerated adoption and processes driven by AI/machine learning or large language models are already reshaping a variety of key processes in pharma.”

The second trend of note for Bergsteiner is the globalization of the supply chain and the monitoring of critical medicines and relevant shortages. “That means diversifying efforts to continue reducing dependency on single regions such as India or China for API, and manufacturing needs to be decreased,” he says.

Continued regulatory reforms and harmonization make up the third key trend from 2024 for industry, emphasizes Bergsteiner. “There are streamlined pathway in the US [United States] and in the EU [European Union], fostering innovation, especially in the area of rare diseases and oncology,” he remarks. “Those [pathways] are pushing companies more and more to continue digitizing their end-to-end processes to remain competitive and regulatory compliant.”

Pharmaceutical Technology® chats with Simon Wright from Almac Pharma Services about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand. 

DCAT Week 2025: Recognizing the Value of CDMOs

Therapeutic modalities are diversifying across the bio/pharma industry, explains Simon Wright, vice president of Business Development for Almac Pharma Services. “Whilst there remains a strong demand for traditional small molecules, we see a higher percentage growth in areas such as biologics, vaccines, cell and gene therapies, and I guess, most recently, peptides,” he says. “And these drugs are administered through various formats, ranging from oral to injectables, but with an increasing trend towards drug–device combinations.”

In addition, regulatory and financial incentives are giving rise to increased attention on novel drugs that treat rare and difficult-to-treat diseases that have smaller patient populations, Wright adds. With these trends in mind, contract development and manufacturing organizations (CDMOs) need to offer flexibility as a strategic partner to innovators, he specifies.

“We're really seeing a desire for more of a strategic partnership versus maybe more of that traditional transaction relationship [from sponsor companies],” Wright says. “I truly believe that the evolution of sponsor CDMO relationships reflects how pharmaceutical companies recognize the value of CDMOs within their overall network and ecosystem. I think that the most strategic relationships today are characterized by strategic partnership approach where companies leverage specialist expertise and trust the CDMOs to assume greater responsibility and deliver substantial value.”

Simon Wright, vice president of Business Development for Almac Pharma Services

Simon Wright is Vice President of Business Development for Almac Pharma Services, part of Almac Group. In his role, Simon leads the business development team across both Europe and North America, and he supports the company’s marketing efforts for the business unit. Simon has approximately 30 years’ experience in the CDMO space.

In an interview with Pharmaceutical Technology®, Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.

DCAT Week 2025: Helping Innovators Progress

“The sterile manufacturing sector is at a real crossroads at the moment,” asserts Ian Lafferty, chief technical officer of Upperton Pharma Solutions. Driven by factors such as the increasing prevalence of chronic diseases, the requirement from industry for sterile manufacturing has been driven upwards at a significantly rapid pace, he remarks. “But, right now, there’s a real deficit in the [sterile manufacturing] capacity, and it is difficult for people to find the right places to go,” Lafferty says.

Difficulties in finding suitable aseptic/sterile manufacturing capacity is particularly prevalent for smaller innovator companies who are looking to develop just one product, Lafferty explains. “They need the CDMO [contract development and manufacturing organization] world to pick up that banner and build facilities,” he specifies. “And it’s not just the facilities; it’s the infrastructure around the appropriate quality management systems, [and] it’s the expertise to support multiple small biotech companies entering into the market.”

For sterile or non-sterile projects, CDMOs can offer some key advantages for innovator companies and the industry in general, Lafferty continues. First and foremost, he adds, having a wealth of expertise and experience in one place is a great help for small innovator companies. Additionally, CDMOs offer facility space for multiple partners, which reduces the need for smaller companies to invest in facilities of their own and provides greater flexibility as multiple projects can be serviced at the same time, Lafferty states.

“Ultimately, [CDMOs are] going to reduce costs [and] reduce timelines while maintaining quality standards,” Lafferty summarizes. “So, it's servicing and giving a place for those small innovator companies to concentrate their efforts on developing the product and the molecules and all the really difficult things they have to do, and then allowing someone else to concentrate on the manufacturing process and the compliance.”

Ian Lafferty, Chief Technical Officer for Upperton Pharma Solutions

Ian Lafferty is Chief Technical Officer for Upperton Pharma Solutions. He has more than 30 years’ experience within the pharma industry and has previously held senior management and executive roles at emerging and growing CDMOs. Ian is a formulation scientist with a background in oral solid dosage, nasal dosage, and sterile dosage forms.

Felicity Thomas

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