Podcasts

In the current industry landscape, API quality can make or break a drug product. LGM Pharma stands out by treating supplier relationships as strategic partnerships rather than transactions. In this interview with Pharmaceutical Technology, Shailesh Vengurlekar and Diem Hoang share LGM’s rigorous, multi-step process for evaluating, approving, and continuously monitoring API manufacturers—highlighting the company’s collaborative approach that prioritizes transparency, and patient safety.

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.

There is not a syringe solution that fits all challenges. In this Podcast, Enrico Barichello, Product Manager for Syringe Platform in Stevanato Group, and Alan Xu, Product Manager for Analytical Services in Stevanato Group's Technology Excellence Centers, discuss the best strategies to select the right pre-filled syringe (PFS) based on the key needs of combination products and illustrate how introducing analytical services from an early stage can help customers reach the market faster by avoiding costly product revalidations or reformulations. Don’t miss out on the opportunity to be part of the conversation driving the PFS industry forward.

Join this insightful dialogue where we’ll explore advancements in the evolving world of cell and gene therapy analysis with Daniel Galbraith, Chief Scientific Officer of Solvias. Daniel shares insights from the forefront of drug development, including the complexities of development and commercialization, the financial dynamics of new therapies and changing regulatory landscapes. This podcast provides an enlightening conversation about the dynamic cell and gene therapy analysis space and provides a unique look at the innovations driving the industry forward.

In this podcast, hear from our global experts Martin Gonzalez, PHD and Katharine Sparhawk as they share exclusive details of Pfizer CentreOne’s sterile injectable capabilities from both a technical expertise and business development point of view. Our experts will explore key topics including emerging sterile injectable trends, the company’s approach to flexibility in capacity planning and emerging trends that are shaping the development of complex biologics like ADCs.

Polyimide materials, as Kapton®, are widely used for flexible electronics substrates or as insulators, thanks to their wide range of thermal stability as well as excellent dielectric and mechanical properties. However, there are limitations in their processability and employment in new technologies due to their low solubility and deep amber staining, resulting from charge transfer interactions established between polymer rigid chains. Currently, researchers are focusing on designing resins with excellent thermal and chemical stability, transparent and colorless with a high processability in terms of viscosity and solubility. However, balancing among all those properties for this class of materials remains a big challenge today, as some of these properties seem to exclude others. In this episode, the focus will be on aliphatic anhydrides, which play a key role for the final polyimide’s properties enhancement. This will be explained by B.Sc. Sara Greco, a chemist working on this topic (as part of her master's thesis) in the R&D department of Valsynthese, a Swiss CDMO specialized in hazardous chemistry.

Dr. Luca Mantilli, R&D chemist at Valsynthese, the fine chemical unit of the Société Suisse des Explosifs Group (SSE), will guide you through the journey that Valsynthese as CDMO has done in phosgenation. The advantages and synthetic possibilities of phosgene, an extremely versatile reagent, will be highlighted with respect to other alternatives, same as the safety measures needed when working with such hazardous building blocks.

Tom Fletcher, director of Research and Development at FUJIFILM Irvine Scientific; and Bob Newman, PhD, chief scientific director at FUJIFILM Irvine Scientific, discuss formulation, specifically with how to prepare culture media for use, single use technologies, and automations to create closed systems in cell/gene therapies with former Pharmaceutical Technology editor Jill Murphy.

Jet milling is a well-established particle engineering technique for producing micronized powders with controlled particle size distribution and increased surface area. This makes them suitable for inhalation drug delivery. However, successful implementation of jet milling requires a robust Quality by Design (QbD) approach that ensures the critical quality attributes of the micronized particles are maintained throughout the process development. This episode will cover the principles and intricacies of the jet milling process. It will also highlight some of the challenges when micronizing for inhalation delivery, and give some possible solutions. A case study will demonstrate a reliable process development strategy using a QbD approach for micronizing nilotinib, an API with potential for the treatment of severe chronic asthma. It will highlight the significance of implementing a QbD approach, and its benefits in process development. Overall, this presentation aims to provide valuable insights into the jet milling process and QbD approach for inhalation drug delivery and their potential applications in drug development.