Drug Digest: Development and Scalability of ADCs and CGTs

In this exclusive Drug Digest video, Meg Rivers and Feliza Mirasol interview experts in cell and gene therapies and antibody-drug conjugates. Specifically, they discuss the factors that could influence an organization to pursue specific biomolecules for development; key considerations for scalability; capacity issues; trends; chemistry manufacturing and controls; and how to ensure consistency and reproducibility.

Interviews featuring:

Lisa McDermott, Director of Process and Analytical Development Global Contract Manufacturing Services, MilliporeSigma, the US and Canadian Life Science business of Merck KGaA Darmstadt, Germany: Lisa McDermott is the director of the process and analytical development department at MilliporeSigma in St. Louis, Mo., which is responsible for the development and transfer of custom projects into GMP manufacturing and testing. Her previous background includes 17 years with Monsanto as a synthetic organic chemist working on both agricultural and pharmaceutical projects, followed by seven years at Pfizer with a focus on determining analytical control strategies for GMP success. Over McDermott’s 30 years of experience in synthetic and analytical sciences, she has had the opportunity to contribute to many projects, ranging from discovery to full commercial.

Jasna Curak, Global Quality and External Collaboration Manager, Hoffmann-La Roche Ltd: Jasna Curak is part of Roche Global Compliance and External Collaboration; regulatory intelligence for ATMPs; GMP considerations; currently working with ISPE ATMP community of practice; active in drafting position papers; and is a commenting lead for the global regulatory landscape. Previously, she was in production management in large-scale manufacturing facilities for vaccine manufacturing and a GMP maintenance lead, supporting a reliable and robust process integrated with strong quality infrastructure. She holds a master’s degree in molecular genetics from the University of Toronto, and a bachelor’s degree in biochemistry, molecular biology from McMaster University, Canada.

Sponsors

This episode of Drug Digest is sponsored by:

• Adare Pharma Solutions
• Catalent Biologics
• Dyhydromatics
• ILC Dover
• Ligand/Captisol
• Veltek Associates

About Drug Digest

Welcome to this episode of Drug Digest, a tech talk with the Pharmaceutical Technology editors, who discuss with experts the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Upcoming episodes

• August 2022: Aseptic processing and manufacturing
• September 2022: Solid dosage drug development
• November 2022: Automating pharma and biopharma processes