Development and Scalability of ADCs and CGTs

Register Free: https://www.pharmtech.com/pt_w/adc_cgt

Event Overview:

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:

• Jasna Curak, Global Quality and External Collaboration Manager, Hoffmann-La Roche Ltd
• 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

This episode of Drug Digest is sponsored by:

• Adare Pharma Solutions
• Catalent
• Dyhydromatics
• ILC Dover
• Ligand
• Veltek Associates

Key Learning Objectives:

• Contributing factors that lead an organization to develop specific biomolecules
• Pros and cons of developing cell and gene therapy (CGT) and antibody-drug conjugate (ADC) candidates
• What makes a robust development process for CGTs and ADCs
• Key considerations for scalability in the development phase
• Targeted therapeutic areas for CGTs and ADCs
• The best approach for consistency and reproducibility

Who Should Attend:

• Developers and manufacturers of cell and gene therapies
• Developers and manufacturers of antibody-drug conjugates
• Biotech firms
• Raw material sourcing companies

For any questions please contact Jorge de la Bandera: Jdelabandera@mjhlifesciences.com

Speakers

Jasna Curak
Global Quality & Compliance
Roche

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. Prior to this, 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.

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 good manufacturing practice (GMP) manufacturing and testing. Her previous background includes seventeen 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.

Register Free: https://www.pharmtech.com/pt_w/adc_cgt