Part 1: Thursday, January 28, 2021 | 1:00 PM 4:00 PM (US ET)

Part 2: Thursday, February 4, 2021 | 1:00 PM 4:00 PM (US ET)

Part 3: Thursday, February 11, 2021 | 1:00 PM 4:00 PM (US ET)

Instructors:

Sheila Magil, PhD, Vice President, CMC and Quality, Elevation Oncology, Inc.

Frank Riske, Ph.D., Managing Director at BPTG, BDO

Series Description:
These three sessions should provide a firm grounding in all the CMC tasks for developing and getting to the clinic with a biotherapeutic. Starting from development of a cell line through the requirements for upstream and downstream process developments, analytical methods and formulation. Development of viral products will also be covered. The regulatory expectations and the quality aspects will be covered as well. We will discuss gene and cell therapy as well as recombinant proteins.

Part 1: The Beginning; How to Come up with a Process and Prove it Works

This session describes the fundamentals of biotherapeutic production processes and the application of Quality by Design tools. It is intended to provide the participant with the tools to converse on development and apply its tools for future projects.

Topics to be Covered:

• Cell line development
• Upstream processes
• Downstream processes
• Quality by design

Part 2: Analytics, Formulation and Drug Product

This module will lead the participant through the multiple types and applications of analytical methodologies. Attention will be placed on phase appropriate methods and method qualification. How to develop a formulation and the supporting data needed will be discussed. Production of a biopharmaceutical drug product will be presented.

Topics to be Covered:

• Application of analytical methods during development
• Release, stability and characterization of biopharmaceuticals
• Developing a suitable formulation
• Manufacture of a drug product including some new formats

Part 3: Development of Viral Gene Therapy Products; Regulatory and Quality for Biologics

This module will provide an introduction to the development of viral gene products and discuss some differences from the development approach used for recombinant proteins. The second portion of this module will expand on the quality and regulatory expectations throughout biotherapeutic development.

Topics to be Covered:

• Development and production of viral gene therapy products
• Quality and regulatory aspects of biopharmaceutical production

Who Should Attend:

Any individuals wishing to understand the entire range of activities needed to bring a biopharmaceutical to the clinic and beyond.

Speaker Biographies:

Sheila Magil, PhD, Vice President, CMC and Quality, Elevation Oncology, Inc.

Sheila Magil, PhD is a CMC and quality expert with more than 30 years of experience working closely with both large and small biopharmaceutical companies to bring novel drugs to patients. As a Principal Consultant with BioProcess Technology Consultants, Sheila has helped many companies implement upstream and downstream manufacturing processes, quality control testing and characterization, cGMP compliance, and validation of manufacturing processes and facilities. Sheila was most recently the Managing Director for BDO USA. Sheila has a proven track record of overseeing successful internal and external development activities and preparing a wide range of regulatory filings to the FDA and EMA including 510Ks, INDs, BLAs for biologics and cell and gene therapy related materials. Sheila received her BA in Chemistry from Carnegie Mellon University and a PhD in Biochemistry from the University of Minnesota.

Frank Riske, Ph.D., Managing Director at BPTG, BDO

Frank J. Riske, Ph.D., has over 30 years of experience in the biopharmaceutical industry and has been involved in the development, or improvement, of eight commercial protein products. Prior to joining the BioProcess Technology Group, at BDO, Dr. Riske was a Senior Director in the Late Phase Process Development Group at Genzyme, a Sanofi company. At Genzyme, Dr. Riske was responsible for the development of late stage downstream processes for recombinant enzymes, monoclonal antibodies, viral gene therapies and the identification and exploration of new technologies, including continuous downstream processing. Prior to joining Genzyme, Dr. Riske worked in the field of sustained drug release and IVIG purification at Epic Therapeutics, and has held positions at Repligen and Hoffmann-LaRoche where he developed and improved, downstream processes for proteins produced in mammalian cell culture, E coli, and Pichia systems.