Payoffs of Advanced Design and Early Implementation
Key to the successful and efficient development of any biologic is the design, implementation and continual refinement of an effective Analytical Control Strategy and Development Plan. The Analytical Control Strategy, part of the Chemistry, Manufacturing and Control (CMC) package, defines those Critical Quality Attributes (CQAs) that impact the safety, identity, strength, purity and quality of the drug candidate.
With the evolution in our understanding of antibody drug development, it is now generally possible to identify and account for potential CQAs arising from structure-function relationships that can adversely impact toxicology and clinical outcomes. The value of sufficiently understanding these and other critical attributes earlier in the drug development cycle becomes abundantly clear when one can apply this knowledge to minimize subsequent study delays, forego repeated studies or avoid unnecessary termination of a development program.
In this webinar, we will present antibody development examples in which unanticipated CQAs and insufficient analytical control strategies adversely impacted the progress or outcomes of IND and BLA submissions, as well as of release of marketed product. We will discuss the importance of defining a better CMC analytical control strategy earlier in preclinical development that will allow one to better anticipate and thus mitigate or avoid altogether these and other development issues.
Presented by
Sian Estdale, PhD,
Principal Scientist, BioPharm CMC, Large Molecule
Dr. Estdale has spent the last 12 years as part of the Covance Biopharm CMC Solutions Team based in Harrogate, UK. Her area of expertise is in protein chemistry supporting the development and QA/QC of biologic and vaccine products. She received her PhD from the University of Sheffield and is a current member of the Scientific Advisory Board for the Biopharmaceutical Emerging Best Practices Association (BEPBA).
Andre Johnson,
Associate Director of Laboratory Operations, BioPharm CMC Solutions, Greenfield, Indiana
Mr. Johnson has spent the last 4 years as part of the Covance BioPharm CMC Solutions Team based in Greenfield, Indiana. His area of expertise is in analytical methodologies for solid/oral dose, topicals and biologics. He was a prior Manager of GMP Operations for Vaccine Analytical Development at Pfizer, and also has previous experience as a QC chemist at GSK, Merck and Bayer.
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Key Learning Objectives
- Application of structure-function relationships to define an effective analytical control strategy
- Understanding CQAs early to reduce adverse outcomes and delays in toxicology and clinical studies
- Other CMC analytical strategies to reveal and mitigate risks to safety and efficacy
- Avoiding pitfalls of generic analytical methods by using a GMP-amenable, molecule tailored approach
Audience
- R&D
- Sourcing
- Quality/QC
- Analytical Development
- Contract Manufacturing Operations
- Bioanalysis
- CMC
- Bioassays
- Immunology
- Protein Scientist
- Assay Dev; Project Mgr & Alliance Mgr