Innovative Approaches to CMC Testing Challenges

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***Live: Wednesday, November 18, 2020 at 10am EST | 9am CST | 3pm GMT | 4pm CET *** Scientific leaders from the United States Pharmacopoeia (USP) and Biogen share perspectives on addressing challenges in chemistry, manufacturing, and controls testing, and provide insights and strategies for a successful path from drug development to commercial manufacturing.***On demand available after airing until Nov. 18, 2021

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Event Overview: Regulators assess the chemistry, manufacturing, and control (CMC) section of a submission to determine if the drug product shows the acceptable limits and analytical methods used to assure the identity, strength, quality, and purity of the finished dosage form.

This webcast will explore how impurities are addressed in investigational new drug (IND) applications, new drug applications (NDAs), and abbreviated new drug applications (ANDAs) in context to small-molecule manufacturing and quality controls and will also include United States Pharmacopeia’s (USP’s) guidance with biologicals.

With increasing trends to investigate clinical targets with multiple modalities, it is challenging to maintain access to analytical capabilities and capacity. This webcast will also explore a published four-quadrant work model and how the approach has evolved, resulting in a dramatic increase in both capability and capacity at reduced cost.

Key Learning Objectives:

  • Review USP approaches to monitoring impurities, including a discussion on existing USP standards and standards under development
  • Gain an overview of how impurities are addressed in INDs, NDAs, and ANDAs, in context of small-molecule manufacturing, including corresponding ICH and FDA guidelines
  • Enable operation of an efficient and sustainable product development organization
  • Learn how smart automation protocols, coupled with targeted project management tools and a strategic approach to insourcing, can vastly improve compliance, robustness, and turnaround times at a significantly lower cost compared to traditional work models.

Speakers: Dr. Annu Uppal, Senior Manager, Scientific Affairs, South Asia, USP

Dr. Christian Zeine, Senior Manager, Scientific Affairs EMEA, USP

Brian Fahie, PhD, Senior Director, Product Technical Development, Biogen

Time and date: Wednesday, November 18, 2020 at 10am EST | 9am CST | 3pm GMT | 4pm CET

On demand available after airing until Nov. 18, 2021

Sponsor: PerkinElmer

Register free: