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A Risk-Based Approach to Analytical and Formulation Development of Biopharmaceuticals: Optimizing your Strategy will Reduce Cost and Development Time

April 18, 2017  •  Webinar  •  Christina Vessely, PhD
Posted In Other News & Insights


The risk-based approach to analytical and formulation development fundamentally shifts the way many sponsors and manufacturers think about the product development process for biopharmaceutical products, moving away from a minimalistic approach and toward a strategic, forward-looking methodology. This shift prioritizes an understanding of product quality attributes up-front, allowing those insights to inform future processes and decisions, resulting in an efficient, effective and expedited development program.

The advantages of a risk-based approach to analytical and formulation development of biopharmaceuticals have been espoused by both the FDA and EMA. Among the benefits to companies are a reduction in overall development costs and time to market, more favorable FDA reviews, more effective prioritization of resources to address critical issues, and streamlined Agency interactions. Despite the development approach, companies may find their progress impeded by several common pitfalls.

The CMC Specialty Group at Biologics Consulting has helped dozens of companies of all sizes to implement risk-based analytical and formulation strategies successfully, and overcome the obstacles inherent in any biopharmaceutical product development program.

This webinar will provide participants with an in-depth discussion of the benefits of a risk-based approach to analytical and formulation development, a review of common challenges encountered during the development process, and actionable recommendations on how to approach and optimize strategy to reduce cost and overall development time of biopharmaceutical products. The webinar will cover:

  • Top recommendations for Formulation Development of biopharmaceutical products, focusing on:
    • The pros and cons of optimizing formulation at early stage versus later in development
    • Tips for minimizing the need for formulation changes and minimizing overall program risk across the product development lifecycle
    • How to avoid or recover from worst case scenarios
  • Key recommendations for Analytical Development of biopharmaceutical products, covering:
    • Minimum agency expectations at early stage
    • Optimal timing for fit for purpose/qualification/validation studies
    • Opportunities to minimize overall program risk
    • How to avoid or recover from worst case scenarios
  • Overview on common development traps that span both the analytical and formulation realm, tips for how to avoid and suggestions for how to quickly recover from these situations if encountered during the development of biopharmaceutical products.

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About the Host

Christina Vessely, Ph.D. is a Senior Consultant at Biologics Consulting with over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and fast track programs and has participated in pre-approval inspections (PAI) and PAI-enabling activities, including the design and execution of validation studies and evaluation of GMP systems as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).

About The Biologics Consulting Expert Edge Webinar Series

The Expert Edge Webinar Series was created by Biologics Consulting in an effort to share the latest Agency guidance and best practices with leaders throughout the biopharmaceutical and medical device industries. Each interactive, web-based workshop in the series is hosted by an accomplished subject-matter expert and is designed to provide participants with a pathway to success through some of the most complex regulatory and product development challenges in the Industry today.