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

Thursday, 07 September 2017  11:30 AM PDT, 02:30 PM EDT

Training Duration = 90 Min                    Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

This training is intended to assist attendees in planning and optimizing their product development programs, especially as they relate to analytical and formulation development.

Learning Objectives:

  • To provide advice on:
  • How to set up efficient formulation development studies
  • Strategies for streamlining analytical development efforts
  • Risks and consequences of delaying certain analytical and formulation development activities to a later developmental stage
  • Basic principles of Quality by Design (QBD) as it relates to analytical and formulation development
  • How to distinguish the "nice to haves" from the critical path items

Why Should You Attend:

This presentation discusses the importance of analytical and formulation development, while taking a critical look at optimal timing and approaches to these activities. Resource constraints, company culture, and financially driven milestones can all impact the decision of when certain activities should be performed, and to what extent.

 By taking a risk based approach to program development, companies can work within their constraints by placing the immediate efforts on the most critical and time sensitive items, allowing for a more streamlined development pathway and higher probability of regulatory success.

Topics

  • Critical activities that must be performed at each stage of development
  • The determination of which activities may be tabled until a later date, and the consequences of those decisions
  • Key strategies for optimizing formulation development
  • Efficient design for analytical development studies
  • How does QBD release to timing decisions?

Instructor

Christina Vessely, Ph.D. has over 17 years of experience in the areas of analytical and formulation development within the biotechnology industry. Her work 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.

Her product experience includes insulin analogs, cytokines, monoclonal antibodies, and other therapeutic proteins, as well as virus-like particles and vaccines. She has been involved in the development and execution of CMC/Regulatory strategy for both biosimilar and novel products, including fast track programs.

Her industrial experience includes the development of both liquid and lyophilized formulations for therapeutic proteins and vaccines, for both traditional and non-traditional delivery systems. In the analytical arena, Christina's areas of expertise have included method development, qualification and validation, the development of reference standards and other critical reagents, stability strategy and evaluation, and establishment of comparability and/or similarity.

She is experienced with various biophysical and biochemical techniques for both the routine release and extended characterization of therapeutic proteins and biotechnology products.