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Development of Analytical Methods and Characterization: Considerations for GLP/GMP Stability Studies - Webinar

  • ID: 4210019
  • Webinar
  • May 2017
  • Region: Global
  • 90 Minutes
  • Online Compliance Panel
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The goal of this presentation is to provide information on what is expected for stability studies at different program stages. This will include discussions of what items are required vs. nice to have at each stage, as well as discussing how best to develop and select methods for use in evaluating product characteristics during real time and accelerated storage.

Objectives of the Presentation:

- Developing phase appropriate methods
- Applying forced degradation to confirm stability indicating nature of methods
- Fit for use and assay qualification studies - when are they necessary and how is the data applied?
- Stability study design and execution
- When/how should extended characterization methods be applied to stability studies?
- Evaluation of stability data

Why Should you Attend?

- To gain a better understanding of assay development practices, especially as they relate to stability studies
- To understand agency expectations for stability programs at different clinical stages

Areas Covered:

- Assay development
- General principles
- Forced degradation studies
- Assay qualification study design and execution
- What is a complete study?
- What are the GMP requirements?
- Stability study design and execution
- What timepoints and which assays at each timepoint
- Implementation of extended characterization methods into stability studies
- Evaluation of stability data
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  • Christina Vessely Christina Vessely,
    Senior Consultant ,
    Biotechnology Industry

    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.

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  • Stability program leads
  • Analytical development scientists
  • Regulatory / CMC leads
  • Quality control managers
  • Stability coordinators
  • Laboratory directors
  • Stability department personnel
  • R&D laboratory personnel
  • R&D laboratory supervisors and management
  • QC laboratory personnel and management
  • Protein formulation group personnel and management
  • Regulatory affairs personnel
  • Regulatory affairs management
Note: Product cover images may vary from those shown