The Value of Analytics for Achieving Successful Manufacturing Process Transfer

Duration: 60 Minutes
Transfer of manufacturing processes from one facility to another may be necessary during the product development lifecycle. However, changes in equipment, reagents, and infrastructure can lead to differences in product purity/impurity profiles or glycosylation. Analytical comparability between products and processes must be established to confirm safety and prevent the need for confirmatory clinical studies. Having an appropriate analytical toolbox allows the opportunity to adjust process parameters to improve the probability of meeting demonstrating comparability of the final product.
Analytical Tools for Process Development
Instructor: Christina Vessely
Product ID: 501639
Objectives of the Presentation
  • What analytical tools are available for process development
  • What techniques should be applied for extended characterization
  • How to mitigate risk through the use of analytics
  • Establishing historical ranges and setting acceptance criteria for comparability studies
  • How to design forced degradation studies for establishing comparability
  • How to assess comparability based on the resulting data package
Why Should you Attend
To better understand tools that are available for the establishment of analytical comparability, and also the best times to apply each based on process development stage and clinical program stage.

Areas Covered
  • The product development lifecycle
  • Risk Assessments
  • Early Establishment of analytical methods
  • Establishing Comparability
  • Common challenges with the transfer process
  • Case Studies
Who will Benefit
  • Director
  • Associate director
  • Scientist
  • Associate in the areas of analytics, stability, and process development
$375
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Instructor Profile:
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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