Axplora

Watch SKAN AG’s Richard Denk and Bausch+Ströbel‘s Thomas Buehler as they dive into the latest developments in Innovative Aseptic Processing of Antibody-drug Conjugates.

With four antibody-drug conjugates (ADC) approved by the U.S. Food and Drug Administration (FDA), the development and manufacturing of targeted ADC therapies has become a booming field. Due to the intrinsic complexity of these drug entities, development and manufacturing of antibody-drug conjugates remains very challenging. Strict containment is required to guarantee the protection and safety of both operators and products.

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KEY LEARNING OBJECTIVES

In this webinar learn how to unlock, understand and leverage key information, including:

  • Understanding the complexities of the production and manufacturing of antibody-drug conjugates (ADCs)
  • Identifying key industry trends related to ADC containment requirements and why this is important
  • The laws related to occupational hygienic validation and cleaning validation with a brief overview of primary regulatory requirements and industry standards (FDA, EMA, ISO,ICH, USP, PDA, USP)
  • Gaining insight into Technical solutions for operator and product protection and safety, including approaches for contamination control, as derived from FDA, ISO, and USP
  • An introduction to VarioSys – a Flexible Procession Line based on the ‘Lock-and-Key’ principle

WHO SHOULD ATTEND

  • Managers and scientists at biopharmaceutical companies and contract research labs
  • Operating, maintenance, calibration, qualification managers and staff
  • QA members

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