Innovative Aseptic Processing of Antibody-drug Conjugates

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.

MabPlex
 

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