Webinar | August 24, 2018

Next Generation mAb Processing: Technical And Regulatory Considerations

Source: MilliporeSigma

Next Generation Processing may include linked operations, new processing steps, process pauses, and operation at high concentrations for lengthy periods at different residence times from batch processing. Continuous operation requires a different approach to manufacturing planning while staying in compliance with lot requirements. A risk management framework is suggested as a useful tool to assess and prioritize operation. While next generation processing may be perceived as having higher risks, experience demonstrates that it may be easier and safer than conventional batch operation. Virus clearance data is provided for several processing steps to demonstrate compliance with viral safety objectives.

In this webinar, you will learn:
•    Risks of implementing Next Generation Processing
•    Manufacturing planning with regulatory lot definition
•    Viral safety with new adsorption, filtration, and inactivation steps