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Challenges in Bio Process Validation: Current and Next Generation

The lifecycle approach to process validation has been an expectation since 2011 but the emergence of new types of bioproducts (including cell and gene therapies), accelerated development and new manufacturing approaches have raised new challenges in meeting process validation expectations. The 2019 ISPE Process Validation Workshop will focus contemporary and novel approaches to meeting or modifying PV expectations and will shape future work to be undertaken by the ISPE Process Validation Team, already authors multiple papers on the practical implementation of the lifecycle approach to process validation. Numerous successful case studies will be included in the presentations. Panel discussion (including regulators), audience polling, and an interactive workshop will facilitate benchmarking and appreciation of the most current issues and potential solutions.

Topics for the 2019 ISPE Process Validation Workshop include:

  • Regulator perspectives on process validation challenges, opportunities for improvement and submission flexibility
  • Process control strategy development and leveraging clinical data for process validation
  • Process validation implications of accelerated development for breakthrough therapies
  • Continuous manufacturing
  • Process validation challenges for gene therapy
  • Validation of CAR-T therapies
  • Regulator perspective on biosimilar submissions
  • Bio drug substance validation process case studies
  • Process validation challenges for biosimilars
  • Statistics for bioprocess validation throughout the product lifecycle
  • Drug product validation for bio products
  • Continuous process verification (CPV) and its impact on process validation
  • Ongoing process verification (OPV)
  • Benchmarking and panel discussion sessions

Learning Objectives

  • Explore challenges and emerging solutions in process validation for current and next generation bioproducts
  • Understand regulator perspectives on challenges and concerns in bioproduct validation
  • Gain insight into regulatory, scientific, and engineering aspects key to successful bioproduct validation
  • Understand challenges in process validation for continuous manufacturing for biologics
  • Learn about leveraging continuous process verification (CPV) data for more efficient validation
  • Discuss process validation regulatory implications for accelerated development
  • Participate in demonstrated application through review of multiple case studies

Who Should Attend?

Professionals at all levels of the industry from young professionals to the most senior executives, Communities of Practice, special interest groups, pharmaceutical industry equipment and services suppliers, and regulatory professionals.

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