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Jun 11, 2024

Mastering the Journey from Initial Method Transfer to Successful Lot Release for Cell & Gene Therapies

Analytical Methods

Contract Testing

Lot Release




Method transfer, common in translational science and cell and gene therapy, involves moving analytical methods between labs as the therapeutic moves through the development pathway. It is crucial to maintain performance consistency, tackle challenges like instrument variation, and ensure thorough stakeholder communication for success.

Once a method is successfully transferred, it must also be qualified and potentially validated, depending on the clinical phase and intended use of the data and product. It is crucial to understand the perspective of the regulators, as well as to understand industry standards and best practices in order to ensure your data and methods will gain approval. This will also support your Investigational New drug Application, expansion, and ultimately Biologic License Application.

This journey is complex with many stakeholders and parties involved, from analytical method development to QC analysts, regulatory experts, and supply chain personnel. Streamlined project management and effective communication are key to success.

Watch this video recording of our Cell & Gene Therapy Insights Live 30 webinar and panel discussion held on June 6, 2024 to hear from a panel of experts who will share potential pitfalls and lessons learned from their many years of experience across a wide array of projects in the cell and gene therapy space.

  • How to avoid common challenges in method transfer
  • Approaches to ensure performance consistency and ensure assay qualification
  • Standard questions and issues identified by regulators during submission review, and how to answer or avoid them
  • Key success factors for effective planning and communication during assay transfer

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