Mastering The Journey From Initial Method Transfer To Successful Lot Release For Cell & Gene Therapies

Successful tech transfer is a critical step in cell and gene therapy development and manufacturing, ensuring that your therapeutic maintains safety and efficacy. This process entails the meticulous transfer of analytical methods between laboratories as the therapeutic progresses through various stages of development. Maintaining consistent method performance across different settings is crucial. Challenges such as instrument variability necessitate careful mitigation strategies. Additionally, fostering thorough communication among all stakeholders is essential for a successful transfer.

Regulatory considerations are of utmost importance. Finding a partner with experience in navigating the regulatory landscape of cell and gene therapies can help support the Investigational New Drug Application (IND), its potential expansion, and ultimately, the Biologic License Application (BLA) process.

Method transfer in cell and gene therapy development is a complex undertaking involving numerous stakeholders, ranging from analytical method developers and quality control analysts to regulatory specialists and supply chain personnel. View the webinar and learn how efficient project management and optimized communication are cornerstones of a successful transfer process.