Ian Burdick

Oct 10, 2024 | cellandgene.com | Tyler Menichiello |Chris Hofmann |Ian Burdick |Todd Jasinski

Setting the Standard in Cell and Gene Therapy, TogetherSartorius shares your mission to develop life-changing cell and gene therapies. Accelerate commercialization with end-to-end solutions that deliver reproducibility, scalability, and the quality needed to simplify regulatory approvals. From discovery, to process development, to clinical and commercial manufacturing, our portfolio of proven solutions helps you achieve faster time-to-market while saving costs.

Apr 12, 2024 | bioprocessonline.com | Nathan Parker |Claus Exenberger |Jean-Sebastien Steffen |Ian Burdick

The introduction of ICH Q14 to analytical procedure development provides guidance on the recommended approach to assay development and the justifications regulatory bodies require to demonstrate the development of a method. While applying an AQbD approach may require more upfront work, the advantages are a better understood and more robust method, with greater regulatory flexibility.

Dec 12, 2023 | cellandgene.com | Kate Coleman |Kenneth Ndugga-Kabuye |Ian Burdick |Evan Hagen

Webinar: Practical Applications Of ICH E6(R3): What Do We Need To Do? Join industry experts December 14 as they discuss the strategic, conceptual, and operational implications of the shift toward risk-based monitoring in the ICH E6(R3) draft guidelines, and what sponsors and vendor partners should already be doing to thrive in the future of clinical trial management. Click here to learn more.