On-demand: Ensuring Regulatory Compliance in Cell Therapies from Lab to Bedside

Duration: 10 minutes

In This Webinar You Will Learn About:
  • Short introduction to 21 CFR Part 11
  • Considerations for regulatory compliance in a cell therapy workflow
  • Benefits of leveraging Sartorius instruments and software for cell therapy workflows from R&D to the clinic

Cell-based therapies provide promising new opportunities to treat disease and offer hope to patients in need. Bringing a new treatment to market requires innovative and compliant solutions that can accelerate progress from the lab, all the way to the patient, safely and cost effectively.

During cell therapy research and manufacturing process development, it is crucial to prove that the science functions robustly and the process can be scaled up to the required production volumes. In the unique lab environment of cell therapy, it is equally important to maintain comprehensive and precise electronic records from the equipment used to produce the data in order to streamline regulatory submission and smooth the transition from R&D toward manufacturing.

This webinar will help you better understand the solutions provided by Sartorius that can be used in a cell therapy workflow, with an emphasis on the 21 CFR Part 11 software modules that can be used to simplify compliance.

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Webinar Speaker

Catriona Thomson, PhD

Head of Applications Development

After completing a PhD at the University of Glasgow, Catriona started work as a lab analyst with BioOutsource, a CRO based in Glasgow, Scotland that was acquired by Sartorius in 2015.  Catriona has since held positions in Operations management, technical sales and product development teams.  Key areas of interest include development, qualification and validation of analytical methods and bioassays in a GXP environment, generation of data to support claims of biosimilarity for submission to regulatory authorities and more recently, development of a suite of assays for characterisation of AAV therapeutics.  In her current role, Catriona looks forward to bringing this client-focused experience to the Applications Development team and contributing to their success in producing engaging content to share with a wide audience in the biopharmaceutical industry.

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