Your Starting Point For Cell & Gene Therapy Regulatory Compliance

Cell and gene therapies hold great promise for improved health outcomes. Now is the time to advance life-saving research to and through the clinical setting. Critical to this is the aspect of raw materials standardization and regulatory compliance, in which it would serve you well to identify and address key considerations early on. To help get you started, we’ve turned to two of our own experts:

Kasey Kime,
Senior Manager of Regulatory Affairs Clinical and Compliance,
Thermo Fisher Scientific

Michael Brewer,
Director and Global Principal Consultant, Regulatory,
Thermo Fisher Scientific

As industry veterans, both Kasey and Michael share insights invaluable to enabling cell and gene therapy raw materials standardization and regulatory compliance. Read on for a brief Q&A:

Q: While still at an early stage of R&D, what are the key elements to consider when selecting reagents and media for cell and gene therapy?

KK: Performance is always going to be very important in early R&D although quality and safety should also be considered. The quality of raw materials needs to be considered according to the stage of development of the cell or gene therapy, acknowledging the quality profile does evolve during clinical development. However, it is still important to assure patient safety even in early clinical development.

MB: In addition, it’s important to choose reagents, components of your process, media, etc. early on that will meet the most rigorous regulatory expectations that will come later in development. This avoids the need to make changes, justify those changes and go through the change control process as you get closer to the clinical and commercial stages.

“One of the things we do at Thermo Fisher is to ensure we factor in global regulatory requirements for raw and ancillary materials into our product design process.” -Kasey Kimes

Q: Standardization of raw material quality testing is a major priority for the sector – how is Thermo Fisher Scientific helping to drive this?

KK: Our global Regulatory Affairs team help support customer and regulatory inquiries on Thermo Fisher reagents and media in CGT manufacturing and actively contribute to standards development and regulatory initiatives for raw/ancillary materials. Our R&D and Product Management teams also actively contribute to industry working groups addressing topics such as the importance of standardization of raw materials.

One of the things we do at Thermo Fisher is to ensure we factor in global regulatory requirements for raw and ancillary materials into our product design process. New and emerging requirements are also considered in our product design because we know the most suitable raw and ancillary materials are those that are designed for this purpose.

Publication of the new ISO working draft for Ancillary Materials present during the production of cells and cellular therapeutic products is also highly anticipated. Once finalized, this will represent globalized guidance to suppliers and developers on best practices to ensure consistent, high quality and safe raw/ancillary materials.

“Partnering with a vendor that has experience in guiding qualification, validation and regulatory filings that have been accepted can streamline the implementation process and reduce the risk of extended regulatory review.”-Michael Brewer

In short, the Q&A above is just a sample of the full insights waiting to be gleaned as you navigate the cell and gene therapy regulatory space. Benefit from deeper insights by joining Kasey Kime and more experts in an on-demand webinar, “Regulatory FAQs and common concerns for cell and gene therapy raw and starting materials.”

Access here >