OCT 13, 2020 9:00 AM PDT

Early Tips 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 enable new therapeutics and advance personalized medicine. 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 experts from Thermo Fisher Scientific: Kasey Kime, Senior Manag¬er of Regulatory Affairs, Clinical and Compliance and Michael Brewer, Director and Global Principal Consultant, Regulatory. As industry veterans, both Kasey and Michael share insights to enabling cell and gene therapy raw materials standardization and regulatory compliance. 

For early stage R&D, there are key elements to consider when selecting reagents and media for cell and gene therapy. Kime emphasizes that performance, quality, and safety be considered from the beginning, while “acknowledging the quality profile does evolve during clinical development.”

Brewer adds that it’s important to choose reagents, process components, media that will meet the most rigorous regulatory expectations because it “avoids the need to make changes, justify those changes and go through the change con¬trol process as you get closer to the clinical and commercial stages.”

On standardization of raw material quality testing, it is important to consider a partner that actively helps drive this.

“One of the things we do at Thermo Fisher Scientific is to ensure we factor in global regulatory requirements for raw and ancillary materials into our product design process,” says Kasey Kime. She shares that not only do regulatory teams contribute to standards development and regulatory initiatives for raw/ancillary materials, but that R&D and product management teams also contribute to industry working groups addressing the importance of standardization of raw materials.

From a comprehensive standpoint, Brewer offers, “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.”

Interested in learning more? 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 > 

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