How the BioLife Solutions Master File Letter Request Process Works for CryoStor® and HypoThermosol® FRS

Cross-Referencing BioLife Master Files

CryoStor and HypoThermosol FRS (HTS-FRS) are critical components in many customer cell and gene therapy (CGT) and regenerative medicine processes. Although they are not regulated medical products-meaning they are not classified as drugs, medical devices, or marketed/registered as excipients-they serve a critical role as ancillary/raw materials in cell-based manufacturing processes.

BioLife Solutions has Master Files registered with the United States Food and Drug Administration (US FDA) for CryoStor and HTS-FRS (as well as other BioLife Solutions Biopreservation Media). These Master Files are relevant only to customer applications submitted to the US FDA. To learn more about US FDA Master Files specifically, refer to their informational page on Master Files for CBER-Regulated Products.

For US FDA submissions, customers may request to cross-reference the applicable Master File. Although this process is not applicable to other regulatory agencies, nonetheless, BioLife Solutions Executive Vice President & Chief Scientific Officer, Aby J. Mathew, PhD, has extensive experience with all major international regulatory bodies and can assist customers through the appropriate communication channels.

How to Submit a Master File Letter Request

Submit your request via our Ask the Scientists form. Include necessary details about your organization and your Master File Letter request. Ensure the details included in the comments field are exactly as they appear in your submission to the US FDA. If a file number has not been assigned, simply specify that instead of using your pre-IND number. Provide contact details (name, email) of the regulatory contact responsible for the FDA submission.

BioLife Solutions can facilitate an efficient and effective process for cross-referencing our US FDA Master Files with customer regulatory submissions. Whether dealing with the US FDA or other international agencies, BioLife Solutions will provide comprehensive support to facilitate your application process.

Again, for further assistance with appropriate support for Customer Regulatory submissions, you may reach out to Dr. Mathew directly via the Ask the Scientists form.