Biolife Solutions is a pioneer in the biopreservation industry, and the key to our success is the relationships we form with our customers to support and help them implement best biopreservation practices.
Use the form to contact our team of Scientists for assistance with your biopreservation questions.
Ask The Scientists, a key customer support initiative of BioLife Solutions, is intended to be a multi-channel resource that links customers directly to our team of on-staff scientists. We welcome questions and feedback from our customers and prospective customers, and value the unparalleled direct communications and relationships that have led to products like HypoThermosol®, CryoStor®, and Stemulate hPL® or any of our mechanical equipment being incorporated into several hundred customer clinical applications, articles/abstracts citations, and poster/data references.
For more information or if you have a question for the BioLife Solutions scientific team, please submit your questions at http://www.biolifesolutions.com/ask-the-scientists.
Here is an example of a representative customer question, and our feedback:
“I need to submit regulatory documentation about HypoThermosol FRS and CryoStor, but your media is proprietary. How can you support our regulatory documentation needs for US FDA and outside the United States?”
HypoThermosol FRS and CryoStor have been qualified into 275+ customer clinical applications as an ancillary material or excipient. Biopreservation media for cell manufacturing are not classified as drugs or devices, and therefore do not carry specific therapeutic regulatory approvals. Within their classification as ancillary materials in a customer’s process (or excipient if utilized in that manner by a customer), they are reviewed within the context of the customer’s process. Each group would qualify the ancillary or excipient usage within their specific cell product application.
To assist customers with clinical applications requiring regulatory submissions, BioLife Solutions has registered Type II Master Files (for a Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product) for HypoThermosol FRS and CryoStor with the United States Food and Drug Administration (US FDA) Center for Biologics Evaluation and Research (CBER).
The Master Files may be cross-referenced during the submission process, allowing the US FDA to review the BioLife Solutions Master Files. The Master Files contain detailed information regarding Good Manufacturing Practices (GMP) compliance in use during the manufacture, testing, storage and distribution, but the contents of the Master Files are confidential, and disclosure is restricted to the US FDA.
We look forward to supporting the increasing number of partner customers through their clinical development, as well as their Biologics License Applications and Marketing Authorization Applications.