This is an introduction and best practices approach on how to prepare, cryopreserve, and recover cells, cell lines, and tissue for use in cell therapies and regenerative medicine manufacturing.
This proposed American National Standard (ANS) was presented by Dr. Brian Hawkins, Scientific Applications Director at BioLife Solutions, Inc.
The proposed standard is intended to: address the challenges associated with maintaining viable recovery and functionality of cellular therapies and tissue products; discuss the benefits and considerations of low-temperature biopreservation; outline Biopreservation Best Practices for users; and propose considerations for incorporating Biopreservation Best Practices into a GMP cell therapy product.
Producer Interest stakeholders (ex- manufacturers, supply chains, employees of test labs or commercial labs, etc.), those involved in cellular therapies and tissue products, cryopreservation of cells are being sought
Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard.
The deadline to submit notification of interest in serving on the consensus body is September 28, 2018. Applicants should apply by contacting the PDA Standards Manager at firstname.lastname@example.org.