BSR/PDA Standard 02-201x Cryopreservation Standard Available for Public Comment 23 July, 2020

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of BSR/PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing for public comment. To receive a copy of this draft standard, email PDA at [email protected]. The public comments period concludes September 7, 2020 EDT. There is no charge for the draft standard.

To better harmonize cryopreservation of advanced therapies, including cell and gene therapies, PDA convened a working group comprising experts from academia, industry, and governmental regulatory bodies to compile and draft current best practices into a single reference document. This standard will assist both commercial and clinical groups with their cryopreservation efforts.

On August 7, 2020 BSR/PDA Standard 04-201x, Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters will also be released for public comment.

For more information about PDA’s role in standards development, visit: https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi.

Find answers to standard development questions: https://www.pda.org/scientific-and-regulatory-affairs/pda-standards-frequently-asked-questions or reach out to [email protected].