ASTM International and BioPhorum Sign Memorandum of Understanding

Global standards organization ASTM International and the biopharmaceutical industry collaboration group BioPhorum have signed a memorandum of understanding (MoU) aimed at accelerating standardization within the biopharmaceutical industry.

The MoU is focused on accelerating innovation and advancement in bio and new modality manufacturing to bring solutions to patients faster. By formalizing this relationship, BioPhorum and ASTM aim to ensure that the right priorities are being worked on to advance biopharmaceutical industry standards.

In particular, desired outcomes of the MoU include:

• Alignment of industry, agency, and standards body (industry stakeholder) strategies and priorities;

• Acceleration of guidance and standards development; and

• Technical alignment and accelerated adoption of regulatory guidance and standards, within the biopharmaceutical industry.

“ASTM is excited to collaborate with BioPhorum to promote scientific collaboration in developing and adopting standards and best practices within the biopharmaceutical industry,” said John R. Logar, past chair of the ASTM International board of directors and current chair of ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55). “We believe this partnership has the potential to compress standards development lead times and encourage the broader acceptance and use of standards while delivering mutually beneficial value to the members and companies that support both partners.”

Darren Whitman, director and one of the founders of BioPhorum, said, “We are delighted to have reached this agreement with ASTM and look forward to working together to make a significant impact on the speed with which standards are created and then broadening their adoption. BioPhorum’s members will provide unique insights to the collaboration and the wealth of data and information they have created since 2008 will further support our combined objectives.”