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ASTM International and BioPhorum Sign Memorandum of Understanding

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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,” notes 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.”

“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,” says Darren Whitman, director and one of the founders of BioPhorum. “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.” 

ASTM International’s E55 committee was formed in 2003 to address issues related to process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. To learn more about the work of the committee, visit www.astm.org/committee-e55. 

Growing from an end-user group in 2008, BioPhorum currently comprises more than 130 bioindustry manufacturers, suppliers, innovators, and service providers across the globe. Members deploy more than 5000 senior leaders and subject matter experts to work across nine phorums, articulating the industry’s technology roadmap, defining the supply partner practices of the future, and developing and adopting best practices in drug substance, fill finish, process development, manufacturing IT, cell & gene therapy, MedTech, and sustainability. Visit www.biophorum.com to learn more. 

 

About ASTM International

Committed to serving global societal needs, ASTM International positively impacts public health and safety, consumer confidence, and overall quality of life. We integrate consensus standards – developed with our international membership of volunteer technical experts – and innovative services to improve lives… Helping our world work better.

About BioPhorum

BioPhorum is a coordinated program of industry change, with a reputation for creating an environment where the global biopharmaceutical industry can collaborate and accelerate their rate of progress, for the benefit of all.


ASTM Media Inquiries:
Dan Bergels, tel +1.610.832.9602; dbergels@astm.org  

BioPhorum Media Inquiries: Claire Astle, Claire.astle@biophorum.com 

Release #11361

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Committee: 
E55
Category: