Cell and gene therapies may now be moving faster than the manufacturing networks built to deliver them.
The Alliance of CGT Manufacturing Partners (ACGMP) is launching a global network of independent, specialist contract development and manufacturing organisations (CDMOs) to help close that gap.
The alliance aims to give developers a coordinated, no-cost way to identify partners with the technical capabilities and regional presence their programmes require.
ACGMP will launch at the Cell & Gene Meeting on the Mesa in Phoenix.
Its founding members are convening an invitation-only gathering for developers on Tuesday, October 6.
Patient advocate Brad Watts will open the gathering by speaking about global access to therapies, the theme of the alliance, followed by a discussion of manufacturing challenges. The gathering will also support the Emily Whitehead Foundation.
The alliance is intended to support developers from early process development through scale-up and commercial manufacturing.
Its members’ capabilities span autologous and allogeneic cell therapies, gene therapies, and include viral vectors, RNA, lipid nanoparticles, plasmid DNA and apheresis starting materials.
ACGMP also plans to develop shared quality and technology transfer tools, including quality agreements, pre-audits and site visits, and to create opportunities for member technical and quality teams to work together.
“Great therapies should not stall at a border,” said Bev Menner, CEO, Cell Therapies Pty, an ACGMP founding member.
“The rapid growth of the cell and gene therapy sector has brought impactful therapies to individual markets, but barriers to global commercialization have left too many patients behind. Collaboration among specialist manufacturers can help developers address the complexity of bringing these therapies to more regions.”
The founding member organisations are Cell Therapies in Melbourne, eXmoor Pharma in the UK, Nucelion Therapeutics in Hyderabad, Siam Bioscience in Bangkok, SCTbio in Prague, Teijin REGENET in Tokyo and Xellera in Hong Kong.
ACGMP is seeking additional members, including in the United States and China.
