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How The EU, US & Brazil Are Shaping Decentralized Manufacturing For ATMPs

 
• By Eliza Slawther

Regulators in Europe and the US have demonstrated a commitment to providing guidance that will make decentralized and point-of-care manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.

GermFree Mobile Cleanroom
A look inside one of GermFree's modular cleanrooms • Source: GermFree

Patients in need of advanced therapy medicinal products (ATMPs) face many access challenges, even in countries where the reimbursement of these innovative medicines is covered by national health insurance funding.

One major hurdle for both patients and pharmaceutical companies in the ATMP space is manufacturing, given that making autologous products such as CAR-T therapies involves taking cells from the patient...

Key Takeaways

  • GermFree, a mobile cleanroom company, has partnered with non-profit Caring Cross to bring point-of-care CAR-T manufacturing to patients globally, starting with Brazil.

  • Brazil’s regulator,...

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