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
Key Takeaways
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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.
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Brazil’s regulator, Anvisa, will provide regulatory oversight on the project to ensure compliance with cGMP and ATMP regulations
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