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Cellular starting material in ATMP manufacturing A challenge that many developers of ATMP products are faced with is the selection and qualification of starting material. The large diversity of ATMP products requires a tailored strategy for each product, whether you are working on an autologous or allogeneic cell product, a gene engineered product or expanded continue reading…
Antibody-drug conjugates (ADCs) are currently at the forefront of the drug development revolution occurring in oncology delivering on the long-standing promise of a highly effective and selective cancer treatment. They are among the fastest-growing drug classes in oncology with a remarkable surge in marketing approvals in recent years. Nine ADCs were FDA approved from 2017 continue reading…
The proof-of-concept studies have shown promising results and bring a therapy a step closer to the clinic. But what is needed before this therapy can show its efficacy in a clinical trial? Cell therapy is a promising treatment, but its development is challenging due to its complex technology and the regulatory framework in which it continue reading…
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