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Introduction As pharmaceutical drugs become physically larger, from small molecules to biologics to gene and cell therapies, so their molecular complexity increases. Small molecule drugs can be defined at the atomic level: it is known where each atom should be and how it should be connected to others. Methods are therefore developed to measure and continue reading…
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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