Category: CMC

Antibody-drug conjugates: targeted cancer therapies coming of age

Bert-Jan Haijema Gert Barf CMC Antibody-drug conjugates, ADCs

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…

Cell Therapy: Towards a First-in-Human Trial

Steven Braem

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…