2025 BioMAN Summit

Bi-specific antibodies (bsAbs) represent a novel approach to cancer therapy by simultaneously targeting two distinct antigens—either linking immune cells to tumor cells or blocking dual signaling pathways. As of December of 2024, fourteen bsAbs have been approved by the FDA. However, their complex structure as IgG heterodimers presents significant manufacturing and quality control challenges, particularly around purification and aggregation.​

​Antibody-drug conjugates (ADCs) combine monoclonal antibodies with chemotherapy drugs to deliver targeted cancer treatment with fewer side effects. As of January 2025, thirteen ADCs have received FDA approval. Manufacturing challenges stem from scaling up both components and ensuring the stability of the linker that connects them. Like bsAbs, ADCs also pose difficulties for quality control assays.​