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 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.

MIT’s Center for Biomedical Innovation will host the 2025 BioMAN Summit, which brings together thought leaders from industry, academia, and government for a series of invited presentations to investigate:

• What paradigms can be adopted from traditional mAb manufacturing and what unique challenges must be overcome?

• How do drug development and process development work together to ensure manufacturability of these novel modalities?

• What are the outstanding gaps in analytical technologies needed to assess product quality for these modalities?

• How are the novel formulation challenges being addressed?

• What approaches are manufacturers taking to solve the cold chain challenges?