
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.
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:

Application
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?

Challenges
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?
Speakers
Details will be available soon. Please check back for updates!
PROGRAM
Details will be available soon. Please check back for updates!
Day 1
Day 2
Please check back later for a downloadable version.
REGISTRATION
The deadline for the Summit registration is November 19th!
Please reach out to Lola Atitebi if you are interested in receiving applicable member discount rates or other pricing questions.

Venue
The Summit will be held at the Samberg Conference Center, Building E52, 50 Memorial Dr, Cambridge, MA 02142
Sponsors
The Summit is made possible by our BioMAN Consortium Members: