Manufacturing Challenges for Novel Antibody-based Modalities
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. Eleven bsAbs have been approved for hematological cancers and select solid tumors. 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, fourteen 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.
This Summit will explore topics such as:
•What paradigms can be adopted from traditional mAb manufacturing and what unique challenges must be overcome?
•What are the outstanding gaps in analytical technologies needed to assess product quality for these modalities?
•How do drug development and process development work together to ensure manufacturability of these novel modalities?
•How are the novel formulation challenges being addressed?
•What approaches are manufacturers taking to solve the cold chain challenges?
The 2025 BioMAN Summit will bring together leading experts from industry, academia, and regulatory agencies to address the pressing manufacturing challenges of novel antibody-based modalities.
Stay tuned—registration will open soon. Be sure to check back for updates and to reserve your spot.