Ensuring quality is a key challenge for the goal of delivering revolutionary biotherapeutics to the patients who need them. This Summit explores how a broad range of stakeholders are advancing their ability to ensure the quality of these innovative product modalities.

MIT’s Center for Biomedical Innovation will host the 2023 BioMAN Summit, which brings together thought leaders from industry, academia, and government for a series of invited presentations to investigate:

• What process designs are being used to maintain key product quality attributes of complex biologic products and to minimize introduction and formation of process- and product-related impurities?
• How are manufacturers ensuring safety of novel product modalities when traditional unit operations such as affinity purification, filtration, and viral inactivation cannot be used?
• What analytical platforms are being developed to provide rapid measurement of critical process parameters and product quality attributes?
• How are manufacturers approaching setting specifications for their complex biologic products?
• How are manufacturers addressing the impact of raw materials and supply chain characteristics on product quality attributes for these products?
• What efforts are underway to digitalize quality control and quality assurance for these products?

The BioMAN Summit is made possible by these event sponsors: