BioMAN Activities – Research Area 1

Advanced product and process analysis for optimized quality manufacturing

MIT BioMAN is pursuing a platform of innovative technologies (sensors, high-throughput (HT) platforms, state-of-the-art microfluidic bioreactors, and new pre-clinical models) to enable a more relevant understanding of the critical factors determining the optimal and consistent production of biopharmaceuticals. By examining and correlating data collected across multiple scales—from molecules (sensors), to single cells (HT screening), to small populations of cells (microbioreactors), to large-scale bioreactors and in animal models, we aim to learn and integrate concepts that inform control strategies spanning development and manufacturing, and lay the foundation for the development of real-time, in-line process analytical tools for the production environment. The goal of Theme 1 is to develop a variety of new sensors, assays and technologies to enable deeper understanding of how critical parameters such as host cell line, or process conditions affect quality and productivity of therapeutic production and how these parameters impact biological activity and safety. Specific research programs in Theme 1 are focused on:
 

High-Throughput Clone Selection

BioMAN research is focused on high-throughput, single cell screening platforms for the deep phenotypic profiling of 105 – 106 cells per assay that will evaluate polyclonal populations of cells used in biomanufacturing for rates of production, antigen specificity and native structure, and variation in glycosylation.

 

New Sensors

BioMAN research is focused on new sensors for the real-time monitoring of intracellular and feedstock components as well as rapid and real-time profiling of glycosylation.

 

Microfluidic Bioreactors

BioMAN research is focused on microfluidic bioreactors for high-throughput, low-cost cell culture optimization capable of in-process detection of medium composition and imaging of single cells.

 

New Animal Models

BioMAN research is focused on the development of predictive single-cell assays and animal models for accelerated evaluation of a protein’s immunogenicity.