Professor Menegatti to Lead NCSU Multidisciplinary Research Team

Professor Stefano Menegatti will lead a team of NC State researchers in a collaborative, multi-institutional project funded by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL***). The NC State team comprises researchers in the Departments of Chemical and Biomolecular Engineering, and Biochemistry, and the Golden LEAF Biomanufacturing Training and Education Center (BTEC).

The project, entitled “Identification, Characterization and Removal of
Host-Cell Proteins (HCP) in Chinese Hamster Ovary (CHO) Monoclonal
Antibody Biomanufacturing Processes”, focuses on developing novel,
continuous methods for the purification of therapeutic antibodies, and
has received a total funding of about $2.5M, of which $1.1M is awarded
to NCSU. The research effort will involve three universities:
University of Delaware (Lead institution), NC State and Rensselaer
Polytechnic Institute; and two major biopharmaceutical companies,
Genentech and Merck.

Monoclonal antibodies (mAbs) are the clinical workhorse in the fight
against cancer, autoimmune diseases (e.g., rheumatoid arthritis), and
degenerative disorders (e.g., Alzheimer), owing to their high
selectivity and efficacy. In the current industrial manufacturing,
mAbs and mAb-related products are produced by engineered Chinese
Hamster Ovary (CHO) cells, followed by purification using high
affinity adsorbents. However, CHO cells secrete – together with the
mAb product – a number of contaminants, called “host cells proteins”
(HCPs), which must be carefully removed (> 99.99%) to avoid adverse
effects in patients.

Recent discoveries on mAb expression by CHO cells have revealed the
presence of “difficult” contaminant HCPs, that either degrade the mAb
product or escape the series of purification steps. Further, a current
trend prevailing in biomanufacturing is pushing the field towards
“continuous processing”, due to expected reduced operation costs and
higher productivity. This research effort aims to combine this novel
paradigm into a novel technology that enables the removal of
contaminant HCPs, especially focusing on the “difficult” species, in a
continuous mode, to accelerate the production of therapeutics at lower
cost for the patients.

***NIIMBL is the recently-funded National Institute for Innovation in
Manufacturing Biopharmaceuticals. Its mission is to accelerate
biopharmaceutical manufacturing innovation, support the development of
standards that enable more efficient and rapid manufacturing
capabilities, and educate and train a world-leading biopharmaceutical
manufacturing workforce, fundamentally advancing U.S. competitiveness
in this industry.