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At-Bioreactor Trace Metal Quantification and Statistical Process Control in CHO Cell-culture Production

The goals of this project are 1) to develop an offline assay for trace metal quantification and 2) to develop an at-reactor trace metal quantification instrument towards improved monitoring and control of critical trace metals in cell-culture production.
Categories
Proteins/ Antibodies
Drug substance
Assays
Project status
100% Completed

Solution

Performance Period: 12/1/2018 to 8/31/2020

While there are relationships between CHO cell growth/productivity and the metals composition of the medium, studies to date have not yielded universally applicable conclusions. Once quantified accurately and in real-time, metals composition could become a useful control parameter. To this end, researchers at UMass Lowell along with US FDA (CDER) are studying of the roles of trace metals, (Cu, Mn, Se, and Zn) in CHO cell culture production and are developing an offline assay for trace-metal quantification. In order to closely monitor and control critical trace metals in cell-culture production, real-time (or near real-time) instrumental methods need to be in place that provide such analyses, preferably on simplified platforms that can be implemented at-reactor. This can be particularly useful in continuous processing environments.

Clemson University has developed the liquid sampling-atmospheric pressure glow discharge (LSAPGD) microplasma as a simple, sensitive ionization source for elemental analysis. Uniquely, the device can be implemented on small-footprint LC-MS platforms. As such, the need for “remote” or off-line analyses on core facility ICP-MS systems may be alleviated. Proof of concept has been demonstrated in collaboration with Merck laboratories on a Waters (Billerica, MA) QDa platform, but other manufactures also offer systems which could be readily implemented on the production floor.

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Project Lead

Clemson University

Clemson University

Participating Organizations

Federal Stakeholder: Food and Drug Administration

Federal Stakeholder: Food and Drug Administration

Massachusetts Life Sciences Center

Massachusetts Life Sciences Center

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

University of Massachusetts Lowell

University of Massachusetts Lowell

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