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Developing Directive Documents for Adoption of the NISTCHO Cell Line for Biomanufacturing Workforce Training

This project will develop Standard Operating Procedures (SOP) and batch records for the growth of the new NISTCHO Clonal CHO-K1 Cell Line (RGTM 10197) and production of the cNISTmAb in biotechnology training programs.
Categories
Proteins/ Antibodies
Drug substance
Talent/ Pipeline development

Industry Need

Despite the excitement surrounding the applications of nucleic acid-based vaccines, CAR-T cells, stem cells, and the production of viruses that serve as gene therapy vectors, monoclonal antibodies will remain the dominant biopharmaceutical product for the next decade. Applications for these useful molecules will continue to expand in therapeutics and diagnostics, and the demand for workers who can grow production cell lines will increase. During the recent coronavirus pandemic, companies struggled to find talent with cell culture experience. The United States must dramatically expand the talent pipeline to prepare for future pandemics.


Currently, few colleges in the United States give their students the experience of growing Chinese Hamster Ovary (CHO) cells engineered to produce monoclonal antibodies. This project intends to change that situation by using tools recently developed by the National Institutes of Standards and Technology (NIST) and the National Institute for Innovation in the Manufacture of Biopharmaceuticals (NIIMBL). 


Solution

•Successfully created thaw, maintain, and banking SOPs for NISTCHO

•Developed Biomanufacturing curriculum for use of NISTCHO in training and education

•Updated Biomanufacturing.org website, for distribution of protocols, SOP, batch records, representative data

•Completed undergraduate research projects with NISTCHO

•Publicized NISTCHO at every opportunity (local and national meetings); half of NISTCHO distribution was to colleges


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Project Lead

Montgomery College

Montgomery College

Participating Organizations

Montgomery County Community College

Montgomery County Community College