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.

Approach

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). This project provided solutions by

  • Developing a biomanufacturing curriculum using NISTCHO cells to teach biomanufacturing and biotechnology skills
  • Publicizing NISTCHO as an undergraduate teaching/research tool
  • Conducting undergraduate research using NISTCHO cells

Impacts

The NISTCHO cell line was publicized as a useful tool for teaching cell culture, biomanufacturing, and cell biology in college/university settings. Cell culture, aseptic technique, and biomanufacturing skills are foundational for pandemic preparedness.

Value Statement/Outcomes

The project delivered measurable outcomes including an updated biomanufacturing curriculum hosted on Biomanufacturing.org, featuring validated SOPs, batch records, and sample data for NISTCHO-based processes. Training reached 36 participants—including 26 higher-education students and 5 professionals—who mastered critical biomanufacturing skills through hands-on experience with shake flasks, bioreactors, and chromatography systems. Additionally, the project demonstrated that NISTCHO cells can be banked at -80°C for at least six months without loss of viability, reducing costs for educational institutions and enabling sustained training programs. These outputs provide immediate, scalable value to NIIMBL members and the broader industry by offering a proven, cost-effective platform for workforce development and pandemic readiness.

Outputs/Deliverables

Integrated Curriculum: Incorporates NISTCHO Research Grade Test Material into a freely accessible biomanufacturing curriculum, validating it as a robust, easy-to-use cell line for teaching upstream and downstream processes.

Industry-Relevant Skills: Prepares students with essential skills—aseptic technique, cell culture, protein purification, and Good Documentation Practices—critical for biopharmaceutical production and pandemic preparedness.

Benefits to Stakeholders: Provides NIIMBL members with a standardized, scalable training resource to address workforce gaps, while giving educators ready-to-implement protocols and batch records for practical instruction.

Workforce Impact: Strengthens the biopharma talent pipeline by ensuring graduates are prepared for GMP roles in manufacturing vaccines, therapeutics, and diagnostics.

Publications

Nadour, S., Clement, K., Doshi, H., & Bryans, M. (2024). Assessing the Stability of NISTCHO Cells in Long-Term Culture. Journal of Advanced Technological Education, 3(2), 81–88. https://doi.org/10.5281/zenodo.13546664

Posters

Bryans, M., Kelman, L., Poster participant, NIIMBL WAC Meeting, Sept 21, 2023.

Cathlin, N., Geddes, E., Kelman, L., Doubling Times of NISTCHO Cells Banked at Different Temperatures. Maryland Collegiate STEM Conference. Montgomery College, Rockville, MD, Apr 20, 2024

Dev, N., Ananthanarayanan, M., Kelman, L., Comparison of cNISTmAb Production in NISTCHO Cells Grown with Two Different Media, Maryland Collegiate STEM Conference, Montgomery College, Rockville, MD, Apr 20, 2024.

Kelman, L., Conference Participant, ARP-38: Use of NISTCHO as a teaching and training tool for biomanufacturing, NIIMBL National Meeting, Washington, D.C., June 26, 2025.

Shams, G., Alasady, J., Ananthanarayanan, M., Kelman, L., Additional Supplementation of Feed 1 Results in Increased IgG Production by NISTCHO Cells, Maryland Collegiate STEM Conference, Montgomery College, Rockville, MD, Apr 20, 2024.

Slotta, T., Ananthanarayanan, M., Kelman, L., NISTCHO Cells Can Be Stored at -150oC and -80oC but not -20oC, Maryland Collegiate STEM Conference, Montgomery College, Rockville, MD, Apr 20, 2024.

Smerin, S., Ananthanarayanan, M., Kelman, L., Culturing of a monoclonal antibody CHO cell, Maryland Collegiate STEM Conference, Montgomery College, Rockville, MD, Apr 20, 2024

Tasnim, A., Swaminathan, S., Ananthanarayanan, M., Kelman, L., Examination of NISTCHO Seeding Density in EX-CELL Fusion Medium, Maryland Collegiate STEM Conference, Montgomery College, Rockville, MD, Apr 20, 2024

Presentations

Bryans M, Kelman L., Greenwell R, Doshi H., Ezeala C., Prabhakar S., Weis-Garcia F, Wilson C, Romano E., & Carson V. Presenters, NISTCHO Cells and CNISTmAb, Presented at the Antibody Hackathon 2023 online, Aug 7-10, 2023.

Bryans, M., Kelman, LM., Presenter, NISTCHO Cells for Teaching Biomanufacturing and Undergraduate Research, Webinar, May 29, 2024.

Day, R., Cao, S., Slotta, T., Villavicencio, E., Suvorov, M., Ananthanarayanan, M., Gold, P., Kelman, L., NISTCHO Cells Can be Banked Short-Term at -80oC but not at -20oC. AMBIC Winter Meeting. Clemson University, SC. Jan 11 2024.

Day, R., Presenter, Assessment of Stability of NISTCHO Cells Cryogenically Preserved at -20oC and -80oC. Maryland Collegiate STEM Conference. Montgomery College, Rockville, MD, Apr 20, 2024.

Jones, C., Presenter, MC Biotech update to Montgomery College Board of Trustees, Montgomery College, Nov 13, 2023

Kelman L. Presenter, Preparing the Entry-Level Cell and Gene Therapy Workforce. Presented at Inaugural DMV Cell and Gene Therapy Symposium. Children’s National Hospital, Washington DC, Nov 02, 2023.

Kelman, L., NISTCHO and Undergraduate Education: Undergraduate Research and a Biomanufacturing Curriculum, Maryland Collegiate STEM Conference, Montgomery College, Rockville, MD, Apr 20, 2024.

Kelman, LM., Presenter, NISTmAb and NISTCHO, Montgomery College Biotechnology Lunch and Learn, Germantown, MD, Oct 16, 2023.

Kelman, LM., Presenter, NISTmAb and NISTCHO: Reference Materials for the Biopharma Industry, Presented at the Antibody Hackathon 2023, online August 7-10, 2023.

Swaminathan, S., Presenter, Production of cNISTmAb by NISTCHO in Shaker Flask Culture, Maryland Collegiate STEM Conference, Montgomery College, Rockville, MD, Apr 20, 2024.

Wall, W., Effect of Additional Feed 1 Supplementation on NISTCHO Cell Growth and IgG Production, Maryland Collegiate STEM Conference, Montgomery College, Rockville, MD, Apr 20, 2024.

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Project Lead

Montgomery College

Montgomery College

Participating Organizations

Montgomery County Community College

Montgomery County Community College