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Custom Programs

industry class in BTEC's large-scale downstream suite

Every organization has different training requirements. Some need theory and fundamentals, while others need hands-on laboratories. BTEC can develop and deliver the right course specific to individual company needs in its comprehensive biomanufacturing training facility which features bench-scale and simulated cGMP pilot-scale labs furnished with the latest industry-standard equipment. Get job-focused training led by industry experienced instructors in areas such as microbial fermentation, animal cell culture, downstream bioprocessing, quality control and analytical testing, single-use technologies, current Good Manufacturing Practice, and bioprocess development and engineering.

BTEC has designed and delivered customized programs for biomanufacturing companies, suppliers, regulatory agencies, and educators from other institutions. Courses have utilized multiple delivery strategies (e.g., hands-on, online modules, off-site lectures) and have covered a range of topics including hands-on biomanufacturing, cell culture engineering, fermentation, downstream process development, automation, single-use processing, formulation science, and other specialized topics, including vaccine manufacturing. If your company is interested in learning more about such opportunities, please contact Erica Vilsaint at embrown4@ncsu.edu or read on.

Biopharmaceutical manufacturers

BTEC frequently partners with biopharmaceutical manufacturing companies around the world to design programs for a range of personnel, including process development teams, manufacturing associates, and quality assurance personnel.

Suppliers and vendors

BTEC also routinely designs and delivers courses focused on educating equipment suppliers and vendors about the biopharmaceutical industry. With hands-on manufacturing training, sales, marketing, and field application personnel from such organizations are better able to understand their customers’ challenges and recognize opportunities for mutually beneficial partnerships.

Federal agencies

BTEC has a successful track record of working with federal agencies to provide specialized training programs in biomanufacturing. Of particular note is a five-year program completed for the Biomedical Advanced Research and Development Authority (BARDA) and our training partnership with the U.S. Food and Drug Administration (FDA), which is described below.

U.S. FDA

From 2008–2019, BTEC partnered with the FDA Office of Regulatory Affairs (ORA) to provide 169 of its professional staff with a series of four hybrid courses consisting of both online and on-site training. In 2021, the FDA awarded BTEC a new one-year training contract, which may be extended for an additional four years. For this new contract, beginning in May 2022 BTEC will deliver either virtual (online only) or hybrid (combined online and on-site) versions of the same four courses:

  • Upstream Bioprocessing
  • Downstream Bioprocessing
  • Quality Control/Analytical, and
  • Aseptic Processing

A 15-person cohort of personnel will participate in the courses, which are offered sequentially and enable FDA investigators to gain an increased understanding of key biomanufacturing principles and processes. Participants include pharmaceutical/biopharmaceutical inspectors and field personnel—primarily consumer safety officers, scientists, drug specialists, and investigators.

In addition, from 2017–2019 BTEC delivered a similar three-course training program to personnel from the FDA's Center for Drug Evaluation and Research (CDER).