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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 John Balchunas at jebalchu@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. A recent article in BioProcess International provides an example about one ongoing partnership with Sanofi.

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 nearly 10-year training partnership with the U.S. Food and Drug Administration (FDA), which is described below.

FDA’s Office of Regulatory Affairs (ORA)

BTEC has partnered with the FDA Office of Regulatory Affairs (ORA) since 2008. Each year, a new 15-person cohort of personnel begin a series of four hybrid courses consisting of online and on-site training. The personnel include pharmaceutical/biopharmaceutical inspectors and field personnel—primarily consumer safety officers, scientists, drug specialists, and investigators. Each of the four courses in the program begins with a four-week online component and concludes with several days of intensive hands-on training at the BTEC facility. Online instruction focuses on the conceptual and theoretical knowledge associated with the course topics, while on-site instructional activities are largely experiential and take place throughout the BTEC facility. The courses—Quality Control/Analytical, Upstream Bioprocessing, Downstream Bioprocessing, and Aseptic Processing—enable FDA investigators to gain an increased understanding of key biomanufacturing principles and processes.

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FDA’s Center for Drug Evaluation and Research (CDER)

With a program that began in July 2017, BTEC is providing a three-course program to personnel from the FDA's Center for Drug Evaluation and Research (CDER). Similar to the ORA training program (see above), a group of 12 professionals from CDER will complete three blended (part online/part on-site) courses during 2017–2018. A second cohort is scheduled for 2018–2019.

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