In the past decade, with the rapid development of cell therapies, the U.S. biopharmaceutical industry has made major advancements to cure some of society’s most devastating cancers and diseases. Unlike traditional or protein biopharmaceuticals, cell therapy manufacturing involves manipulating either the patient’s own cells – i.e. autologous therapy—or a donor’s cells
– i.e. allogenic therapy—to fight the disease. Yet, advancements in the commercialization of treatments and establishing large-scale manufacturing has been impeded due to workforce
shortages. Across the country, a lack of training programs that cater to incumbent workers in the cell therapy sector has slowed the workforce pipeline.
Working in concert with industry partners, Shoreline Community College in partnership with Bristol Myers Squibb, created a Cell Therapy Incumbent Worker Training Program. To develop the program, Shoreline convened a broad group of cell therapy companies to identify specific workforce gaps, challenges, and training needs. From those meetings, Shoreline developed training materials and curriculum, and then piloted training modules.
OUTPUTS
Topics Include:
• Controlled Documents Overview
• Standard Operating Procedure (SOP)
• User Privileges / Redlining
• Track Changes in WORD
• Language Used in SOPs
• Meeting the needs of a collaborator
• Batch Manufacturing / Production Records
Topics include:
• General equipment and sterile techniques
• Environmental monitoring
• Bioreactors (Upstream process overview)
• Column purification (Downstream process overview)
Increased efficiency and accuracy in cell therapy manufacturing, increased industry-wide awareness of cell therapies, increased capacity for companies to scale out the manufacturing process and decreased costs and amount of time for cell therapy companies
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Shoreline Community College
Bristol-Myers Squibb
