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Reducing Door-to-Floor: Improving Readiness of New Hires through cGMP Hands-on Biopharmaceutical Training

We will immerse trainees in a rigorous digital and hands‐on training program, comprised of more than one hundred (100) hours of cGMP‐ and regulatory‐based curricula
Categories
Incumbent worker training
Project status
100% Completed

Solution

Performance Period: 8/15/2018 to 2/15/2020

To address the significant pipeline deficiency of a readily‐available skilled workforce in the biopharmaceutical manufacturing industry, Texas A&M Engineering Experiment Station (TEES) will train forty (40) university and community college students, career changers, and military veterans to become biomanufacturing professionals. “Door‐to‐Floor” is a Manufacturing Readiness Level (MRL) 7 project with the goal to significantly diminish the time it takes for a new hire to add value in their job as biologics manufacturing technicians and engineers. We will immerse trainees in a rigorous digital and hands‐on training program, comprised of more than one hundred (100) hours of cGMP‐ and regulatory‐based curricula, including aseptic cell processing using fixed and single‐use fermentation and purification systems, quality management systems, proper documentation practices, and advanced cell therapy bioprocessing curriculum developed in conjunction with PBS Biotech.

Participants will complete five (5) asynchronous online courses, and then participate in two (2) full weeks of hands‐on training at the National Center for Therapeutics Manufacturing (NCTM) in College Station, Texas. Upon completion, the “Door‐to‐Floor” project will be at MRL 8, and its technically‐skilled graduates will be ready for immediate employment with National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) industry partners.

Updates, Related Publications, and Deliverables

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Project Lead

Texas A&M University System

Texas A&M University System

Participating Organizations

Akron Biotechnology, LLC

Akron Biotechnology, LLC

Vericel Corporation

Vericel Corporation

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