This eight-week evening certificate program is taught by WPI instructors and biomanufacturing industry professionals. It includes a mix of classroom instruction and hands-on learning in small teams working on state-of-the-art biomanufacturing equipment.
Once the hands-on processing section of the course begins, participants will be divided into small groups. These groups will rotate through the appropriate unit operations, each led by an instructor who is a subject matter expert from industry. The unique design of this certificate program features not only learning the technical and scientific principles of each unit operation, but also performing each operation under simulated cGMP conditions.
This program has been designed to allow the participants to network with the instructors, who are subject matter experts. Some of these instructors are also hiring managers from biomanufacturing organizations who need to employ trained and skilled individuals to enhance their workforces.
- Performing activities in compliance with the cGMP’s (Current Good Manufacturing Practices) that are mandated by the FDA (Food & Drug Administration)
- A tour of AbbVie in Worcester
- Operation of critical equipment and instruments such as bioreactors, purification columns, harvesting equipment (centrifuges, depth filters, etc.) biosafety cabinets and analytical instruments
- Experience single-use and stainless steel equipment
- Following Standard Operating Procedures (SOP’s) for these operations
- Completing production batch records
- Filling out equipment checklists and logs
- Demonstrating conduct in compliance with FDA regulations and expectations
Attendees actively participate in a full biomanufacturing process that includes the following unit operations:
- Cell culture operations
- Media preparation/seed inoculums
- Aseptic processing in biosafety cabinet
- Buffer preparation
- Tangential flow concentration and diafiltration
- Purification process (column chromatography)
- Column packing and qualification
- Filtration and integrity testing
- Analytical instrumentation and lab calculations
- Next Program: Starting September 23, 2019
- Days: Schedule will be provided
- Time: 5:00 p.m. to 9:00 p.m.
- Location: Biomanufacturing Education & Training Center
WPI Gateway Park, 50 Prescott Street (2nd floor), Worcester, MA
- Cost: $5000
- CEU: 9.2
Prerequisites: Participants must be able to read and write English, have basic Math skills and possess a High School Diploma. Successful passing of a mechanical aptitude assessment test is required in order to be admitted to the program. Additional details of the assessment will be provided upon submitting registration.
Payment in full must be received in order to be admitted into the program.