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A Biotechnology-based Manufacturing Business-Training Enterprise

A Biotechnology-based Manufacturing Business-Training Enterprise. Vivian Ngan-Winward, Chloe Cigarroa, Mary Nelson BIOMAN 2014 – July 14-17. DUE-1003292. Create a “ regulated / GMP ” training environment Offer industry-relevant practical training

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A Biotechnology-based Manufacturing Business-Training Enterprise

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  1. A Biotechnology-based ManufacturingBusiness-Training Enterprise Vivian Ngan-Winward, Chloe Cigarroa, Mary Nelson BIOMAN 2014 – July 14-17 DUE-1003292

  2. Create a “regulated / GMP” training environment Offer industry-relevant practical training Manufacture products that support / enhance biotechnology instruction Purpose

  3. Idea • Research & Development • [‘Proof of Concept’] • Prototyping / Pilot Plant [Validation & Smaller Scale Production] • Manufacturing • [Mass / Large Scale Production] • Consumer Product Lifecycle GMP Regulations

  4. Student interns Buyers of product & their students Customers

  5. A collaboration Biomanufacturing / Biotechnology Accounting Business Management Marketing Faculty mentors& student interns In the Beginning . . .

  6. Cheek cell DNA extraction kit Assessment plasmid – coded unknown samples First Products

  7. Student work pace = slow! Student enrollment low Business students/faculty do not understand biotechnology Cost-effective instructional supplies vs. business philosophy differences Lessons Learned

  8. School of Business withdrawal Partnership with InnovaBio • = product development (R&D) • = manufacturing Full quality management system • Based on ISO 13485 (for medical device) • Facilitates “GMP compliance” MasterControl : management software STUDENTfacturED 2.0

  9. Partnership = Restructuring Director of InnovaBio Director of STUDENTfacturED STUDENTfacturED full-time staff (1) What’s Happening Now InnovaBio full-time staff (2) InnovaBio part-time staff InnovaBio student interns STUDENTfacturED student interns R&D Manufacturing

  10. QMS Completion a la ISO 13485 What’s Happening Now

  11. QMS show & tell • Quality manual • Design Control SOP & Form What’s Happening Now

  12. New product development under design control – per 21 CFR 820.30 What’s Happening Now

  13. New ladder DNA ladder 2-log ladder New Product bp: 500 400 300 (2x) 200 100 *

  14. Management of • Documents • Training • Suppliers • Changes • Nonconformances / complaints • CAPA • Audits • Risk MasterControl Software

  15. Curriculum adjustments New product ideas Logistics for product sales ??? Next Steps

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