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Biotechnology Manufacturing Business Training Enterprise

BIOMAN 2014 offers GMP training environment, practical industry-relevant training, and product manufacturing to enhance biotechnology instruction. Collaborative efforts in biomanufacturing, business, and marketing benefit student interns and customers. The journey from DNA extraction kits to prototype products and ISO 13485 quality standards is documented, with focus on product development, manufacturing, and quality management in biotechnology. The partnership with InnovaBio and STUDENTfacturED underscores the importance of restructuring, staff resources, R&D, and quality control measures.

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Biotechnology 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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