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TRANSCRIPT
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A Biotechnology-based Manufacturing
Business-Training Enterprise
Vivian Ngan-Winward, Chloe Cigarroa, Mary Nelson
BIOMAN 2014 – July 14-17DUE-1003292
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Purpose
• Create a “regulated / GMP” training
environment
• Offer industry-relevant practical
training
• Manufacture products that support
/ enhance biotechnology instruction
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Product Lifecycle
Idea
Research & Development
[‘Proof of Concept’]
Prototyping / Pilot Plant
[Validation & Smaller Scale
Production]
Manufacturing
[Mass / Large Scale
Production] Consumer
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Regulations
GMP
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Customers
1. Student interns
2. Buyers of product & their students
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In the Beginning . . .
A collaboration
• Biomanufacturing / Biotechnology
• Accounting
• Business Management
• Marketing
Faculty mentors & student interns
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First Products
• Cheek cell DNA
extraction kit
• Assessment plasmid
– coded unknown
samples
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Lessons Learned
• Student work pace = slow !
• Student enrollment low
• Business students/faculty do not
understand biotechnology
• Cost-effective instructional supplies
vs. business philosophy differences
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STUDENTfacturED 2.0
• 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 software8
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What’s Happening Now
• Partnership = Restructuring Director of InnovaBio Director of STUDENTfacturED
InnovaBio full-time staff (2)
InnovaBio student interns
InnovaBio part-time staff
STUDENTfacturED full-time staff (1)
STUDENTfacturED student interns
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R&D ManufacturingR&D Manufacturing
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What’s Happening Now
• QMS
Completion
a la
ISO 13485
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Quality Manual
Document Control
Design Control
Nonconformances
Quality Event
Mgmt /
CAPA
Complaint Handling
Risk Assessmt
/ Mgmt
Training
Audits
Supplier Mgmt
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What’s Happening Now
• QMS show & tell Quality manual
Design Control SOP & Form
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What’s Happening Now
• New product development under
design control – per 21 CFR 820.30
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New Product
• DNA ladder 2-log
ladder
*
bp:
500
400
300 (2x)
200
100
New
ladder
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MasterControl Software
• Management of Documents
Training
Suppliers
Changes
Nonconformances / complaints
CAPA
Audits
Risk14
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Next Steps
• Curriculum adjustments
• New product ideas
• Logistics for product sales
• ???
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