Biomanufacturing Units
Introduction to BiomanufacturingUpstream ProcessingDownstream ProcessingBiomanufacture of Cell and Gene TherapiesBiomanufacture of Monoclonal AntibodiesQuality AssuranceQuality Control BiochemistryMicrobiological ControlProcess DevelopmentManufacture of a Drug ProductFacilitiesMetrologyValidationEnvironmental Health & SafetyOperational ExcellenceBiofuels
mini-BIOMAN Conferences
miniBIOMAN 2021:Monoclonal Antibody Production: HighTech and Low Tech ApproachesminiBIOMAN 2019: Design of Experiments for BiomanufacturingminiBIOMAN 2019: Quality in BiomanufacturingminiBIOMAN 2018: Downstream Processing of mAbsminiBIOMAN 2018: Incorporating Undergraduate Research in Process DevelopmentminiBIOMAN 2017: Manufacture of a Drug Product - Final Fill Finishmini-BIOMAN 2017: Upstream Processing- Mab Production in CHO cellsmini-BIOMAN 2017: Single Use Technology in Biomanufacturingmini-BIOMAN 2016: Stem Cell Production in a Regulated Environment
Quality Assurance
- The Quality Assurance unit of the NBC2 global biomanufacturing curriculum provides curricular materials, activities and skill standards for training Quality Assurance technicians in the pharmaceutical industry.
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TEXTBOOK CHAPTER
- Chapter 7: Quality Assurance
- Quality Unit Overview
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Activity
- ⇰ Popcorn GMP Laboratory View PDF
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Skill Standards
- ⇰ Quality Assurance Skill Standards
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Presentations
- ⇰ Biopharmaceutical Quality by Cynthia Sarnoski
- ⇰ Quality Systems in Bioscience Manufacturing by Gretchen Ingvason
- Other Resources:
- VIDEOS
- ⇰ Making the Call: Quality in Biomanufacturing
- By Franklin Biologics
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VIRTUAL LABS
- ⇰ Current Good Maniufacturing Practices (CGMP)
- ⇰ Good Laboratory Practices (GLP)
- ⇰ Deliberate Documentation
- ⇰ Good Manufacturing Practices Interactive Module
- ⇰ Validation Fundamentals
- By NC BioNetwork
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- Introduction to Biomanufacturing Master Glossary
Allbiomanbioman 2013bioman 2015microbiological controlnewspresentationquality control biochemistryskill standardvalidation
BioNetwork's GLP Training Module
Interactive training module on Good Laboratory Practices (GLP) from BioNetwork
Biopharmaceutical Quality
PowerPoint slides from BIOMAN 2013, presented by Cynthia Sarnoski, member of the NBC2 National Visiting Committee and retired VP of Quality at Pfizer
Chapter 7: Quality Assurance
Chapter 7 of Introduction to Biomanufacturing
Deliberate Documentation
Interactive module from BiotNetwork showing how documentation is kept and used in a regulated manufacturing environment
Good Manufacturing Practices Interactive Module
Interactive Module from BioNetwork- Explore Good Manufacturing Practices (GMP) as you work through several interactive scenarios in a virtual...
Making the Call: Quality in Biomanufacturing
Making the Call: Quality in Biomanufacturing,” is an interactive educational video series developed by Bio-Link and Pellet Productions, Inc. that...
Quality Unit Overview for chapters 7-9 of Introduction to Biomanufacturing
View File