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
Microbiological Control
- The Microbiological Control unit of the NBC2 global biomanufacturing curriculum provides curricular materials for microbial assays and gowning for entry into a biomanufacturing suite.
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TEXTBOOK CHAPTER
- Chapter 8: Microbiological Control
- Quality Unit Overview
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SOPs
- Microbial Assays
- ⇰ API 20E Microbial Identification SOP
- - API 20E Manufacture Instructions
- - API 20E Examples of Positive & Negative Tests
- ⇰ Gram Stain SOP
- ⇰ LAL Assay Gel Clot Method SOP
- ⇰ Mycoplasma Testing SOP
- Environmental Monitoring & Gowning
- ⇰ Gowning for Entry into Biomanufacturing Suite SOP
- ⇰ Operation of MetOne Model 299B Laser Particle Counter SOP
- ⇰ M Air T Millipore Air Tester SOP
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Skill Standards
- Quality Control Microbiology Skill Standards
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- Other Resources:
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VIRTUAL LABS
- Autoclave Operation
- Environmental Monitoring
- By NC BioNetwork
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VIDEO
- Gowning (15 minutes)
- by NC BioNetwork
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- Introduction to Biomanufacturing Master Glossary
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API 20 E Instructions
Instructions for API 20 E strips
API 20 E Legend
Legend for interpreting API 20 E results
API 20E Microbial Identification SOP
SOP from BIOMAN QC Microbiology workshop.
Autoclave Operation
In this interactive lesson from BioNetwork covers an overview of the autoclave, review safety considerations and provides a virtual opportunity...
Chapter 8: Microbiological Control
Chapter 8 of Introduction to Biomanufacturing
Environmental Monitoring
Interactive module from BioNetwork- Environmental Monitoring is a challenging and serious game which places you in a virtual cleanroom, tasked with...
Quality Unit Overview for chapters 7-9 of Introduction to Biomanufacturing
View File