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 Control Biochemistry
- The Quality Control Biochemistry unit of the NBC2 global biomanufacturing curriculum provides curricular material for conducting Quality Control Biochemistry assays required by the FDA for production of biologics.
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TEXTBOOK CHAPTER
- Quality Unit Overview
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SOPs
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ELISA Assays
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⇰ Quantitation of CHO DP-12 Derived Anti IL-8 Monoclonal Antibody by ELISA SOP
- ⇰ Human tPA Activity ELISA Kit SOP
- ⇰ Human tPA Total Antigen ELISA KIT SOP
- ⇰ HSA ELISA SOP
- ⇰ Operation of BioTek Elx 8080UI Automated Microplate Reader SOP
- ⇰ Operation of BioRad iMark Microplate Absorbance Reader SOP
- HPLC Analysis
- ⇰ Monoclonal Antibody Aggregate Testing by HPLC Analysis SOP
- ⇰ Quantification of Caffeine in Coffee using HPLC SOP
- ⇰ Characterization of GFP using BLC-30G HPLC System SOP
- ⇰ Buck Scientific BLC-20P HPLC Operation SOP
- ⇰ Buck Scientific BLC-30G HPLC Operation SOP
- ⇰ Degassing a Solution by Helium Sparge SOP
- Upstream Quality Control
- ⇰ Glucose Determination Assay Using Spectrophotometry SOP
- ⇰ Lactate Determination Assay Using Spectrophotmetry SOP
- ⇰ Glucose and Lactate Concentration Determination using the YSI 2900 Biochemistry Analyzer SOP
- ⇰ Oakton PC 700 Bench Series pH/ Conductivity/°C/°F Meter SOP
- ⇰ Trypan Blue Assay for Cell Viability Determination SOP
- Downstream Quality Control
- ⇰ Fisher Scientific Vertical MiniGel System SOP
- ⇰ SDS-PAGE Protein Gel Electrophoresis SOP
- ⇰ Quantitation of CHO DP-12 Derived Anti IL-8 Monoclonal Antibody by ELISA SOP
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- Introduction to Biomanufacturing Master Glossary
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BioTek Elx 8080UI Automated Microplate Reader SOP
SOP from CHO Cell - tPA Core Production Manual
Buck Scientific BLC-20P HPLC Operation
SOP developed by Montgomery County Community College
Buck Scientific BLC-30G HPLC Operation
SOP developed by Montgomery County Community College
Chapter 9: Quality Control Biochemistry
Chapter 9 of Introduction to Biomanufacturing
Characterization of GFP using BLC-30G HPLC System
SOP developed by Montgomery County Community College
Degassing a Solution by Helium Sparge
SOP developed by Montgomery County Community College
Quality Unit Overview for chapters 7-9 of Introduction to Biomanufacturing
View File