MCCC Biomanufacturing Course / 1.12 Montgomery County Community College Biomanufacturing Laboratory Manual 2nd Edition
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Keywords
Biomanufacturing, Biotechnology, Laboratory Exercises, Experiments, Standard, Operating, Procedure, SOP, Metrology, pH Meter, Conductivity, Balance, Calibration, Operation, Maintenance, Validation, Qualification, IQ, OQ, Autoclave, Environmental health and safety, Hazard, Communication, Audit, MSDS, Quality Assurance, Material Control, Production, Quality Control, Batch Record, Raw Material, Specification Sheet, Cleaning Log, Microbiological Control, Microbiology, Particle Counter, Gowning, Gram Stain, LAL Assay, Gel Clot, API, Microbial Identification, Mycoplasma, Testing SOP, Biochemistry, Upstream, Processing, CHO Cell, tPA, Biosafety Cabinet, Spinner Flask, Cleaning, Batch Culture, Bioreactor, Controller, Cell Counter, Assay, Trypan Blue, Downstream, Tangential Flow, Diafiltration, AKTA Pure, AKTA, Quality Control, Human tPA, Antigen, ELISA, Activity, Glucose, Lactate, Determination, Microplate, Absorbance, Reader, Degassing, Helium, Sparge, HPLC, Quantification, Caffeine, GFP, Quality, Characterization, Nanodrop, Spectrophotometer
Project
c3bc
Authors
McMillan, Jason
Bryans, Margaret
Buford, John
Frank, David
Date Submitted
2016-04-27
Material Type
Secondary Material Type
Institution
Industry Partner
N/A
License
CC BY
Funding Source
Additional Public Access
Abstract
"This learning object, 1.12 Montgomery County Community College Biomanufacturing Laboratory Manual 2nd Edition, is a laboratory manual for biomanufacturing. It is presented as a series of laboratory exercises as part of a biomanufacturing course, i.e., MCCC Biomanufacturing Course. These exercises provide a comprehensive foundation in the biomanufacturing process of biopharmaceuticals, with production under current Good Manufacturing Practices in a simulated cGMP laboratory environment. Learning exercises include the culture of mammalian cells to produce biological products using the tools of manufacturing, such as bioreactors for upstream processing, downstream processing, protein purification, and quality control. The laboratory exercises are SOP driven and include batch record documentation.
This learning object is associated with additional learning content in biomanufacturing that is provided as separate, supplemental material:
a) The eleven lectures, MCCC Biomanufacturing Course / 1.1 Introduction to Biomanufacturing to 1.11 Process Development, covering a series of topics intended for instructing a biomanufacturing course.
b) The MCCC Biomanufacturing Course / 1.13 Downstream Processing eLearning Modules html package. This educational tool utilizes text, figures, and video animations to detail the workflow, operations, and instrumentation involved in the batch production of a monoclonal antibody under cGMP conditions. The platform is packaged as a zip file and the learning object can be accessed and viewed with a web-browser (Google Chrome, Firefox, and Windows Explorer)
c) The MCCC Biomanufacturing Course / 1.14 Downstream Processing eLearning LMS SCORM package. This educational tool utilizes text, figures, and video animations to detail the workflow, operations, and instrumentation involved in the batch production of a monoclonal antibody under cGMP conditions. This SCORM is packaged as a zip file and is best accessed and viewed with a Learning Management System, LMS.
This grant product was created by the Community College Consortium for Bioscience Credentials and is licensed under a Creative Commons Attribution.
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