MCCC Biomanufacturing Course / 1.11 Process Development

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Keywords

Biomanufacturing, Biotechnology, Process Development, Expression, System, Process, Characterization, Validation, Viral, Inactivation, Viral clearance, Upstream, Downstream, Harvest, Optimization, Scale-up

Project

c3bc

Authors

Northeast Biomanufacturing Center & Collaborative

Date Submitted

2016-05-31

Material Type

Presentation

Secondary Material Type

Institution

Montgomery County Community College

Industry Partner

N/A

License

CC BY

Funding Source

TAACCCT Round 2

Additional Public Access

Abstract

"This learning object is a lecture (Power Point) on Process Development associated with the biomanufacturing process and is the eleventh in a series of eleven lectures for a biomanufacturing course. This object covers a variety of topics regarding process development relevant to the biomanufacture of biopharmaceuticals, including: an introduction to Process Development, Expression, System, Process, Characterization, Validation, Viral, Inactivation, Viral clearance, Upstream, Downstream, Harvest, Optimization, and Scale-up considerations. This lecture material was developed using the Introduction to Biomanufacturing textbook, Northeast Biomanufacturing Center and Collaborative, Published 2012. This learning object is associated with additional learning content in biomanufacturing that is provided as separate, supplemental material: a) The additional (ten) lectures covering a series of topics for a biomanufacturing course, MCCC Biomanufacturing Course / 1.1 Introduction to Biomanufacturing to 1.11 Process Development. b) The MCCC Biomanufacturing Course / 1.12 Montgomery County Community College Biomanufacturing Laboratory Manual 2nd Edition. This manual covers a variety of experiments relevant to biomanufacturing, is SOP driven, and includes batch record documentation. c) 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) d) 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. "

Industry (NAISC)

Professional, Scientific, and Technical Services -- Professional, Scientific, and Technical Services (541)

Occupation (SOC)

Life, Physical, and Social Science Occupations -- Biological Technicians (19-4021)

Instructional Program (CIP)

Biological and Biomedical Sciences (26)

Credit Type

Credential Type

None

Educational Level

1st year Community College or equivalent

Skill Level

Quality Assurance Organization