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The Northeast Biomanufacturing Center and Collaborative (NBC2) has created this laboratory manual that can be  downloaded as a pdf. The Biomanufacturing Laboratory Manual is 390 pages in length.  It is divided into ten sections that include:

  • Metrology
  • Validation
  • EH & S (Environmental Health & Safety)
  • Quality Assurance (GMP Popcorn Exercise)
  • QC Microbiology
  • Upstream Processing: E. coli - GFP
  • Upstream Processing: CHO Cell - tPA
  • Upstream Processing: Pichia pastoris - HSA
  • Downstream Processing: tPA and HSA
  • QC Biochemistry

Each section contains multiple standard operating procedures, a batch record, and a competencies list.  An appendix is also included at the end of the laboratory manual, which includes short protocols for both human tissue plasminogen activator (tPA) production in a spinner flask and human serum albumin production in a shake flask. 

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