Biomanufacturing Laboratory Manual

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.