The Northeast Biomanufacturing Center and Collaborative (NBC2) is a National Science Foundation Advanced Technology Education regional center that has been in existence since 2005. Several NSF-funded texts have been made available by NBC2. The following resources are not openly licensed, but are freely available. The descriptions below are from the NBC2 website or the indicated resource’s site.
- Introduction to Biomanufacturing This comprehensive textbook in biomanufacturing was written by industry subject matter experts. It contains 15 chapters is organized into five units: introduction to biomanufacturing, engineering, quality, production, and manufacture of a drug product. Request access to the affiliated Instructor’s Portal to gain access to PowerPoint presentations aligned with each textbook chapter, curriculum modules, a comprehensive biomanufacturing exam, and template Standard Operating Procedures (SOP’s).
- NBC2 Biomanufacturing Laboratory Manual The NBC2 Biomanufacturing Laboratory Manual is a companion piece to the Introduction to Biomanufacturing textbook. The lab manual is SOP-driven and follows the content order of the textbook. The lab manual guides students through hands-on laboratory activities, provides training on industry-grade equipment and introduces students to conducting experiments while following current Good Manufacturing Practices.
- Production of Monoclonal Antibodies Laboratory Manual This lab manual accompanies the aforementioned Introduction to Biomanufacturing textbook and contains flow charts, SOP’s, batch records, and user guides to direct students through anti-IL-8 monoclonal antibodies from CHO cells. It includes upstream processes, quality control, downstream processes, and equipment related to the production and purification of anti-IL-8 monoclonal antibodies.
- Escherichia coli – GFP Core Production Manual The E.coli-GFP Core Production System Manual contains Standard Operating Procedures for the batch culture of recombinant E.coli., as well as a complete batch record for the entire upstream process. In addition, a list of skills and knowledge required for an Upstream Process technician is included.
- CHO Cell – tPA Core Production Manual The CHO Cell tPA Core Production System Manual includes upstream processing (cell culture) Standard Operating Procedures (SOPs) with batch record, downstream processing (purification) SOPs with batch record, and quality control biochemistry SOPs, including SDS PAGE, tPA ELISA, and a tPA activity assay.
- Pichia pastoris – HSA Core Production Manual by Northeast Biomanufacturing Center & Collaborative (NBC2) The Pichia pastoris Core Production System Manual includes upstream processing Standard Operating Procedures (SOPs) and batch record for the process controlled fed batch fermentation of recombinant Pichia pastoris. Downstream processing SOPs include tangential flow filtration and affinity chromatography using the Biologic LP system. Quality control SOPs and a competencies list for downstream process technicians are also included.