This Addendum signals the release of the design and dataset from the performance testing of the NIIMBL BioPhorum buffer stock blending (BSB) system. It is being made available as ‘open source’, which the team hopes will encourage industry adoption of the BSB System. The paper provides the team’s evaluation of the testing outcomes. It also contains information relating to the methods and approach, and the lessons learned so that others can develop and improve this technology by understanding its benefits and applications.
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NIIMBL Roadmaps: 1. Vaccines: 2. Antibody-Drug Conjugates (ADC) and Bi-specific Antibodies: 3. Gene Therapies
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) collaborated with BioPhorum to create and publish three technology roadmaps covering Vaccines, Gene Therapy and Antibody-Drug Conjugates/ Bispecific antibodies. Developed using the highly successful roadmapping process that led to the first edition of the BioPhorum Biomanufacturing Technology Roadmap. These documents compliment the original Technology Roadmap and detail the manufacturing challenges, technology needs and areas of opportunity in each of the three product categories with additional focus on US regulatory and workforce challenges.