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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The pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.
This paper outlines the foundational element that chart the course for pharmaceutical manufacturers who decide to take this journey and provides a vision of what that destination could look like in 10 years’ time. It outlines the current state of the industry, key challenges and barriers to adoption, and hints at the value that taking this journey will bring to patients, organizations and industry. This paper (which forms Part 1 of the Digital Technology Roadmap) looks at the problem statement and the work that has gone before.
Jul 2022 | Technology Roadmapping
Over the last year, BioPhorum’s Technology Roadmapping (TRM) Robotics group has developed a high-level roadmap to lights-out manufacture, with special consideration given to the contributors holding back the lights-out manufacture of biopharmaceuticals. The roadmap lays out the associated steps from lights-out automation of packaging and material transport to achieving a full lights-out cell therapy facility over the next decade. In our goal of...
Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation
This paper addresses the need for a systematic and best practice approach to the evaluation, validation and implementation of these methods related to adventitious agents testing to support the adoption of alternative adventitious agent testing (AAT) methods. A nine-step framework and common language are described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs and alternative AATs.
Jun 2022 | Cell & Gene Therapy, COVID 19, Deliverable, Deliverables Report, Development Group, Drug Substance, Fill Finish, Information Technology, Inline Monitoring and Realtime Release, Publication, Supply Partner, Technology Roadmapping
Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.
Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design
This paper uses a standardized, modular design and construction approach the benefits of a modular design approach to a multi-product viral vector (VV) facility at late-clinical/early-commercial scale, showing how significant speed benefits can be gained at each stage of facility design, procurement, construction, qualification and operation.
NIIMBL-BioPhorum Buffer stock blending system: vision, collaboration, design and outcome On behalf of the NIIMBL-BioPhorum BSB System Team Presented by: Jeff Johnson – Biotech Design, LLC Biotechdesignllc.com BPI Europe – 18 May 2022
Document designed to support the design of a checklist for technology readiness in an end-user company technology implementation program.