Technology Roadmapping

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White paper addendum to the NIIMBL-BioPhorum buffer stock blending system – a more advanced concept for buffer manufacturing

White paper addendum to the NIIMBL-BioPhorum buffer stock blending system – a more advanced concept for buffer manufacturing

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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Digital Technology Roadmap

Digital Technology Roadmap

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.

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Automation and the road to lights-out manufacture in biopharmaceuticals

Automation and the road to lights-out manufacture in biopharmaceuticals

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...

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Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation

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.

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Operational vision: Adoption of in-line monitoring and real-time release

Operational vision: Adoption of in-line monitoring and real-time release

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.

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Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design

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.

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