The BioPhorum Technology Strategy portfolio focuses on three priority areas:
- Ultimate facility design (multi-modal and towards ‘lights out’ manufacture)
- Autonomous and advanced process control
- Knowledge management for future manufacturing.
Building on the longer-term strategic initiatives established in BioPhorum Technology Roadmapping, the portfolio of activitiesoffers members realizable benefits spanning a timeline from ten years to one year depending on whether the focus of activity is roadmapping, technology acceleration or proof of concept.
BioPhorum Technology Strategy seeks to grow and strengthen roadmapping activities aligned with industry mega trends, progressing with part two of the digital technology roadmap and commencing robotics and automation for lights out manufacture. We will continue to identify areas for proofs of concept to demonstrate technical and business feasibility of technological solutions and publish best practice guidance for translation and adoption of such technologies. Technology adoption will be accelerated through access to a suite of resources such as podcasts, white papers, blueprints, adoption frameworks, industry consensus standards and digital assets
Proofs of concept
BioPhorum Technology Strategy is developing and implementing proofs-of-concept, which demonstrate in a tangible and practical way the technical possibilities and business feasibility.
Buffer stock blending system
A cross-functional team, assembled as part of the BioPhorum Technology Roadmapping initiative, has designed and built a full-scale cGMP buffer stock blending system in collaboration with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
The design documentation and performance data for the buffer stock blending (BSB) system has been made available open-source under a freedom to operate agreement, and can be downloaded below, to enable manufacturers to deliver buffer on-demand on a commercial scale at significant cost savings in labour and cost per litre compared to traditional buffer preparation methods.
Aggregates RT-MALS Proof of Concept
Eighteen BioPhorum Technology Strategy member companies (eleven biomanufacturers, seven supply partners) are collaborating on a proof of concept for real-time monitoring of aggregate content in a chromatographic purification for monoclonal antibodies, specifically the cation exchange bind and elute polishing step, using real-time multi-angle light-scattering (RT-MALS) technology.
The practical work is ongoing. This activity has built up empirical knowledge of the relationship between the quantities measured in real time and the aggregate content, and the team is now using the information to build a model needed to monitor aggregate content in real time.
Automated Bioreactor Proof of Concept
A team of 25 organizations has scoped a proof of concept for a fully automated, perfusion, single-use bioreactor demonstrating automated control of selected attributes, automation of seed train inoculation and harvest, and MVDA (multi-variant data analysis) orthogonal verification in combination with multiple integrated PAT tools for real-time process monitoring/control and automation of control actions.
The use of integrated process analytical technology (PAT) tools for dynamic and autonomous control is lagging, especially in terms of widespread implementation. Industry guidance on how to implement and validate these tools will be a key deliverable for this work which when implemented will result in the realization of cost savings through increased automation and reduced batch deviations and lead times, improved consistency of product quality and shortening of technology transfer timelines.