A year after the publication of the First Edition Biomanufacturing Technology Roadmap, this process is not only enabling biomanufacturers in the Phorum to share dynamically technology strategies with each other, but also share these with supply partners, academia and regional agencies enabling all stakeholder groups to align their technology development efforts to the needs and challenges of the entire industry.
Moreover, the strategic discussions among members have enabled Technology Roadmapping to mobilize teams to work towards outcomes establishing a portfolio of high-impact projects that will accelerate technology development and adoption.
Focusing on the most impactful opportunities where industry collaboration is required, the Phorum has launched a suite of projects, in the six key areas of process technology, in-line monitoring and real-time release, modular and mobile, fully automated facility, knowledge management and supply partnership management.
A table describing the implementation projects is shown. These projects are already moving with great momentum and delivering key milestones. In the plug and play project, for example, Supply Partner members are now aligned to deliver a physical prototype.
Open industry collaboration has been a critical factor in making these projects possible. As each project delivers on its goals, so it will deliver measurable industry progress to the benefit of individual Phorum members and, eventually, to the entire biomanufacturing industry.
TRM Value Tracker
A summary of the implementation portfolio deliverables and benefits
|Enabling technologies and capabilities||Implementation project title and number||Deliverable||Available Company Benefit||When|
|Process Technology||Harvest Clarification (5)||A batch harvest solution to rapidly process high density cell culture in a single use, flexible facility using limited floor space in a non classified environment.||Q1 2019|
|Buffer Preparation (6)||Development of specifications for buffer preparation systems that enable:||2019|
|Continuous Downstream Processing|
|White paper to accelerate technology adoption. Consists of a comprehensive gap analysis of process, automation and inline monitoring to collaboratively address concerns of industry with regulatory bodies||Q1 2019|
|In Line Monitoring and Real-time Release||Rapid release testing through inline monitoring (1/7)||White paper with URSs to guide the development of new in-line, at-line and on-line technologies, focused on highest impact CQAs and IPCs.|
Inform industry of which CQA’s & IPC’s to be targeted for transition to in-line, on-line or at-line monitoring which will lead to:
|Rapid methods for adventitious detection & sterility assurance (8)||White paper containing URS for development of new rapid methods and plans to overcome barriers of adoption. This technology will have a huge impact on drug substance inventories and working capital||Q1 2019
|Modular and Mobile||Standard Facility Design|
|Define user requirements and standard facility options to rapidly respond to biologics manufacturing production needs (less than 1 year response time). ||Q2 2019
|Fully Automated Facility||Big data to smart data (9/10)||Industry standard taxonomy / indexing for data sources that supply data for manufacturing. Architecture for solution for adding context to data sources that can’t add in context when data created||Q4 2019
|Robotics (13/14)||Q1 2019
|Plug & Play (21)||Q3 2019
|Knowledge Management||Knowledge Management (2/16)||Develop framework for biopharm industry describing standardised approach to managing product and process knowledge across lifecycle.||Q2 2019