TRM Projects Technology Roadmapping: making it happen 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 DeliverableAvailable 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. Reduces footprint for Cell Harvest facility Reduce pressure on biomanufacturing utilities needs and waste management Increase Robustness/Performance/Ease of Use. Reduction of containment risk. Q1 2019 Buffer Preparation (6)Development of specifications for buffer preparation systems that enable: Reduction in buffer prep footprint Reduction in buffer labor Reduction in buffer costs Reduction in buffer preparation time Buffer is not a facility capacity bottleneck Minimal facility footprint <50% of process footprint Enable inline testing & release of buffers 50% reduction in number of buffers 50% reduction in volume of buffer per kg product Reduce buffer labour by 90% Buffer capital- operating costs reduced by 75% 2019 Continuous Downstream Processing (20) 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 Recommend industry strategy for implementation of continuous downstream processing Identify collaboration opportunities to move industry forwards at pace Identify business drivers for continuous processing 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: Reduction in cost of supply Reduction in cost of non-quality Reduction in time to release product from 4-6 weeks to 1-2 days Q2 2019 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 Speed up product release from 35 days to ≤ 2 days for virus testing & 14 days to to ≤ 2 days for sterility testing Free up working capital for biomanufacturer Reduction in amount of at-risk product if an excursion is identified Q1 2019 Modular and Mobile Standard Facility Design (15)Define user requirements and standard facility options to rapidly respond to biologics manufacturing production needs (less than 1 year response time). Speed of deployment, including design and build Speed of product launch Flexibility to use the site for multi-purposes and multi-products Cloning and copying of the site also for in-country/for country installations Capacity flexing or scaling without interruption of existing processes Mobility, if needed to bring capacity to the location of demand 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 Reduce time to assemble data (80% to 10%), increase time to process data (20% to 90%) Direct benefits is reduction in time for investigations by having contextualized data available. Indirect benefits by providing contextualized data to other work streams (like MVA, PAT, CPV, etc.) enabling them to implement solutions quicker with less costs. Q4 2019 Robotics (13/14) White Paper & Journal Article, including End User Survey Proven performance and OPEX reduction cases. Reduced health and safety risks to personnel More efficient use of personnel Greater throughput / productivity Reduction in errors Improve quality of operations Q1 2019 Plug & Play (21) Proof of concept, connect skid control system to PCS with soft simulation of skid equipment. Definition of 3 data models – Bioreactor, Chromatography, Normal Flow Filtration Speed - faster build times and reconfiguration times, delay decision to build Cost - eliminate development costs for custom interfaces Quality - reduced verification and variability. Flexibility - ability to easily switch unit op technology to best in class Q3 2019 Knowledge Management Knowledge Management (2/16) Develop framework for biopharm industry describing standardised approach to managing product and process knowledge across lifecycle. Higher process capability (RFT, lower OOS) More informed and faster decision making Enablement of ICHQ8-12 Process improvements introduced faster. Better understanding of correlations between cmas, cpps and cqas leading to improved process control Improved speed and quality More knowledge is re-used Greater ability to measure the performance of knowledge flow. Including modelled productivity improvement, e.g. FTEs per filing or MPV on a product, PPQ success rate? Q2 2019 Submit a Comment Cancel reply Your e-mail address will not be published. Required fields are marked *Comment Name * Email * Website Save my name, e-mail, and website in this browser for the next time I comment. This site uses Akismet to reduce spam. Learn how your comment data is processed.