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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
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%

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

  • 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
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

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One Pancras Square

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