Phorum

Drug Substance

Delivering globally on in-line monitoring and real-time release

BioPhorum is increasing its focus on delivering against strategic goals of member companies as outlined in the BioPhorum Biomanufacturing Technology Roadmap. The first step in achieving this is to form a team with a cross-Phorum focus to implement these technologies – the ILM/RTR Adoption team. The team will look at the ongoing work and opportunities to collaborate on environmental, organizational and technical factors that can be most readily addressed at industry level.

The BioPhorum Biomanufacturing Technology Roadmap (The Roadmap) set a broad vision for the future of biomanufacturing to catalyze industry action. It identified the market trends that are exerting massive pressure on the industry to evolve and deliver a step change in performance and cost reduction.

In-line monitoring and real-time release

The Roadmap highlighted that in-line monitoring and real-time release (ILM/RTR) has a crucial contribution to make in this change.

Currently across our industry 60-70% of process testing and environmental monitoring of bulk drug substance and drug product is performed either at-line or off-line; requiring significant amounts of non-value adding work, sample collection, labeling, transport to the QC laboratory, sample receipt and logging, sample testing and communication of results. The entire process is inefficient.

Implementing in-line, real-time monitoring for bioprocesses presents both a unique opportunity and bewildering challenge given the complexity of bioprocesses, the variability of raw materials, and living organisms, plus the need to do it in single-use equipment and in facilities shifting from batch to continuous processing.

A successful implementation in a fully automated facility will need robust, reliable, low-cost and easy-to-maintain in-line probes.

Next steps

The Roadmap has gained significant credibility in the industry and has initiated a number of successful technology development projects. As a result, it is increasingly being seen by leaders as an indispensable vehicle for making the future happen.  After consulting all of the BioPhorum Drug Substance member companies, and confirming this with a range of other sponsors ILM/RTR was chosen as the first cross- Phorum initiative with a mandate to make adoption into day to day operations a reality.

ILM/RTR has the following goals:

  • Speed: a reduction in the time to release a product from 4–6 weeks to 1–2 days
  • Cost: a 90% reduction in inventory quantity
  • Quality: a reduction in the cost of non-quality to 2% of total operational costs.

The team has already identified the attributes that are the most critical in realizing these goals to biomanufacturers, key suppliers and academic researchers.

The ILM/RTR Adoption team is now being recruited and around 15 companies are already providing resources for the project.

Dave Connolly, Head of Manufacturing Science & Technology at Takeda commented, “Working with BioPhorum on this topic provides an exciting opportunity to deliver on the industry’s In-line Monitoring and Real-time Release ambitions. Working in concert with key stakeholders across other leading biopharma companies ensures that we maximize the return on our individual efforts and crucially enables us to make real change at the industry level.”

There is a huge amount of work ahead to achieve the vision set out in the Roadmap and meet the challenges of delivering successful ILM/RTR. But with your help, we can achieve great things.

For more information about the ILM/RTR project, contact Derek Willison-Parry through info@biophorum.com.

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

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