URS

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In-line monitoring / real-time release testing in biopharmaceutical processes – prioritization and cost benefit analysis

The goals of an effective in-line monitoring and real time release testing (ILM-RTRT) and predictive modelling strategy are to leverage enhanced process understanding, risk mitigation and process control improvement to reduce the reliance on end product testing while improving early detection of catastrophic failure. Additionally, ILM and RTRT will enable cost reductions, product and process consistency and speed to market while enabling continuous improvement. But of the multitude of critical quality attributes and critical process parameters, which should be prioritized first for transition from off-line monitoring to in-line/on-line/at-line monitoring?

This paper not only answers the prioritization question but also provides supporting quantitative business case information along with technology-agnostic User Requirement Specifications (URS) for each of the attributes to serve as a guide for technology suppliers in the development of systems that will meet industry standards for ILM and RTRT.

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Harvest clarification: User requirement specification (URS)

Cell separation technologies can be challenging. They are not robust or cost-effective enough to handle ultra-high density, cell culture batch harvests, especially in single-use processing. This is an issue with an anticipation that needs are increasing to removal of cells from cultures that are up to 30–50% solids as measured by packed cell volume. To remedy this situation, new technologies must be created as manufacturing will increasingly demand larger facilities and more classified spaces, which will both impact on costs. Without change, harvest clarification will become a limiting step. To address this the BioPhorum Harvest Clarification team a group of eight biomanufacturers and four supplier companies has created a user requirements specification (URS) for a harvest clarification solution that will handle ultra-high density mammalian cell cultures. The URS explains biomanufacturers’ business needs to suppliers to help drive the innovation needed to stop harvest clarification from becoming a bottleneck. The business drivers of cost, speed, quality and flexibility will all be improved with the successful implementation of new solutions driven by the specification. It will also increase performance and ease of use, while reducing containment risk, the footprint of cell harvest facilities and the pressure on utility needs and waste management.

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URS for small flexible filler technology

As the product in company pipelines increase in number and reduce in expected patient numbers there is a need to move from large batch, high-speed lines, to agile units that can rapidly switch between products. These changes are leading to innovation and creativity from equipment suppliers, but in addition customers need more standardization and fewer proprietary systems to aid with interchangeability, reliability and unit cost reduction. To make this happen in good order users need to ask for similar capabilities, using the same language to create necessary pull to influence equipment suppliers. This URS establishes an industry benchmark of flexible filling needs and serves to streamline the acquisition and approval of new equipment by pharma company leadership. It will enable the industry to bring products to patients faster and reduced costs through use of standard components and processes. Ultimately, enabling organizations to develop small-batch capabilities in preparation for the future of personalized medicines.

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