This workstream is creating best practices for the changeover and cleaning of multi-product facilities by developing technological improvements and standard processes to increase productivity, maintain compliance, and conserve resources.
Process revalidation reduces available manufacturing time
The team has been addressing hot topics relating to cleaning practices to align the industry and provide justification and supporting rationale for when cleaning validation is/is not required.
Increasing flexibility in the re-use of Protein A resin across multiple products within clinical manufacturing
Dedication of protein A resin to a single product for clinical manufacture creates high material costs, increased turnaround time between products, and logistical problems with resin storage and testing. This is due to the frequency and/or volume of clinical supply being lower compared to a commercial process.
In collaboration with the University of Limerick, the team is developing a standard risk assessment to identify potential carryover risk and supporting data/case studies to enable greater flexibility in the use of this material.
Multi-Product Facility deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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