A knowledgeable and active community exploring questions, problems and challenges for lyophilization from both operations and development. The team is currently working on the design of a reliable, consistent approach for the development of robustness studies to support cycle deviations during manufacturing.
Lack of clear rule or rationale on what a robustness study should look like
Cycles are designed within narrow range of process parameters; the impact of wide process parameters’ design space on product quality is not widely understood or accounted for. Coupled with a lack of best practices/case studies and regulatory guidance on expectations, the rationale on what a robustness study should entail is not clear and consistent across the industry.
An unreliable process causes quality assurance issues and an increase in manufacturing investigations, increased documentation and therefore increased time to completing the drug product
Development of a reliable, robust lyopholization process
Development of robustness studies to support cycle deviations during manufacturing, using design space to guide the development of a robust lyophilization process. The aim is to reduce of batch losses and rejections, investigations due to minor deviations and the associated investigation documentation.
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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