Modeling

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Targeting ‘right first time’ with the new In-silico Strategies Workstream

In-silico modeling is an exciting, new area for many biomanufacturers as it creates the opportunity to reduce wasted experiments, lower costs and accelerate development. However, there are many challenges ahead before it is used effectively and consistently, including different methodologies being applied and the need for data quality. BioPhorum Development Group’s sponsors highlighted that in-silico modeling is an industry hot topic and so the...

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Lyophilization: An industry perspective on the application of modeling to lyophilization process scale up and transfer

While freeze-drying modeling is well established and documented, the extent of its application to routine operations, including development and manufacture, has not yet been fully realized. A survey, conducted by BioPhorum, revealed that only a few companies use modeling for scale up and transfer. For the last year, the collaboration has been combining individual company efforts with the aim of harmonizing best practices and helping to define minimum regulatory standards. This paper outlines different applications of modeling to freeze-drying of biopharmaceutical products at commercial scale. It also signals the intent of the BioPhorum to champion a wider adoption, and realize the full potential of modeling across the industry to standardize lyophilization practices, accelerate technology transfers and optimize operational performance

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Lyophilization: Freeze-dry cycle modeling education pack

While freeze-drying modeling is well established and documented, the extent of its application to routine operations, including development and manufacture, has not yet been fully realized. A survey, conducted by the BioPhorum collaboration of major pharmaceutical companies, revealed that only a few companies use modeling for scale up and transfer. To address this the Fill Finish collaboration has been combining individual company efforts with the aim of harmonizing best practices and helping to define minimum regulatory standards.  As a result of this during 2016 the Lyophilization team agreed an education package that details how an operation can develop, validate and utilize a computer model for a commercial scale lyophilisation system for parenteral drugs.  This pack was presented to the FDA during Sept 2016.  

THIS PACK IS ONLY AVAILABLE TO MEMBERS OF BIOPHORUM FILL FINISH. 

If your company are members of BioPhorum Fill Finish, one of you colleagues will be able to give you access.  If your company are not members of BioPhorum Fill Finish but you are interested please contact us to understand more

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