Lyophilization


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A best practice approach for lyophilizer leak rate testing

The vacuum integrity of freeze dryers is critical for process control and maintaining confidence in sterility assurance – it is therefore key for manufacturing sterile pharmaceutical products. Although discussions on this topic have been widely published, there is no universally recognized standard, empirical standard, or scientific rationale on which to base acceptable limits on leak rates. Historically, the calculations were based on a single...

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Lyophilizer leak rate testing – An industry survey and best practice recommendation

The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have been published, there is no industry standard established that is based on empirical data or that has a justifiable scientific rationale. This paper published in the Journal of Pharmaceutical Sciences provides a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry. Using this information the BioPhorum team recommend a best practice for the lyophilizer leak rate test.

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How to perform aseptic process simulation for lyophilized products

Proposed 2020 revisions to EU Annex 1 around aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on the need for clear best practices for the process simulation of the lyophilization unit operation.   To address these expectations, BioPhorum has written an article called A better approach to aseptic process simulation for lyophilized products, which presents a risk-based, holistic best...

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Application of first principles primary drying model to lyophilization process design and transfer: case studies from the industry

Lyophilization modeling is well documented in academic circles but has not yet been widely adopted by pharmaceutical manufacturing companies. To facilitate wider adoption and implementation, an accessible Excel–based tool is provided, presenting several fresh examples as a practical introduction to the process of modeling the primary drying phase. Case studies are presented of the tool’s application during process development and scale up which highlight business benefits that have been realized by using the model. Written by members of the BioPhorum’s Lyophilization Workstream, this paper published in the Journal of Pharmaceutical Sciences is intended to serve as a pathway to not only share the collective knowledge on the topic but also accelerate its adoption in the industry.

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How to save time and money using lyophilization modeling

An iterative design of experiments (DOE) approach has traditionally been used to perform lyophilization cycle development at small and manufacturing scales. Unfortunately, this is resource-intensive and needs large amounts of material that can make it prohibitively expensive, particularly on a commercial scale. This often prevents the use of screening experiments required to identify the optimal cycle parameters with large volumes. An...

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Lyophyilization: commercial scaling modelling

This paper outlines different applications of modeling to freeze-drying of biopharmaceutical products at commercial scale. It also signals the intent of the BioPhorum collaboration 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. An Industry Perspective on the Application of Modelling to...

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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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