Lyophilisation workstream plan 3 good practice guides
The Fill-Finish Lyophilisation (Lyo) workstream plan to write publications which will facilitate adoption of good practices. Following constructive discussions with Purdue University’s LyoHub consortium, the team will be working on the following three publications in 2017.
Their primary publication in 2017 will be an industry perspective on modelling. Noting the under-utilization of modelling at the commercial scale in the industry despite a substantial literature on the topic, the team want to support adoption by addressing some of the practical challenges. They will describe fully the advantages and value of modelling for both new products and legacy products. Topics in the paper will include: how to use scale-up data to go from lab to commercial; how use to model to optimize cycles (including building the design space); and how to apply modelling to analyse deviations e.g. how to estimate impact and support reject/not reject decisions when lacking product temperature data. Available data on vital input parameters will be added to the paper. The team will also recommend minimum regulatory standards with a view that our recommendation become adopted by the agencies.
Two further publications will be industry commentaries on best recommendations from Purdue University’s LyoHub consortium. The consortium, including contributions from workstream representatives Serguei Tchessalov and Ted Tharpe, have developed best practice guidance on shelf mapping requirements; equipment limit testing; condenser performance metrics; and the allowable leak rate in chambers.
In another publication, Professor Alina Alexeenko and Dr Liz Topp, describe best practice recommendations for product temperature in vials and pressure measurements. The workstream will write separate commentaries of these two sets of recommendations. Describing with survey data how the recommendations have been interpreted, used in practice and close any gaps in the details of recommendations which will help adoption on the ground.