The biopharmaceutical industry has evolved in the last few decades and the rapid demand for antibody (Mab) product is narrowing the overall lifetime from discovery to market. This has led to the implementation of platform processing for rapid technical transfer and commercialization. Technical transfer in the recent years often included transferring to a CMO or partnership which is a complex process involving different levels of experience and expertise. A technical transfer includes transferring the complex technical process, CMC, regulatory, analytical methods, validations, supply chain and facility fit. In addition, the fast track has added risk associated as it involves the manufacture of clinical drug substance lots, and late stage development in advance of process validation. Risks were minimized from the learnings and several items were identified and incorporated from one process to the other.During the Mab downstream process technical transfer and scaling up to seventy five fold led to several process changes and involved redesinging steps to accomdate and adapt to an exisiting facility. Few examples are (1) in one process this resulted in the installation of a filter train to accomdate the large filtration area requirement. This led to additional studies like product compatiblitly assement, validation of the extractables and leachables. (2) Unknown hold ups and piping modification led to redefining a key process parameter for product collection (pooling criteria). For a chromatography step the pooling of the product pool by volume collection was reevaluated and replaced with a complex UV trigger. This change was based on theoretical calculation and endangered the first few batches. (3)The pH and conductivity ranges for a critical process buffer needed to be widened due to operational differences.

Technical Transfer leading to redesigning several key and critical process parameters in downstream Mab process

247th National Meeting (2014)

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