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CMC Forum January 2018: Scientific Program
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To view the final scientific program for Methods on the Move, click here

To view the final scientific program for Production Cell Line Development, click here

 

 


 

Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry

Business and regulatory drivers have led to increased activity of analytical and biological method transfers, in the biopharmaceutical industry. Method transfer may occur between labs at the same company site, between sites of a company, or between companies. This increased activity in method transfers is occurring in the absence of clear regulator expectations and comes at a time of increasing scrutiny from both regulators and industry in defining what is needed for successful transfers. Questions range from whether a formal transfer is required for moving QC operations to a new building at the same site to technical requirements and submission strategy for transfer of complex analytical methods between companies. During this forum regulators and industry experts will discuss issues and successes they are observing with method transfers, approaches and regulatory strategies for submitting transfers to regulatory agencies.

 

Production Cell Line Development and Control of Product Consistency during Cell Cultivation โ€“ Myths, Risks and Best Practices

As the biotechnology industry continues to mature so has the fundamental understanding of the cell culture-based processes that are leveraged to manufacture biopharmaceutical products. Furthermore, new technologies are emerging that can provide additional insight through the characterization of these processes, specifically with respect to the cell substrate and cell culture process. This Forum will discuss, in the context of current understanding, considerations for the development of production cell lines including the choice of expression system, the characterization of cell populations and potential approaches to improve cell lines through host engineering. Additionally, approaches to ensuring appropriate control of product quality throughout the cell culture process will be discussed including advancements in analytical control strategies. Overarching objectives will be in defining the myths and risks to cell line development and product quality associated with cell cultivation, including current best practices. Case studies will be used to illustrate the scientific and regulatory challenges and the approaches that help ensure regulatory expectations are met when assessing and assuring the appropriateness of cell lines used for production of biotechnology products during development and commercialization.

 

 


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