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19 May 2021Ended

Accelerating Biologics Drug Development with an Expanding Analytical Toolkit

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upto 100
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Based on previous editions

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May 2021

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Development of innovative biologics therapy is challenging due to molecular complexity, time intensive processes, and high failure rate in process .. Read more development and in the clinic, making the process long and expensive. Deeper knowledge of the physiochemical properties biologics can aid in decision-making early in development and help inform improvements during the transition from discovery to the biologics license application (BLA). This webinar will detail improvements we have implemented during our development process and focus on the benefits of an appropriate analytical toolkit to fit the needs of the biologic and process being developed. Our approach gains the most benefit by using this analytical toolkit during the early process development stages. We will highlight a few key examples where monitoring proves to be most impactful in the process, for example in cell line development or downstream process development. Powerful analytics can decrease timelines and enhance process robustness, but also provide a deeper understanding of the impact of process steps on product quality. By the end of the webinar, we will have demonstrated that selecting key product attributes and monitoring those attributes through process development can have a major impact on the product quality.

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