Process Development: Getting from Phase I to III, Upcoming Webinar Hosted by Xtalks
In this webinar, the featured speaker will discuss the essential elements of a process development program to support developing a robust process in line with the product progression in the clinic. The discussion will offer insight into how to take a holistic approach to developing processes with an eye to future development. The presenter will also discuss how to manage risk, make compromises and trade-offs to expedite your process development program and how to develop robust processes while managing resources in the process development.
TORONTO, June 24, 2021 /PRNewswire-PRWeb/ -- Successful biopharmaceutical Chemistry, Manufacturing and Controls (CMC) development requires a clear understanding of the requirements and expectations to support taking a product into the clinic. Even after the product has entered the clinic the CMC development journey continues.
In moving through the CMC development cycle, it is important to prospectively identify where there may be knowledge gaps and to create studies to address them. Risk management is used to build robustness and contingencies into the process development plan. It is also essential to look at where compromises and trade-offs are in the process development approach.
Register for this webinar to hear a discussion about how to structure a biopharmaceutical process development program to build supporting data as the product progresses in the clinic. It will touch upon gaining understanding of the key quality attributes and critical process parameters as part of developing the process. This includes methodology that takes a holistic approach to process development. The discussion will also cover the importance of generating product and process intermediate stability data as part of the CMC package.
Additionally, the discussion will touch upon how developing process robustness while also managing resources is a key success factor. To explore this concept, there will be an overview of how to define the "good enough" areas in process development, where 80 percent may be good enough and where it may not. It will also include where and when it makes sense to leverage platform data in process development.
Join Louise Duffy, SVP, Scientific Project Leaders, Abzena, for the live webinar on Wednesday, July 14, 2021 at 10am EDT (3pm BST/UK).
For more information, or to register for this event, visit Process Development: Getting from Phase I to III.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
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Ayesha Rashid, Xtalks, +1 (416) 977-6555 x 272, [email protected]
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