Elements for Smooth Technology Transfers of Biologics Manufacturing Processes, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speaker will discuss the essential elements for the successful technology transfer of biologics manufacturing processes and an effective communication plan for smooth interactions. Attendees will learn the information necessary to define a biologics manufacturing process and assist in its further development, risk management and criteria to determine whether a transfer has been successful.

Xtalks Life Science Webinars

Good communication plans facilitate effective information exchange and enable timely discussion of progress/questions/changes/hurdles that arise during collaborative manufacturing campaigns.

Effective communication, complete and accurate information transfer, risk management, and clear success criteria are essential elements for smooth and effective technology transfers of biologics manufacturing processes. This is true whether the technology transfer is only a protein sequence or involves the transfer of fully developed processes and testing methods. Good communication plans facilitate effective information exchange and enable timely discussion of progress/questions/changes/hurdles that arise during collaborative manufacturing campaigns. They are mutually developed by all parties and identify the individuals involved, along with their contact information, define roles and responsibilities, establish key deliverables and delivery dates, set meeting schedules, and establish guides for ad hoc communication channels.

The information is commonly included in a series of reports, including a product description, process description(s), process development report(s), analytical methods descriptions, analytical methods qualification reports, analytical methods validation reports, formulation development reports, and stability reports. Review of the available data allows the participating parties to identify knowledge gaps and to create plans to address them.

Risk management builds robustness and contingencies into the technology transfer process. Identification of potential pitfalls, their probabilities, and the severity of the resultant consequences informs the technology transfer team’s work plans and the proactive scheduling of contingency activities. Finally, establishing clear criteria for a successful transfer, along with the mechanisms to demonstrate their achievement, complete the technology transfer process. This usually includes performance of the transferred processes and analytical methods at one or more scales in a way that meets the agreed criteria. Diligent attention to these essential elements establishes a strong foundation for a successful technology transfer and future collaboration activities.

Join Louise Duffy, Ph.D. SVP & Head of Scientific Project Leaders at Abzena in a live webinar on Wednesday, October 21, 2020 at 11am EDT (4pm BST/UK).

For more information or to register for this event, visit Elements for Smooth Technology Transfers of Biologics Manufacturing Processes.

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.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Sydney Perelmutter
Xtalks
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