All that Glitters is not Gold – A Discussion on the Stark Differences in “cGMP” Plasmid Manufacturing, Quality, and Regulations, Upcoming Webinar Hosted by Xtalks


Register for the webinar and be armed with critical information needed for your next plasmid DNA outsourcing decision.

During this webinar, an expert panel will discuss how and why plasmid DNA manufactured under cGMP compliance helps mitigate downstream risks in the production of gene and cell therapies, and DNA and RNA vaccines for clinical trials, and commercialization. The US FDA and regulators globally are encouraging sponsors to use the highest quality plasmids possible for the manufacturing of viral vectors, or non-viral delivery systems. The regulatory guidelines are likely to become stricter as more products are approved.

The panel will then talk about the design approach Akron Biotech has taken to build a new plasmid DNA manufacturing facility to help alleviate some of the delays faced by gene and cell therapy sponsors in their preclinical and clinical programs. The discussion will highlight the importance of the quality incorporated from early process development to a validated commercial production process. The panel will also explain how the infrastructure, processes, know-how and quality systems help in the manufacturing of robust products and minimize batch-to-batch variability. Participants will be able to ask questions about specific areas of interest to them.

Register for the webinar and be armed with critical information needed for your next plasmid DNA outsourcing decision.

Join Katarina Stenklo, Enterprise Solutions Commercial Activation Leader, Cytiva; Tony Khoury, Executive Vice President, Project Farma; John P. Coyle, VP, Quality and Regulatory Affairs, Akron Biotech; and Sebastian Almeida, Director of Manufacturing and CMC, Biologics, Akron Biotech, in a live webinar on Thursday, July 29, 2021 at 1pm EDT.

For more information, or to register for this event, visit All that Glitters is not Gold – A Discussion on the Stark Differences in “cGMP” Plasmid Manufacturing, Quality, and Regulations.

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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