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

 
  July 16, 2021  
     
 
Xtalks, Online
2021-07-29


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 in clinical trials and during commercialization. The US FDA and other global regulators are encouraging sponsors to use the highest quality plasmids possible for the manufacturing of viral vectors, or non-viral delivery systems. As more such products are approved over time, the regulatory guidelines are likely to become stricter.

The panel will then talk about the design approach Akron Biotech has taken to build a new state-of-the-art 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 a robust product 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.

 
 
Organized by: Xtalks
Invited Speakers:

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

Sebastian Almeida, Director of Manufacturing and CMC, Biologics, Akron Biotech

 

 

 
Deadline for Abstracts: -
 
Registration: Register at Xtalks.
E-mail: jozeph@xtalks.com
 
 
   
 
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