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

Life Sciences, Clinical Trials, Pharma Manufacturing & Supply Chain, Preclinical,
  • Thursday, July 29, 2021 | 1pm EDT (12pm CDT / 10am PDT)
  • 60 min

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.

Speakers

Claudia Zylberberg, PhD, Founder and Chair, Akron Biotech

With over 30 years of experience in the regenerative medicine industry, Dr. Zylberberg has established herself as a leader in her field. Claudia’s passion for pushing the industry forward in the development and commercialization of safe novel therapies also led her to co-found the Standards Coordinating Body and serve as an active member of numerous industry boards and advisory committees.

Her experience in product development and manufacturing was instrumental in the development of key materials to accelerate the regenerative medicine industry. She holds numerous patents and developed several patent-pending platform technologies in cryopreservation, novel formulations, and others.

Claudia received her PhD from the University of Buenos Aires, where she studied Immunology, and conducted her doctoral research at the University of British Columbia.

Message Presenter
http://John%20P.%20Coyle,%20VP,%20Quality%20and%20Regulatory%20Affairs,%20Akron%20Biotech

John P. Coyle, VP, Quality and Regulatory Affairs, Akron Biotech

John is the Vice President of Quality and Regulatory Affairs for Akron Biotech. With over 30 years of pharmaceutical industry experience, John has experience across the entire life cycle of pharmaceutical products from R&D, pre-clinical testing and dossier submission, to manufacturing, testing and stability. John has worked at several major pharmaceutical companies including Allergan, GlaxoSmithKline, Teva, Proctor and Gamble and Catalent. He has extensive experience working with the FDA and a variety of global regulatory agencies. John has a degree in biology from the State University of NY at Old Westbury.

Message Presenter
http://Sebastian%20Almeida,%20Akron%20Biotech

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

Sebastian Almeida is Director of Manufacturing and CMC Biologics at Akron Biotech. Sebastian is responsible for cGMP compliant manufacturing and quality control for plasmids, recombinant interleukins, and growth factors. Sebastian has over 15 years of experience in the biopharmaceutical industry, specializing in R&D, manufacturing, regulatory affairs, and quality assurance. He spearheaded the development and large-scale manufacturing of over 18 biologics, including plasmids for gene therapy, recombinant monoclonal antibodies, human interleukins and growth hormone. Sebastian coordinated the successful construction of two pharmaceutical manufacturing plants, technology transfer, and the launch of recombinant protein production. Sebastian obtained his bachelor’s degree in Biology from the Centro de Altos Estudios en Ciencias Exactas in Argentina, and post-graduate education in Quality from the Buenos Aires Institute of Technology.

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http://Tony%20Khoury,%20Project%20Farma

Tony Khoury, Executive Vice President, Project Farma

Tony Khoury is an experienced industry leader in life sciences, specifically biologics and advanced therapies. As a member of the Project Farma leadership team, Tony has spearheaded the firm’s growth in biologics and, most recently, next-generation medicines. Tony has extensive experience with small and large molecules, including biologics, biosimilars, and cell and gene therapies. He has worked with small and large life science organizations including startups, academic centers, financial institutions and CMOs/CROs. He has led global programs greater than $350+ million in the following disciplines: project management, turnkey facility builds, automation, validation, engineering and serialization track and trace. Recently, Tony has pioneered the industrialization of advanced therapies including two FDA-approved cell and gene therapies and has led the creation of Project Farma’s Advanced Therapy Manufacturing Playbook which has helped develop the largest cell and gene therapy manufacturing footprint in the world.

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http://Katarina%20Stenklo,%20Cytiva

Katarina Stenklo, Enterprise Solutions Commercial Activation Leader, Cytiva

Katarina Stenklo is an experienced biopharma professional with over 19 years of industry experience. She works for Cytiva as Commercial Activation leader for the Enterprise Solutions business unit and primarily focuses on developing, launching, and optimizing the FlexFactory and KUBio portfolio of products. Katarina knows how important it is to have a holistic view of the manufacture of biomolecules. She has extensive expertise in developing end-to-end manufacturing solutions that includes process workflows, process equipment, automation, consumables, and facilities. Her focus over the last few years has been developing and designing solutions for the manufacture of viral vectors, plasmids, and mRNA therapies.

Katarina holds a licentiate degree in biochemistry. She spent 14 years in Cytiva R&D managing projects and people and developed various products and processes.

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Who Should Attend?

This webinar will appeal to strategic sourcing directors, sourcing managers, purchasing directors, preclinical and clinical study organizers at gene and cell therapy companies, and procurement managers at DNA and RNA vaccine manufacturers.

What You Will Learn

  • What a high-quality manufacturer does to make a plasmid under cGMP compliance
  • How the quality of plasmid DNA is designed into the life cycle of the product
  • The factors you should take into consideration for selecting a supplier to produce plasmids for your application and your phase of preclinical or clinical development

Xtalks Partner

Akron Biotech

Akron Biotech drives advanced therapy development and commercialization with high quality, industrial scale solutions. Akron’s strategic focus is supplying cGMP-compliant ancillary materials and services to enable the advancement of cell and gene therapies. These include cytokines and growth factors, human sera and purified proteins, cryopreservation solutions, plasmid DNA manufacturing and custom development services. In addition, our services and capabilities such as raw materials qualification, logistics and packaging optimization, bioassay design, validation, and regulatory services provide our customers with unique knowledge and expertise. As a regulatory compliant company (ISO certified), Akron supports clients with rigorous documentation and quality standards to fulfill their regulatory demands. Our unique capabilities allow us to seamlessly transition from R&D to preclinical and clinical development with minimal change control, and thus drive the emerging regenerative medicine sector to unmet clinical needs through affordable and seamless manufacturing options.

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