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Xtalks, online
2022 -11-11
Join this webinar to discuss the rapidly growing cell and gene therapy and vaccine markets, the resulting critical bottlenecks in plasmid (pDNA) production and how these bottlenecks are being addressed by collaborations and partnerships between some of the key contributors to the biomanufacturing supply chain.
Initially, pDNA was primarily used in academia and laboratory settings. Its role in the pharmaceutical industry originated in the production of therapeutic proteins, where most providers set their production dial to meet this demand. Now, however, the demand for pDNA in terms of scale and quality has been transformed by the rapid growth of the cell and gene therapy industry. Plasmid DNA is a critical ancillary material used in manufacturing these advanced therapies and this increase in demand has caused a bottleneck, since production and supply have not been able to keep up with demand.
The goal of this webinar is to provide a 360-degree view of the dynamic growth of the cell and gene therapy and vaccines market.
The Advanced Therapy Revolution: Keeping Pace with Demand
The featured speakers will discuss the increased focus of pharma pipelines on advanced therapies (over 200 INDs in 2020 alone), including the perspective of pharma to highlight their needs and the impact of bottlenecks on their R&D programs. Paramount issues include capacity, scalability, quality and continuity in the manufacturing process. Topics to be considered include: the importance of cGMP pDNA as a key ancillary material in the modern biotech manufacturing, how to deal with the pressure, the increased demand for pDNA is placing on the manufacturing supply chain and the resulting bottlenecks and their impact on the cell and gene therapy industry including long waiting lists/backlogs for pDNA (six-12 months), stalled R&D pipeline progress, damage to the expectations of the market and of future patients.
The Onus on Plasmid DNA Manufactures and their Partners: Increase Capacity/Scalability without Compromising Quality
Overview of the manufacturing process for adeno-associated virus (AAV) and highlight how Akron Bio’s new facility is designed to address the serious industry issues around capacity, scalability and quality. Discuss the cGMP quality controls and the full suite of pDNA-centered, in-house analytical development, qualification and validation capabilities. Highlight the key partnerships for genomic and proteomic characterization that are critical to ensure product quality and integrity through scale-up, as well as storage and cold-chain logistics to help increase capacity during scale-up. Take a closer look at full scale engineering and process validation capabilities enabling cGMP production, completion of clinical trials and approved therapy commercialization.
The Regulatory Conundrum: Lack of a Clear Path for All to Follow
A central challenge is the expectation that pDNA should tie into the same quality progression that occurs with the drug product as it proceeds through R&D and full GMP production, even for raw materials that contribute to the generation of the final product but are not part of it. The speakers will consider the latest concepts and information from regulators on how pDNA quality should be assessed, creating a guideline for manufacturers to work to.
Register to learn about meeting the increasing manufacturing demands of the rapidly growing cell and gene therapy and vaccine markets.
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Organized by:
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Xtalks |
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Invited Speakers:
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(Moderator) Ana Martini, PhD, Associate Director, Program Management, Akron Bio Andrea O’Hara, PhD, Strategic Technical Specialist, Next-Generation Sequencing, Azenta Life Sciences Sebastian Almeida, Senior Director of Manufacturing and CMC, Akron Bio Kurt Herzog, Director of Process Scale-up, AstraZeneca
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Deadline for Abstracts:
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2022 -11-11
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Registration:
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Free registration
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E-mail:
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ajuurinen@xtalks.com
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