Learn from CRB’s subject matter experts covering critical, relevant topics in pharmaceutical manufacturing–challenges we solve today will be solutions we implement tomorrow.
Multi-modal ATMP facilities to satisfy growing demand
Tuesday, April 28th at 12 pm EST
Charles Heffernan and Emily Thompson
This webinar will focus on how to deliver multi-product Advanced Therapy Medicinal Product (ATMP) facilities to adapt to an evolving product pipeline.
Between newly developed products, strategic partnerships, and acquisitions in the ATMP market, companies are racing to find or create capacity for viral vectors, gene modified cell therapies, and monoclonal antibodies.
A dedicated manufacturing facility can be costly, and limits options for the future. Why not have a facility that can produce multiple product types to allow for adaptability to an evolving product pipeline?
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Vaccines—our best long-term defense
Wednesday, April 29th at 12 pm EST
Rob Boulanger and Marc Pelletier
Not a treatment but a cure. The 1918 influenza (Spanish Flu) pandemic was the most severe pandemic in recent history, where 1/3 of the human race was affected by this avian H1N1 flu virus and roughly 15-20% of those infected died. If not for improvements in health and science, the SARS-CoV-2 pandemic would likely have affected far more individuals and the lethality rate would certainly have been much higher. Influenza viruses still claim the lives of over 50,000 Americans every year. This number could be reduced dramatically if everyone received their influenza vaccines every year. Vaccination, when possible, provides the best long-term defense against viral and bacterial infections and subsequently a pandemic, by preparing our body’s own infection defense system.
The types of vaccines, the methods of manufacture and the safety profiles have improved dramatically since Edward Jenner first injected 8 year old James Phillips in 1796. The time between the identification of the pathogen and the manufacture of potential vaccine candidate has been reduced from years to weeks. Multiple platforms exist within our biopharmaceutical companies providing several potential candidates for a commercial product. Many of the cell culture based biopharmaceutical manufacturing facilities in existence today lend themselves well to vaccine manufacturing, providing a huge potential for large scale manufacturing in response to a pandemic. Rob Boulanger will provide a case study example of how equipment used in a typical mAb facility could be used for large scale manufacturing of a SARS-CoV-2 Vaccine.
Join us to learn how to reconfigure what is available in your production arsenal and scale it safely while rapidly deploying it in a GMP compliant way takes a nimble and responsive team of experts.
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4 strategies of successful project execution
Thursday, April 30th at 12 pm EST
Mike Barrett and Carl Rohs
Industry leaders are questioning how to quickly evaluate new and repurposed drugs while simultaneously readying their operations for rapid transformation. Novel partnerships between private R&D teams and public health agencies are emerging to address the “discovery” half of that equation, which leaves company leaders to grapple with the other half: how can they prepare their operations for commercial-scale manufacturing of a therapy that hasn’t yet been identified or approved?
The solution is a radically lean approach to capital project delivery. This approach relies on a multi-disciplinary team of industry experts, whose combined technical knowledge is rocket fuel for even the most complex projects. While your drug discovery activities continue, this team can get to work, quickly freeing potential throughput capacity in your existing operations and/or engaging trade partners in order to set a facility expansion initiative into motion. By initiating this lean delivery approach early in the process, you’re helping to ensure that when your therapy is ready for commercial manufacturing, your facility is ready, too.
Join us to hear how the four pillars of successful project execution will save you time, money and most importantly, get therapies to patients faster.
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Viral vectors—beyond the yellow brick road
Tuesday, May 5th at 1 pm EST
Jan Bondoc and Peter Walters
The science of viral vector manufacturing is generating a lot of excitement, and companies in this space are under pressure to move fast and make cost-effective decisions; this can occasionally result in speed at the expense of due diligence. To design a facility that’s not just capable of making the science happen at a commercial scale, but that’s also capable of operating smoothly, cost-effectively, and in a production environment that’s designed for maximum efficiency requires a close examination of assumptions and decisions.
Join us to achieve a more fulsome appreciation of the interdependent factors that contribute to an efficient and reliable throughput of viral vector products at a commercial scale.
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Developing new tools in the pandemic response toolbox
Wednesday, May 6th at 1 pm EST
Jake Adams
The ideal pandemic response must include a pharmaceutical approach, both vaccines to prevent new infections and treatments to address those infected. The ideal vaccine and treatment is rapidly developed and deployed, adaptable to the specific pandemic, safe, and stable.
This presentation will discuss how new siRNA and mRNA modalities could be deployed as treatments and as vaccines respectively, and the potential advantages they could offer to traditional approaches. The ongoing efforts to develop these therapies for COVID-19 will be discussed as well as the presently existing hurdles. If COVID-19 has come too early for these platforms to reach their infectious disease fighting potential, then it should serve as the start of the development process, not the end.
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