How CDMOs are accelerating development and commercialization of advanced therapies with emerging technology
Contract development and manufacturing organizations (CDMOs) have long supported the pharma industry at all stages of the medicine-making process, from R&D analytical and process development to scalable manufacturing processes, including final drug product formulation and packaging. With the rise in the last decade of new cell, gene and mRNA therapies as well as novel vaccines, the biologic therapeutics industry has demanded greater manufacturing capacity and expanded capabilities from CDMOs than ever before. CDMOs that specialize in cell therapy, like Cellipont Bioservices (CA, USA), are strongly positioned to support clients’ precise process, analytic development needs and manufacturing requirements by providing scientific expertise and operational excellence that utilize emerging technologies, thereby accelerating time to market.
Join us for this webinar, where Cellipont CSO Stella Vnook discusses how the company is investing in cutting-edge technologies and partnering with industry experts to provide its clients with seamless access to these advanced technologies that accelerate development and commercialization.
Stella will be joined by Austin Mogen, Senior Field Applications Scientist, to review how Cellipont and Corning Life Sciences (MA, USA) have worked together to build flexibility and modular technologies into their stem-cell therapy production lines. Corning is a leading innovator in materials science, applying this expertise to develop high-quality technologies for the bioproduction of stem-cell therapeutics. From advanced multi-layer vessels to a novel fixed-bed reactor, Corning supports CDMOs like Cellipont in their scale-up efforts.
This webinar was recorded on 23 February 2023.
What will you learn?
Key challenges in the cell therapy space:
- Viral vectors’ safety and cost
- Using viral vectors to edit your CAR-T and CAR-NK therapies is expensive and can also lead to adverse events in patients. It takes time and money to evaluate alternative options. What if your CDMO could help?
- Cell manufacturing scaling
- Requirements for cell expansion vary not only between cell types, but also within specific cell types, depending on their source, ability to divide [Hayflick limit] and the required batch size. CDMOs such as Cellipont utilize internal expertise and the most advanced cell-culture materials to develop optimal media formulations for the cell type and source, while companies such as Corning provide multiple cell-expansion platforms for various cell substrate and batch size needs.
- Cryoprotectant effects on cell therapy product stability and safety
- Cryopreservation using DMSO is the industry standard despite post-thaw instability in some cell types and toxicity in some patients. What if there was an alternative?
- Cell based assay variability and how to control for it
- Cell based assay robustness is challenged by the need for standardized controls that yield accurate, precise and consistent results across assay platforms and laboratories. It’s time consuming and expensive to generate materials for analytical development work. What if there could be an easier way?
Considerations and technologies for effective cell manufacturing at scale:
- Considerations for choosing a scale-up bioproduction platform
- Traditional and second-generation multi-layer vessel technology
- Integration of single-use closed-system solutions to design a robust manufacturing process
- The new Ascent fixed-bed reactor for maximizing cell culture scale-up
Speakers
Stella Vnook, R.Ph., MBA
Chief Scientific Officer
Cellipont Bioservices
Previously, Vnook has served as Chief Executive Officer of Naki Therapeutics (NJ, USA) and has been a founder of several development companies. She serves as a Board Member, C-suite Advisor and has 25 years of experience driving transformational change for global clinical development portfolios from early stage R&D to commercialization. She has an extensive background in building and managing successful start-up ventures, commercial scale-up, strategy/execution to support brand launch, R&D acceleration, IP strategy, Corporate Board selection/formation, business development/investment strategy and venture capital initiatives, as well as managed markets and healthcare economics.
Austin Mogen
Senior Field Application Scientist
Corning Life Sciences
Mogen manages a team of Field Applications Scientists that covers West USA and Latin America. Before joining Corning, he gained industry experience as a senior scientist of upstream process development and as a manufacturing supervisor for viral vector production. In these positions he focused on cell-line and bioprocess development, closed system solutions for cell culture scale-up and manufacturing of gene therapies. He and the Corning Life Sciences FAS team work extensively with process development and manufacturing groups to implement cellular scale-up conditions for viral production, cellular therapeutics and biologics.
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