Collaborative Development of a New Fill/Finish InstrumentPublished: February 24, 2020
The lack of a robust, scalable solution for autologous cell therapy fill-finish has ensured that this vital final step in the bioprocess remains fraught with challenges. Typically, industry has been forced to resort to a suboptimal, manual syringe and manifold approach.
This webinar examine the very latest technology and its capability to deliver the commercially ready, small volume fill-finish instrument required by industry. In addition, a diverse panel offering expert drug developer, CMO/CRO and tool provider perspectives explore future partnering models and methods for accelerating the novel product development process and further advancing the cell and gene therapy industry.
- Overview of a typical process for developing a new off-the-shelf instrument, including opportunities for user input
- Examples of key learnings from user feedback that had important implications in the development of a new instrument designed for use in fill/finish and other wash/concentrate/formulate/aliquot applications
- Importance of tool provider and customer early data generation
- Tool provider and contract manufacturer perspectives on the most effective ways to collaborate during instrument development and opportunities for the field to improve
Dr Alaina Schlinker, Manager, Cell Therapy Application Support, Fresenius Kabi
Alaina Schlinker has provided application support for the LOVO Cell Processing System since its commercial launch in June 2014. Alaina and her team work with customers to optimize the LOVO Cell Processing System to meet specific applications throughout the cell therapy manufacturing workflow. Alaina’s team alsoworks closely with the Fresenius Kabi R&D group, collaborating to bring customer feedback and Fresenius Kabi’s core competencies together in the development of new technology. Alaina has degrees in chemical engineering (BS from University of Southern California and PhD from Northwestern University). Her thesis research focused on in vitro platelet production from CD34+ stem and progenitor cells as alternative source of platelets for patients.
Christopher Wegener, Engineering Specialist, Fresenius Kabi
Christopher Wegener holds a Master’s Degree in Biomedical Engineering from the University of Wisconsin and currently serves as an Engineering Specialist at Fresenius Kabi. For the last 10 years, Chris has helped lead the R&D effort in designing and building the next generations of flexible, automated manufacturing systems for the cell and gene therapy industry.
David Smith, Head of Innovation and Engineering, Hitachi Chemical Advanced Therapeutics Solutions
At HCATS David combines his engineering background with the skills and techniques acquired from the Regenerative Medicine field to advance process development for the manufacture of cell therapy products. David currently is the Director of Research and Development at HCATS, where he leads two teams, the first to constantly think beyond current cell therapy manufacturing practices to help clients and the industry develop approaches that address the core challenges presented by cell-based therapies. The second team are the implementers, working on behalf of clients to build processes and analytics with these technologies for phase appropriate solutions to meet their needs, be it early stage trials, or commercially viable solutions.
Prior to joining HCATS David completed his PhD at Loughborough University in Regenerative Medicine looking at scale up approaches which allowed him to utilize his Biochemical Engineering degree from the University of Bath.
Jahid Hasan, Senior Process Development Scientist, Cell and Gene Therapy Catapult
Jahid is a Senior Process Development Scientist in the Cell and Gene Therapy Catapult’s Industrialisation team where he has spent the last 6 years developing processes across the cell therapy spectrum. He specialises in bioprocess translation with a strong focus on process automation and scale up. Jahid currently leads the core-funded differentiation programme at CGTC and is also responsible for several device development projects looking at novel downstream processing applications. He originally trained as a Biochemical Engineer at University College London before obtaining a doctorate degree in Tissue Engineering from the University of Leeds in 2014.