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Cell & Gene Therapy Workshop:
Discussion Workshop: Latest Innovations in the Application of Osmolality in Cell and Gene Therapy Development and Manufacturing
Thursday, 08 July 2021 | 14:00 BST (UTC+1)
KENDAL STUDD, Scientific Application Specialist, Advanced Instruments, Horsham, UK,
Dr. ADRIEN SOULA, Process Development Scientist, The Cell and Gene Therapy Catapult, London, UK
LUCIA MARANI, Analytical Development Scientist, Oxford BioMedica
- Presentation 1:
The value of osmolality in cell and gene therapy development and manufacturing
Presented by KENDAL STUDD, Scientific Application Specialist, Advanced Instruments, Horsham, UK
- Presentation 2:Hot Off The Press- Impact of Osmolality during the AAV manufacturing process
Presented by DR. ADRIEN SOULA, Process Development Scientist, The Cell and Gene Therapy Catapult, London, UK
- Presentation 3:Using Osmolality within Cell and Gene Therapy Analytical Development
Presented by LUCIA MARANI, Analytical Development Scientist, Oxford BioMedica
Cell and gene therapies can potentially revolutionize the treatment of incurable diseases. Clinical successes and recent drug approvals have fuelled ongoing investments in this exciting area of therapeutic research, with over 1000 therapies in clinical trials at the end of 2020. Despite this, challenges remain to be solved in order to make these novel drugs accessible to larger patient populations. For now, downstream recoveries are as low as 5-30% for viral vector production, depending on the process. Manufacturing capacity, production yields, and supply chain logistics continue to be an area of focus for improvements. The key to improvement and success is through implementing high quality process design and process parameters to ensure robustness and reproducibility. An important question for scientists in the area is”, What tools and checks can be implemented to ensure consistent product and process control”? Osmolality is a measure of solute concentration and has long been considered a critical measurement in Biopharma describing how much of a solute is present in a given solution. More recently, osmolality has been shown to be strongly implicated across the entire gene therapy upstream and downstream process workflow. It’s clear for example that in vector production, osmolality is a factor affecting vector stability and transfection and is useful as a process parameter for reducing the potential for AAV aggregation during UF/DF filtration processes.
In today’s workshop, we’ll hear the latest from Kendal Studd of Advanced Instruments about the range of ways in which an osmolality measurement can improve efficiency and recovery within the CGT process.
Next, Dr Adrien Soula of the Cell and Gene Therapy Catapult will present data from a study, started in January 2021, to assess the impact of using osmolality readings in the production of a specific AAV