Optimization of cryopreservation to enable intensification of biopharmaceutical processing and cell-based product supply
Current Projects
- Development of a platform for the purification of viral vector systems for the manufacture of vaccines and gene therapies
- Monitoring and optimization of cell culture media preparation to support bioprocess intensification
- Optimization of cryopreservation to enable intensification of biopharmaceutical processing and cell-based product supply
- Role of autophagy in bioprocessing
Cryopreservation is a key unit operation in biologics, vaccine and advanced therapy medicinal products (ATMPs) production. Quality controlled cell banks are essential to ensure that biological processes start with a consistent cell population. This is a fundamental process control measure to guarantee that product of consistent quality can be produced across many batches. With the advent of cell-based therapies, cryopreservation is also critical in order to enable transport of an efficacious product to the patient. The trend towards process intensification in vaccine and biopharmaceutical production and the advent of cell therapies is driving a need for robust, reliable cryopreservation and revival of larger volumes moving from the traditional 1 – 2 ml cryovial up to 500 mL in cryobags. There are significant challenges associated with increasing the volume to be frozen: longer exposure to toxic cryopreservants eg DMSO, generation of ice crystals which can damage the cell, loss of viability due to oxygen and/or nutrient depletion during holds etc. Optimization of this unit operation is key to unlocking the potential efficiency gains.
The current approach to developing cryopreservation is generally iterative and empirical, with little fundamental understanding gained and no certainty that the final process is optimum or robust. This project utilizes both modelling and experimental approaches to optimize cryopreservation, looking at the most impactful parameters such as cooling rates, cell type, cryopreservant, volume, cell density etc. to build process understanding and optimize the process. The impact of the cryopreservation process on a variety of cell lines including CHO and MSC cells will be studied over the duration of the project.
Project funding: SSPC, the SFI Research Centre for Pharmaceuticals & UCD SCBE Start-up Scheme
PhD Researcher: Maycou Soares Zamprognio
PhD Supervisor: Jessica Whelan