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The Process Diagnostic - How to optimize the technology transfer and the development
A critical aspect of cell therapy industrialization is process development. It is all about how to industrialize the cell therapy product within short time frames. MaSTherCell has developed a process diagnostic tool to help put together the development plan. Mathieu Anceau, Technology Transfer Supervisor at MaSTherCell, tell us more about it. He explains how creating a strong process diagnostic lays the foundations for a successful technology transfer and development towards a process fit for industrialization.
- Complying with strategic timelines
- Controlling production process costs
- Fulfilling regulatory, QA and QC requirements
- Setting up a Quality Control strategy
- Ensuring a reliable manufacturing
Our Solution & Results
Our role is to develop a process that will address the long term industrialization of the therapy keeping in mind the GMP requirements and the costs. This will set in place a long term vision of the cell therapy. The goal is to develop a process that is scalable, cost-effective and reliable.
The very first step to build a development is the process diagnostic which is used to optimize the technology transfer and to put together the development plan. Its objective is to define the project and assess the current manufacturing and analytical processes with the aim of recommending optimizations in order to prepare for the clinical study.
Scale-out stem-cell-based process using hollow fiber bioreactor
Athersys is a clinical-stage biotechnology company engaged in the discovery and development of therapies designed to extend and enhance the quality of human life. The company develops allogeneic cells to treat multiple disease conditions of cardiovascular, neurological, inflammatory and immune diseases.
For its product candidate, Multistem®, Athersys was looking for a reliable partner to develop a large scale expansion process, using the Quantum® hollow-fiber bioreactor system (Terumo). The goal of this study was to demonstrate the ease of extending first yields achieved with batches obtained from one bioreactor (approximately 1 x 109 cells/batch) to batches obtained from 10 systems while maintaining essential cell quality. In addition, through efficient tech transfer and process optimization a second objective was to significantly reduce the number of operators needed in the process.
Our Solution & Results
The consistency in the transition from a single Quantum hollow-fiber bioreactor system (Terumo) to a scaled, 10-Quantum process was successfully demonstrated, in only sixteen weeks. Two sequential batches of 9 to 10 x 109 cells were produced, using ten Quantum systems, with 100% of the cells that were released. The cell expansion process was kept equal at 6 days. Thanks to process optimization, the seed stock was reduced by 20% and media consumption was reduced by 10% in the context of a new cell bank and new reagent batches. In addition, the 900% increase in process capacity was maintained by two technicians (FTE). Combined with process automation and optimization, this ultimately led to a 40% reduction of the cost of goods. This offers the perspective to further multiply the 10-Quantum system process to produce progressively larger batches, when commercial manufacturing and clinical demand increases.
Development of dendritic cell-based therapy that suppresses immune response
ImCyse is a spin-off from the Catholic University of Leuven (KUL), founded in 2010. ImCyse is developing therapeutic vaccines to treat immunological disorders.
ImCyse was looking for a reliable partner to outsource the manufacturing of its autologous cell-based immunotherapy to treat multiple sclerosis, from process scale-up (10 - 50x) and GMP-compliancy translation to the release of the product for clinical trials (Phase I). As an autologous product with strong inter-individual variation, the dendritic cell preservation and maturation, as well as T-Cell survival and amplification, are critical. The fresh cell products have short shelf-life (product stability of 6 hours at ambient temperature), and require the implementation of adapted and robust process control and analytics.
Our Solution & Results
We started by integrating ImCyse specifications, protocols and documentations within our QA system. This allowed us to select and validate the right suppliers and starting materials to meet our client's requirements and ensure a fast and safe release of their product. We used GMP or pharma grade materials that were systematically tested using our QA/QC systems. No antibiotics were used.
The process was designed to be compliant with GMP standards and was successfully scaled from R&D batches to clinical trial materials in less than 3 years.