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Case Studies

We have an outstanding track record working and successfully resolving challenges, from process and assay development to manufacturing and implementing robust quality systems.

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Scale-out stem-cell-based process using hollow fiber bioreactor

Scale up Optimization Production Tech Transfer Quality Control

Background

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.

Challenges

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

GMP Translation Production Tech Transfer Quality Assurance

Background

ImCyse is a spin-off from the Catholic University of Leuven (KUL), founded in 2010. ImCyse is developing therapeutic vaccines to treat immunological disorders.

Challenges

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.