Developing the necessary proficiency to enable scalability and facilitate the advancement of the company's pipeline
Proficient sourcing of raw and starting materials
Maximizing the potential of short and rapid upstream development
We emphasize maintaining high raw material quality standards, traceability, and lot-to-lot consistency. Our top priority is compatibility with the cell platform and its intended application. Our raw and starting material partners are world-class leaders in biotechnology, ensuring that materials are safe and free from contaminants, high-quality, consistent, and regulatory compliant.
Effective donor qualification
We focus on screening a donor through a rigorous assessment of medical history, physical examination, and laboratory tests to identify potential risk factors that could compromise the quality and safety of the starting material. By targeting a consistent and reliable profile, we ensure the reproducibility and consistency of the final cell therapy product.
We focus on a practical downstream approach to prevent contamination and retain product yields, quality, and therapeutic efficacy. Our system enhances the manufacturing process's scalability and cost-effectiveness, and long-term stability.
We use microcarrier-based bioreactors to increase adherent cells, enhancing their potency, efficiency, and cost-effectiveness. In addition, our closed-system design provides a scalable, robust, and predictable manufacturing process. Our upstream development includes acceleration of research into scalable commercial processes, good manufacturing practice compatibility, and increased patient access
Efficiency in formulation for retained long-term stability
We are creating a reproducible and scalable quality-controlled upstream and downstream bioprocess cell platform tested in several non-clinical indications with excellent scientific in vitro, ex vivo, and in vivo data.
Deep and extensive know-how of the requirements and approach needed to develop an advanced therapeutic medicinal product within Good Manufacturing Practice requirements.
We have implemented the following:
Multilayer expansion to microcarrier-based suspension bioreactor scale-up
Cell biology preserving upstream approach
Optimized inoculation, seeding, and mixing approach
Formulation of drug prototype for GLP toxicology studies
Consistent profile of the cell platform throughout the batch preparation
Verified methods according to European Pharmacopeia