Manufacturing

PROFICIENT BIOSOURCING AND SCALABLE IN-HOUSE MANUFACTURING

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 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.

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.

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.

Proficient sourcing of raw and starting materials

Effective donor qualification

Maximizing the potential of short and rapid upstream development

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.

BIOPROCESS DEVELOPMENT

• Multilayer expansion to microcarrier-based suspension bioreactor scale-up

• Cell biology preserving upstream approach

• Optimized inoculation, seeding, and mixing approach

• Consistent profile of the cell platform throughout the batch preparation

• Verified methods according to European Pharmacopeia

• Formulation of drug prototype for GLP toxicology studies

We have implemented