From day one, we work with you to create a roadmap to manufacturability. Our platforms are designed for maximum flexibility to accommodate your specific requirements for integrated, semi-automated or fully automated production. Our in-depth understanding of cell and gene therapy manufacturing solutions enables us to swiftly resolve issues and aid your transition to a closed, integrated manufacturing environment. This complete life-cycle approach assures compatibility, reliability and quality at every stage – giving you more certainty in the outcome.

Therapeutic developers need a manufacturing strategy that will scale with their autologous or allogeneic therapy. Our integrated team of engineers and scientists work together to translate your process from the lab bench to commercial-scale production. We work with you to identify the most suitable manufacturing system for your specific therapy and develop a strategic transition plan that considers:

• Available commercial-scale processing technologies
• Short and long-term tech transfer requirements
• GMP manufacturing planning and total cost of ownership

Our cell biologists and engineers work together to assure your therapy remains unchanged by the clinical and commercial manufacturing processes. Our integrated laboratory services and applications support this effort.

• Integration of unit operations: Enables a streamlined, efficient manufacturing process.
• Process optimization: Migrates open processes to closed systems, which increases reproducibility, minimizes yield loss, and assures compliance with regulatory agencies.
• Industrialization: Creates scalable, repeatable processes to assure consistency and reliability.
• Process characterization: Includes immunophenotyping, cell expansion kinetics and residual testing to develop a well-defined, controlled, GMP-compliant manufacturing process.

Cell and gene therapy products demand consistent quality and reliable yield reproducibility. Our scientists and engineers work with you to design a solution that yields quality outputs in each unit operation. We integrate unit operations to fully automate production systems that reduce costs, variability and errors associated with manual processes.