Rapid biotechnology development at any stage of your journey
Whether you are looking for a complete cell and gene therapy system development partner or assistance with a specific challenge, our biotechnology experts can help you. Some of the common challenges we support our clients with include:
Route to market planning
In your route to market strategic planning stage, our experts work with stakeholders and key opinion leaders (KOLs) to provide you with an optimized roadmap for your therapy development. We are adept at balancing the confounding interests of regulatory compliance, manufacturing, clinical validation and product development, to help you find the best path to commercialization.
Small batch manufacturing for early clinical trials
If you’re looking for support with small batch manufacture for early clinical trials, we can rapidly produce cost-effective prototypes with high instrumentation, allowing you to identify and control what matters (CQAs & CPPs). Our focus is on ensuring scalability and robust product quality as you progress to later stage clinical trials and production.
Post market support
Once you have successful instruments or products on the market, there are often still many opportunities for improvements to your cell and gene therapy system. Our experts help you identify and integrate the right post market upgrades for your needs, be it integration of PAT into an established manufacturing platform, cost-down analysis, or technical troubleshooting.