Follow a proven, predictable path to cGMP manufacturing and reliably take your product to market
Our New Product Introduction (NPI) program maps out your entire journey to commercialization. It accounts for each key milestone with checkpoints to ensure you meet all required quality standards as your therapy progresses towards commercialization. The NPI program leverages our heritage and longstanding experience in establishing cGMP manufacturing standards, combining both corporate and local quality standards, customized for cell and gene therapies, to de-risk your journey to commercialization.
You will also maintain complete oversight during your product’s lifecycle journey, enabling you to assess and validate the quality of process robustness, raw materials, analytical methods, sterility, facility, equipment, and tissue acquisition throughout this journey.
Anticipate and address potential concerns from regulators by focusing on your therapy’s manufacturing process
Our established, compliant facilities and processes enable you to leverage facility layouts, airflows, material storage, documentation processes and quality systems that have already proven to be suitable for commercial manufacturing and have passed regulatory agency inspections for other cell and gene therapies.
As a result, you can focus on your product’s manufacturing process to withstand the scrutiny of regulatory inspections, while relying on us to complete the regulatory compliance checkpoints at the facility where it is hosted. By minimizing risks to commercialization in this way, you will be able to avoid major rework, delays and related costs that could lead to a significant business loss.
Our capabilities
Our cGMP manufacturing capabilities span three technologies – autologous and allogeneic cell therapies and viral vector gene therapy and our footprint spreads across three continents. We can support you at all stages of clinical development and commercialization to help you drive your pioneering therapies to market.
Preclinical and early phase |
Late phase and commercial |
Support for optimized path to market |
Manufacturability assessment |
Global cGMP manufacturing capacity across 3 continents |
Tissue acquisition services, Cell and viral banking |
Process improvement & development |
Global tech transfers |
Customized business and operation models, facility build-out |
Analytical assay development, qualification & validation |
Commercialization readiness |
Quality and regulatory set up for successful commercialization |
Media optimization & development |
Formulation & fill / finish |
Regulatory consulting and services |
Formulation & fill / finish |
Storage & distribution |
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