global cell & gene therapy manufacturing
The world of cell and gene therapy is expanding rapidly, with ever-growing market opportunities for pioneering new treatments. However, it can be difficult to commercialize new therapies given the costs involved, regulatory hurdles and scalability challenges. Drug developers need reliable, efficient and cost-effective manufacturing services with the flexibility to scale up production as needs develop.
We can work with you to overcome these challenges. With leading-edge technologies and expertise, we can help you develop and commercialize your innovative new therapy. Our scientists and engineers bring decade-long development experience across a broad spectrum of cell types and technologies. With this background, we can tailor our services in process and analytical development, manufacturing and regulatory support to meet your needs.
Our cGMP manufacturing capabilities span three technologies – autologous and allogeneic cell therapies and viral vector gene therapy. Our footprint is spread over four centers of excellence in three continents, by supporting you at all stages of clinical development and commercialization, we can help you drive your pioneering therapies to market.
|Preclinical and early phase||Late phase and commercial||Support for optimizes path to market|
|Manufacturability assessment||Global cGMP manufacturing capacity in 4 centers of excellence across 3 continents||Tissue acquisition services & MCB / WCB / MVB*|
|Process improvement & development||Global tech transfers||Customized business and operation models, facility build-out|
|Analytical assay development, qualification & validation||Formulation & fill / finish||Quality and regulatory set up for successful commercialization|
|Media optimization & development||Storage & distribution||Regulatory consulting and services|