Services
The City of Hope Center for Bio Innovation and Manufacturing leverages more than 20 years of experience in GMP manufacturing to accelerate the translation of cell and gene therapies from research concepts to Phase 1/2 clinical trials. Our facilities support both internal programs and external collaborations with academic institutions and biotechnology companies. We offer a combination of established platform processes and bespoke manufacturing development to advance novel therapeutics.
Contact:
[email protected]
The City of Hope Translational Development Center (TDC) was established in 2018 to provide a “one-stop shop” to support the translation of innovative preclinical ideas, guiding the development of investigational products from pre-clinical proof-of-concept to phase 1 clinical trials. TDC provides resources including training, product development, manufacturing, regulatory filing, and clinical testing for the development of novel therapeutic entities from small molecules to cell and gene therapy products. TDC has operationalized these processes to serve academic partners as well as small to medium sized corporations.
Contact:
Nojan Namakian
[email protected]
The City of Hope Office of IND Development and Regulatory Affairs has extensive experience and a strong track record with IND submissions for cellular and gene therapy, biologics and small molecule products for early phase clinical trials. The team provides regulatory strategy, planning, and application preparation, as well as manages and coordinates engagement with regulatory agencies for both internal programs and external collaborators, including academic institutions and biotechnology companies.
Contact:
Catherine Cortez
[email protected]
As part of City of Hope’s Center for Gene Therapy, the Laboratory for Cellular Medicine (LCM) is an academic translational laboratory dedicated to the design, pre-clinical assessment and early clinical development of novel cell and gene therapies. A key focus is the development and qualification of integrated, closed-system processes for clinical-scale drug product manufacturing, including standardized analytical methods. Our goal is to enhance efficiency, increase automation, and reduce production costs.
Contact:
Angelo Cardoso
[email protected]