Center for Human Cell Therapy Boston

The TransLab is a technical and scientific platform that provides the expertise and guidance required to respond to the unique and diverse challenges presented by projects being translated into the clinic. The support provided by the TransLab focuses on optimizing and establishing the processing procedures that will be adopted in the clinical manufacturing facility. The result of a successful translational phase is to provide investigators with qualified cell manufacturing procedures, characterization assays, and pre-clinical data needed for preparation of FDA IND/IDE applications. 

Over the last 5 years the TransLab has evolved into a multifunctional unit that integrates the following responsibilities:

• Optimization of human cell manufacturing processes
• SOP development and method standardization
• Product characterization (phenotypic assays; functional assays; potency assay development; safety assays)
• Preclinical experiments
• Budget estimation
• Transfer and training of staff in the GMP facility
• Provide data and support for completion of the Chemistry and Manufacturing Control (CMC) sections of the Investigational New Drug (IND)
• Ongoing consultation