Trans Lab | Overview
Our mission is to help physicians treat their patients by bridging science and medicine. To accomplish this objective, we support bench-to-bedside and bedside-to-bench translational and clinical research. We operate in two major areas:
- laboratory assays for investigator-initiated clinical and translational trials
- process and product development (PPD) of assays and biological reagents to support clinical trials.
The TransLab builds on a decade of experience and expertise in clinical trial support, initially as part of the Center for Human Cell Therapy. The laboratory moved to Boston Children's Hospital in 2012. The work performed in the TransLab is SOP-driven, quality and regulatory compliant and properly documented.
Partners & collaborators
- Harvard Stem Cell Institute
- Connell and O'Reilly Families Cell Manipulation Core Facility (Dana-Farber Cancer Institute)
- Boston Children’s Hospital Translational Research Program (TRP)
- The Boston Children’s Hematologic Malignancy Program (DFCI) and Division of Hematology/Oncology
- The Boston Children’s Clinical & Translational Study Unit (CTSU)
- The Dana Farber/Boston Children's Cancer and Blood Disorders Center Gene Therapy Program
Working with the TransLab team
The TransLab is a flexible and adaptable platform that works with investigators involved in clinical and translational research. We are a dedicated team responsive to individual project requirements and mindful of timelines.
Our cell processing development platform is open to investigators within and outside the Harvard University system as well as to industry. Pricing depends on the scope of work or the type of assay or project, so we work one-on-one with our investigators to establish the budget.
Scope of services
Clinical trial support
We offer a comprehensive battery of cellular and molecular assays to help guide personalized therapy or support patient monitoring. We can assist with simple, routine processes as well as complex, non-routine laboratory developed tests. Our goal is to support your specific clinical research needs whatever they may be and we have significant experience in developing new assays and/or transferring assays from a research laboratory context into a validated format for clinical trial support.
Here are some examples of previously performed assays theTransLab has used to support clinical trials:
- Density gradient separation & cryopreseravation of mononuclear cells
- Large scale cell selection (CliniMACS®) from mobilized peripheral blood or apheresis products
- DNA and RNA extraction
- Flow cytometry-based immunophenotyping, cell population isolation and functional assays (cytotoxic assay, proliferation, apoptosis)
- Molecular assays: PCR, qPCR, cloning, RNA Seq library preparation, Southern blot
- Predictive, prognostic or PD biomarkers analysis using plate-bound immunoassays: ELISA or multiplex immunoassay (Luminex MAGPIX®)
If there is no off-the-shelf solution available, we work with investigators to develop and/or implement customized tools and assays. Contact us with your specific needs.
Process and Product Development
We provide an integrated process and product development platform that delivers:
- Robust and validated cell manufacturing procedures
- Product-specific characterization profile with product release target specifications to ensure product safety, identity, purity and potency
- Post-manufacturing logistics: final formulation, packaging and shipping
- Standard Operating Procedures (SOP) and Batch Production Record (BPR)
- Regulatory support, including generating the Chemistry, Manufacturing, and Controls (CMC) section of the Investigational New Drug (IND) application, help answering product manufacturing and characterization questions in the clinical protocol
- Technology transfer to GMP manufacturing facility
Clinical trial support
As we are broadening the scope of our services, here are some examples of the type of support for phase I/II trials we are currently providing.
- Molecular monitoring of patients enrolled in clinical trials
- Biomarker profiling by ELISA
- Phenotypic and functional cellular assays to evaluate alloreactivity in a haplo transplant setting
- Immunomonitoring studies
Process and Product Development for Cell Therapy
The TransLab has deep experience working on a diverse pipeline of projects covering the fields of cancer therapy, regenerative medicine and gene therapy. As of today, the TransLab has enabled 11 clinical trials. Some notable examples include:
- Cancer therapy
- Allogeneic unrelated umbilical cord blood, expanded with PGE2.
- Epstein-Barr virus specific T cell therapy for nasopharyngeal carcinoma.
- In vitro expanded autologous invariant natural killer T cells in cancer.
- MART1-specific CTLs for melanoma.
- Use of Regulatory T cells and IL-2 to treat steroid-refactory chronic graft verus host disease
- Regenerative medicine: Cultivated Autologous Limbal Epithelial Cells (CALEC) use of lung derived mesenchymal progenitor cells for the treatment of advanced emphysema.
- Gene Therapy: There are exciting new developments in the field of autologous transplant of genetically modified hematopoietic stem/progenitor CD34+ cells. The TransLab has played a key role in the development of clinical trials for several genetic deficiencies:
- X-linked Severe Combined ImmunoDeficiency (X-SCID), Wiskott-Aldrich Syndrome (WAS), X-linked Chronic Granulomatous Disease (X-CGD), Childhood Cerebral Adrenoleukodystrophy (CCALD).
The TransLab is located in the heart of the Longwood Medical Area in the Enders building. It is part of the Translational Research Program within the Institutional Centers of Clinical and Translational Research at Boston Children’s Hospital:
61 Binney Street
Enders 208 (Office)
Enders 428 (Laboratory)
MAIL STOP: BCH3096
Boston, MA 02115