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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

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