in vitro Assays Services

Pharmaron’s expertise with in vitro assay development and validation yields robust methods to support analysis of various kinds. Our team of experienced scientists have diverse scientific backgrounds and an extensive track record for successfully supporting cell and gene therapy (CGT) programs from discovery, preclinical to clinical.

Pharmaron offers many models, analytical techniques, platforms, compliant facilities and quality systems to support CGT programs that meet FDA, EMA and NMPA requirements.  Assay types include potency assays, cellular assays and non-cellular assays.

Relative Potency Assays

  • Potency is a critical quality attribute that should tie to the therapeutic’s mechanisms of action and link clinical efficacy to dosage.
  • Pharmaron develops and validates potency assays to support complex and/or unknown MOA, manufacturing process, variable critical quality attributes (CQAs)
  • Help support routine testing throughout process scale up and commercialization for a successful regulatory submission
  • Experience working with cell lines of multiple origin

Cell-based Assays

  • Cell based assays can be deployed to evaluate complex mechanism of actions and biochemical effects of the therapeutic target
  • Examples: neutralization antibody assay, MOA assays (e.g., enzyme activity assay), viability or in vitro toxicity assay, infectivity assay
  • Supports routine testing of biological samples throughout the preclinical and clinical phases for a successful regulatory submission

Non-cell Based Assays

  • Effect of CGT therapeutic drugs can be deciphered via non cell-based assay whenever applicable
  • Biochemical assays like therapeutic protein expression & activity
  • Biomarker or large molecule quantification
  • Cytokine assays (ELISpot)
  • Support routine testing of biological samples throughout the preclinical and clinical phases for a successful regulatory submission

Applications

  • Experience with multiple matrices: solid tissues of various nature, CSF, blood, serum, plasma
  • Core competency in de novo development and/or transfer of in vitro assays to analytically or bioanalytically support the CGT products
  • Phase-appropriate approach to support therapeutic development from IND submission to market approval (GLP, GCLP, GMP)
  • In-house clinical sample management (LIMS)
  • Electronic Data Management (ProvantisTM Data Collection Systems, SEND Data Exchange)
  • On-site biostatistician support
  • Complementary GxP master and working cell banking capabilities