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Why HT?

We are THE Protein Science experts

  • 20+ years of proven expertise in large molecule characterization
  • Referenced in thousands of publications in peer reviewed journals
  • Scientific leadership includes world-renowned Protein science experts
  • Advanced high resolution mass spec (HRMS) services
  • Host Cell Proteins (HCP), Peptide Mapping, Intact Protein Characterization, De-Novo Antibody Sequencing, Capsid Characterization, Clone Selection.
  • Orthogonal methods with multiple modalities for HCP detection using HRMS and Ligand Binding Assays
  • Advanced Biomarker Assay Development and Validation

Our Services Bridge Both Product and Clinical Development Domains

Product Development:

  • Experts in large molecule characterization, analytical development and validation, release and stability testing.
  • Process and yield-improvement expertise to support biologics manufacturers.
  • Large molecule drug substance/drug product Impurity characterization, quantification
  • Platform-specific and process-specific ELISA assay development for routine HCP detection during lot release

Clinical Development:

  • Development and validation of specialized bioanalytical methods to evaluate pre-clinical and clinical patient samples
  • De-novo assay development and validation including immunoassays, Antidrug antibodies (ADA), Neutralizing Antibodies (NAb), 
  • Dose verification and monitoring of activity in pK samples
  • Focus on development of assays from complex matrices

Integrated Services From Discovery to Commercial Release

  • Proven CMC and regulatory expertise from IND through BLA
  • Full FDA-inspected, cGMP operations, including GLP, CLIA certification.
  • Continuity of services to eliminate tech transfers
  • Deep expertise in the development of Critical Quality Attributes (CQA’s)
  • Phase-appropriate development approach to speed your program

HT is THE Preeminent Expert in the Science of Blood

  • Globally recognized experts in coagulation, hemostasis and the assessment of Hemostatic risk (applies to both large and small molecule development!)
  • First company to validate commercial Thrombin Generation Assay (TGA)
  • Go-to partner for hemophilia, IVIG, anti-coagulants, and other blood-related indications
  • Leading developer and manufacturer of plasma reagents; thousands of publications citing HTI.
  • Custom formulation of protease inhibitors and anticoagulants to ensure preservation of drug compounds in blood samples for toxicology, PK, and PD studies.
  • Manufacturer of customized collection devices including blood collection tubes to ensure the integrity of your biomarkers for analysis.

Deep Science Performed With Urgency

  • Committed to helping our sponsors bring safe and effective therapeutics to the patient as quickly as possible.
  • Scientific staff that understands the importance and urgency of your program
  • The “right sized” CRO; A partner that is fast, responsive, and flexible
  • Streamlined and integrated analytical services bridging early development into clinical-stage validated assays.
  • Collaborative and consultative approach to guide informed decision making on analytical suitability of assays and methods.