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HT’s services are offered from discovery through commercial GMP release of large molecule therapeutics.  Not your typical large molecule CRO, HT has a specific depth of expertise in large molecule analytics, manufacturing process support, and navigation of the complex regulatory pathways from IND to BLA.  Our services de-risk and speed your new drug development process. 

HT’s scientific experts are well known in the fields of protein chemistry, advanced High Resolution Mass Spec (HRMS), Immunology, hemostasis, and novel assays to support complex large molecule therapeutic development and manufacture.  Our FDA-inspected facilities operate to the highest standards of GMP compliance.

Characterization of Large Molecules by Mass Spectrometry

Custom Assay Development and Validation

Analytical Development, GMP Release, Stability

  • Drug Substance and Drug Product 
  • Complex Analytical Development and phase appropriate validation
  • GMP validated assay and compendial assays for release testing (clinical and commercial)
  • Stability Indicating Methods and GMP Stability studies 
  • Impurity Identification 

Biologics Process Support

  • Plasma Fractionation – deep expertise in isolation of products from plasma
  • Downstream purification development in mAb and protein production
  • ID of process impurities and remediation strategies.
  • Host cell protein commercial kit evaluation of fit for purpose
  • Platform or process-specific HCP ELISA development for routine lot release testing
  • Evaluation of HCP antigen standards 
  • Critical reagent manufacturing and lifecycle support of validated assays

Other Services

  • Impurity identification and process remediation in antibody therapeutics
  • Custom Antibody and Antigen development for novel immunoassays
  • Critical Reagent development and manufacture
  • In-silico modeling for hemostasis
  • Customized blood collection tubes for trials 
  • Development of custom clinical sample preservation formulations
  • Manufacturing and packaging of custom collection devices
    • Protease stabilizer to prevent degradation of small molecules to support tox, PK/PD, and clinical studies
    • Formulations to protect circulating tumor cells