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
- 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
- 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.