Expanded Capabilities add to HTI’s Growing Large Molecule Bioanalysis Services Business
September 30th, 2020 Essex Junction, VT –Haematologic Technologies (HTI), a leading protein chemistry company providing products and analytical services supporting the research, development, and commercialization of large molecule biotherapeutics, today announced the addition of a High Resolution Mass Spectrometry (HRMS) lab headed by Kevin Van Cott, PhD, a global expert in the use of HRMS for Host Cell Proteins (HCP) and biotherapeutics characterization. Dr. Van Cott will also be a key member of HTI’s Medical and Scientific Advisory Board. The addition expands HTI’s already strong offerings in the field of large molecule bioanalysis across various platforms including off the shelf and custom ligand binding assays of biotherapeutics, immunogenicity, and advanced hemostasis assessments.
“I am excited to progress my relationship with HTI as they will provide both stability and growth. Formalizing a partnership with HTI will allow us to provide critical safety information to a much larger number of biotherapeutics developers,” said Dr. Van Cott.
HTI is well known and highly regarded for both its CMC and Drug Development support services across a wide variety of protein biotherapeutics. The addition of the HRMS laboratory positions HTI as a world leader for Host Cell Protein assessment and mitigation. Combined with Dr. Van Cott’s scientific expertise, HTI is uniquely positioned among only a small number of companies who have this depth of HRMS expertise in the large molecule space.
“I am thrilled to have Dr. Van Cott join our scientific team. His deep knowledge and skills are in perfect alignment with HTI’s stringent focus on science, customers and regulatory excellence. Patient safety is paramount in drug development. The recent advances in High Resolution Mass Spectrometry have made it an essential technology to support HCP identification and quantification in drug substance and drug products to ensure potentially harmful immunogenic impurities are absent in drug substance and related products. Our comprehensive offerings, which include off-the-shelf and custom HCP ELISA, consulting support services for HCP mitigation, and high throughput HRMS positions HTI as a world leader in Host Cell Protein analysis.” said Jean Pineault, President and Chief Executive Officer.
About HTI’s HRMS / ELISA platforms:
Using both ELISA and HRMS platforms, HTI provides identification and quantification of specific HCPs in biotherapeutic products from early development (cell line selection), through to cGMP release testing of large molecules from pre-clinical to commercialization. Additionally, using HRMS, HTI can verify critical quality attributes (CQAs) for biotherapeutics via peptide sequencing, post translational modification profiling including key modifications such as N-glycosylation, O-glycosylation, acetylation, methylation, sulfation, phosphorylation, among others. Combined with its expertise in potency and kinetics assays, HTI is the service provider of choice for biotherapeutics development and manufacturing.
About Haematologic Technologies:
Haematologic Technologies (HTI), a leading protein chemistry company providing products and analytical services supporting the research, development, and commercialization of large molecule biotherapeutics, The company’s biopharma services are performed in fully compliant, FDA-inspected GMP/GLP/CLIA facilities. Building on its 30+ years of expertise in plasma proteins, hemostasis, and blood coagulation, HTI is also a leading global supplier of coagulation research reagents (plasma proteins and antibodies), custom formulated in vitro Diagnostics/Point of Care (IVD/POC) device reagents, and customized blood collection tubes for clinical trials. Visit us at www.haemtech.com.
HTI’s deep expertise in protein chemistry services four distinct market segments. 1) CMC: supporting cell line optimization, host cell proteins, drug substance/product characterization, stability & release, enzyme and coagulation factors replacement therapies among others from early development to commercialization; 2) Drug Development: Pharmacokinetics, potency, and immunogenicity assays supporting drug development from discovery, preclinical, clinical to post marketing; 3) Plasma Derived Protein Therapeutics: plasma protein expertise including hyperimmune plasma products and release testing; 4) Specialized Clinical diagnostic Reagents: manufacturing and services around coagulation and other biologic reagents for research and diagnostics.