Why Haemtech Biopharma Services
Haemtech Biopharma Services is a division of Haematologic Technologies, Inc., which since 1987 has been providing the thrombosis research community with high-quality products and services focused on the coagulation system. HBS was built on that core expertise to provide analytical services on biotherapeutics specific to the treatment of bleeding disorders (e.g. recombinant proteins) or on those drug products that may adversely affect the coagulation system (e.g. IVIG treatments), and can bring a level of specialized knowledge not replicated anywhere else.
Quality and Compliance
HBS is a QC testing laboratory that is cGMP-certified by the European Medicines Agency, and fully inspected by the FDA. Your project can be performed to meet cGMP, cGLP, cGCP requirements and ICH guidelines. Additionally, USP and EP compliant methods can be implemented as necessary.
“The scientists and staff at HTI are truly first class in their skills and capabilities. We initially approached Haemtech to perform product release and long-term stability testing on our recombinant protein therapeutic. From the beginning, the staff at HTI quickly grasped our needs and has worked with us intensely to develop practical testing plans that meet both our deadlines and FDA quality requirements. Their scientists are experts in protein chemistry and the members of their quality department are very knowledgeable – addressing urgent quality matters along the way. The work done to date has met our needs and has often times exceeded our expectations! HTI has really allowed us to move forward with confidence, allowing us to maintain our focus of getting a quality product to the market.”
– Michael Griffith, Ph.D.
Former CEO, Inspiration Biopharmaceuticals