Haemtech Biopharma Services (HBS) is a leading cGMP-compliant, QC testing laboratory that specializes in providing analytical services for biopharmaceutical manufacturers producing recombinant and plasma-derived protein therapeutics with emphasis on those affecting the hemostatic system. HBS enables its customers to satisfy regulatory and quality testing requirements to bring their drug candidate from development to commercialization.
The demand for biopharmaceuticals is growing, and the industry is rapidly adopting outsourcing strategies as a way to meet escalating regulatory oversight. With its extensive experience in hemostasis, HBS is well positioned to assist developers of drug products affecting the coagulation system.
HBS’s testing services revolve around two main areas: general QC testing for stability and release of a drug product, and identifying deleterious side effect potential such as immunogenicity, thrombin generation (for IVIG drugs) and host cell protein contamination in recombinant products. HBS performs the development, validation and implementation of assay methods specific to your product in our cGMP-certified laboratory.