PTHeptech, a leader in sulfated polysaccharide research, responded to the 2008 Brazilian health crisis by identifying problems with traditional bovine heparin and developing safer alternatives. The company advanced these innovations through rigorous R&D, scale-up processes, and intellectual property protection, while providing expert services and support to the pharmaceutical industry.
Heptech advances from basic research to seeking marketing partnerships for its products:
Problem Identification
As experts in sulfated polysaccharides, we tackled the 2008 Brazilian health crisis triggered by the withdrawal of bovine-origin heparin from the market, a discovery we made. This event highlighted issues with using traditional bovine heparin and explained its limited use globally.
Diagnostic Analysis
In-depth analysis comparing standard heparin to the variant implicated in bleeding incidents identified the latter as bovine-origin. This variant had a unique structure leading to lower anticoagulant effectiveness, necessitating increased doses and different interactions with the protamine antidote, likely causing the bleeding events.
Research and Development (R&D)
Recognizing the issues with bovine heparin, our R&D focused on overcoming these challenges. Years of research resulted in a safe bovine heparin (SBH) comparable to porcine heparin (as acknowledged by FDA specialist DOI 10.1055/s-0039-1685164), a pharmacopeia-compliant bovine low molecular weight heparin (B-LMWH), and an innovative low anticoagulant heparin that reduces tumor growth and metastasis (LABH).
Scale-up Processes
Following our R&D product’s development, we scaled up our innovative product line with help from various fellowships, grants from FAPERJ, SENAI, and SEBRAE, and our own resources. This strategy generated crucial data and insights, facilitating collaboration with potential production partners.
Intellectual Property (IP)
Protection To defend its inventions from competitors, Heptech filed patents in Brazil and internationally. These include patents for various methods of producing Safe Bovine Heparin (SBH), cost-effective Bovine Low Molecular Weight Heparin (B-LMWH) manufacturing, and the novel low anticoagulant heparin that has been demonstrated to reduce tumor growth and metastasis.
Industry Services and Support
Heptech’s extensive experience has enabled us to offer specialized technical services to the pharmaceutical industry. We have conducted a range of quality control analyses for crude and IPA eparin, as well as for low molecular weight heparin (LMWH) samples. Our services include general QC analysis, analytical method validation and comparability studies, aiding companies in meeting their regulatory compliance requirements.
