Principal Domains
Gvone's R&D efforts are directed towards biopharmaceutical drug development through 3 principal domains:
Process Sciences
Biologicals: Our biological development group is very strong and has developed processes for multiple products, including Insulin, Streptokinase. In this department, we develop cell lines, fermentation/purification/scale-up/ formulation processes and analytical methods to meet global regulatory standards.
Small Molecules(Fermentation): Leveraging our core fermentation expertise, we are continuously researching and developing a range of microbial-derived pharmaceutical products for disease areas spanning cardiovascular, diabetes, nephrology, inflammatory and oncology. The processes we develop are robust and scalable, from fermenter sizes, 1 ltr to 115,000 ltrs.
Chemistry: Small molecule pharmaceuticals play an important role in Gvone's R&D programs. We leverage our expertise in chemical synthesis to improve manufacturing productivity for existing products and introduce new generics into our pipeline. Under development are several generics for the anti-infective, oncology and immunosuppressive domains.
Non-clinical Research
Our scientists undertake toxicology and pharmacology studies to establish proof of concept and provide assurance of safety in molecules under investigation. We plan, develop and execute studies based on global regulatory requirements.
Clinical Research
We develop clinical protocols for several novel drugs in our pipeline. We conduct well-designed studies which include assessment of novel biomarkers to derive maximum information about the safety and efficacy of our molecules in clinical trials. We interact with clinical researchers and physicians in major clinical centers globally to use up-to-date clinical knowledge in designing and analyzing our clinical studies..