BIOTECHNOLOGY

Our Biotech R&D department is supported by a group of highly competent scientists involved in the development of complex recombinant products. Anti-D IgD molecule and complex molecules such as FSH are innovator products for the team. With proven credentials in Cell culture, Fermentation, Purification, Formulation development and Analytical testing, the team has leveraged its expertise to ensure recombinant therapeutics are characterised from validated processes.

This team of scientists plays a pivotal role in developing products that , are transferred to our manufacturing facility for commercial production. The team has successfully developed several molecules which are at different stages of commercialisation. Starting with Biosimilars, the progression is structured to the development of hormones, antibodies and proprietary and innovative recombinant biopharmaceuticals in varied thrust areas.

CAPABILITIES

We have the capabilities to develop complex recombinant products, biosimilars and first in the world recombinant protein human therapeutics in injectable forms. Our efforts are directed towards biopharmaceutical drug development in these four principal domains:

Molecular Biology

Path breaking research involving discovery and development of various therapeutic proteins utilizing recombinant DNA technology. These include:

• Microbiology and Strain Improvement
• Biochemical Engineering
• Gene Cloning and Expression

Process Sciences

BSV’s Biotech R&D has a strong development team with following expertise:

• Cell line development
• Cell culture and Fermentation development (Upstream)
• Purification (Downstream)
• Scale-up operations
• Formulations
• Analytical method development
• Characterization
• Stability studies
• Tech Transfer to Manufacturing facility

Non-clinical Research

Our scientists undertake toxicology and pharmacology studies and provide assurance of safety in molecules under investigation. We plan, develop and work based on global regulatory requirements. Our scientists work closely with our business development team to generate innovative concepts and ideas, exploiting both market needs and synergies across therapeutic areas.

Clinical Research

Our Clinical research team has several years of experience in doing clinical research on recombinant hormones and antibodies.

INFRASTRUCTURE

Our labs are fully equipped with advanced instruments for extensive physico-chemical and bioanalytical product characterization. Our biotech department is equipped with state of the art specialized equipment to carry out development and analysis of Recombinant Therapeutics and Antibodies:

Cell culture & Fermentation:

• Autofill Cryocan
• Controlled temperature Kryoplaner
• SS In-situ Bioreactor
• Benchtop Glass Bioreactors
• Biosafety Cabinets
• Sterile Thermoplastic Tube Welder
• Micro Weighing Balance
• Carbon Dioxide Incubators
• Peristaltic Pump for low & high volume dosing
• Steam Sterilizer equipped with HPHV technology
• Dynamic Passboxes
• Cooling Centrifuge
• Inverted Microscope
• Nova Bioanalyzer
• Infors Orbital Shakers

Purification (Downstream Process):

• AKTA Prime Plus Chromatography systems
• High end Chromatographic Resins
• High end Chromatographic Columns
• Sartoflow SMART Labscale TFF system for Diafiltration/Ultrafiltrationy
• Nanofiltration Assembly Unit
• Cooling Centrifuge Machine
• Weighing Balances
• Masterflex Peristaltic Pumps
• Diaphragm Pump

In-house Analytical Infrastructure:

• HPLC systems (with UV, PDA, Fluorescence detectors)
• Multimode ELISA Plate readers (UV/vis, fluorescence, luminescence)
• UV-VIS Spectrophotometer
• Electrophoresis assemblies (PAGE, Isoelectric focussing)
• iBlot (dry blotting system)
• Gel doc system
• Plate washer
• Micro-weighing balance
• Vacuum concentrator
• Cooling microcentrifuge
• Water baths/dry baths
• Fume hood
• Stability chambers