The one single factor behind our success so far has been our focus on building and evolving our Research and Development competence. Today, our research laboratory extends over a sprawling 15,000 sq. ft. with a constant flow of filtered air and centralized air – conditioning. Equipped with the state of the art instruments, it is recognized by the Department of Scientific and Industrial Research (DSIR), Government of India.
Research & Development
Specialists in Recombinant DNA products, our expertise extends over –
- Cloning of Genes in various expression systems
- Process optimization and scale-up of Protein Expression
- Downstream Processing (Protein purification, Protocol Development and Characterization of Proteins)
- Fermentation Technology
- Tissue Culture Assays
- Contract Research Services
Efficient production of recombinant proteins mean relying on intelligent protein expression systems. This becomes very important if the protein is to be expressed using an active ingredient of human or animal. At Sudarshan Biotech plasmids are designed for high expression levels of target proteins and on request, tailor made expression systems can be developed.
Sudarshan Biotech also addresses the following critical factors during bacterial fermentation like: media composition, oxygen supply, feeding strategy, time of induction, growth rate, by-products, product variants etc. Based on these parameters, robust and scalable fermentation protocols resulting in high product yields are developed which are readily transferable to contract manufacturers working according to GMP standards. At Sudarshan Biotech, fermentation equipments are designed upto a scale of 50-100 liters culture volume, which allows production of several kilograms biomass for subsequent recovery of the target proteins.
Protein Purification
Purification of proteins can be done from various sources like: E. coli, Pichia Pastoris and Mammalian cells. Cell disruption, purification, and polishing steps are also done. For this purpose we choose the appropriate purification methods/principles to remove all undesired contaminants such as host cell protein (HCP) and pyrogens / endotoxins and DNA. Precipitation and filtration methods, affinity, ionic exchange, hydrophobic interaction, hydroxyl apatite and size-exclusion chromatography etc. are applied. Optimized reports and necessary documentation are given as they are mandatory for approvals by regulatory authorities.
Seven Stages Of Protein Process Development
The development of a production process can be divided into at least seven different stages:
- Genetic engineering using expression vectors
- Optimization and characterization of host vector systems
- Fermentation process optimization and scale up
- Down stream processing
- Product and process related analysis
- Scale up
- GMP Process transfer
Physicochemical Analysis
- Electrophoresis (SDS-PAGE, Western Blot)
- HPLC (reversed phase, size exclusion, ion exchange)
- Spectroscopy (UV-VIS, fluorescence, circular dicroism)
- N-terminal sequencing
Biochemical Analysis
- Determination of DNA contamination and host cell impurities (Threshold™ system)
- Determination of the endotoxin content
- Enzyme assays to determine and quantify the catalytic activity of the target protein
- Determination of the protein content and activity by ELISA
Adding power to our research labs are the latest systems like:
Ultracentrifuge; -80 C freezer and -20 freezer; PCR machines; Sonicators; Incubator Shakers; Lab Scale fermentors; Gel Documentation system; DNA sequencer; Milli-Q- Water purification unit; Lyophilizer; Several Laminar flow-hoods, Walk-in cold room; Fully Air conditioned – 37.5 Tons Generator – 125 KVA – 3 seconds backup for sensitive equipment; UPS-10KVA
Production Facility - Antigens
We have state of art and c GMP compliant P2 manufacturing facility for the production of various Recombinant products. This Facility is designed to address the need for wide portfolio of products.
The Facility is equipped with Autoclaves, Dry Heat sterilizer, -86 deg C Deep Freezer, Laminar Airflow unit(Lafu), Shaker Incubator, Vortex mixture, Seed Fermentor, Production Fermentor, High Speed Centrifuges(Continuous & Batch), Dynomill , Ion Exchange Chromatography, Di filtration and Ultra filtration systems and Lyophilizer.
We have fully automated fermentors to control all key process parameters
Such as p H ,Temperature, Dissolved Oxygen and dosing of nutrients. The process starts by fermenting E.coli followed by cell harvesting . The Cell free liquid is purified by different stages of Downstream process and converted to final products. The Quality of the products are on par with International standards and the quality is ensured during all times by using Multiple purification steps including Ion Exchange chromatography. The intermediate steps and final steps are processed in high quality, electro polished steam and sterilizable equipments in Classified environments with restricted entry through multiple Air locks.
The Entire process is automated, maintained and controlled by Trained Personnel.
Contract Research Services
At Sudarshan, we combine a wide range of protein technologies and integrate them with the state-of-the-art systems to give our customer, their choicest product. The customers are encouraged to be a part of the protein based drug / product development process.
Customized solutions can be delivered, irrespective of the project size.
Our Contract Research Services cover:
- Efficient E. coli and Pichia Pastoris systems
- High cell-density fermentation
- Scale-up
- Protein purification
- Protein characterization
- Protein production processes
- Protocols and documentation
Multi-Product Facility
A state of the art multi product production facility in Hyderabad catering to regulated and semi regulated markets will be operational by the year 2009-10. The concept study for the facility has been completed in January 2008 by Biozeen (Project consultants). The project implementation would commence from March 2008. This facility would be used for the manufacturing of commercial quantities of Bio-pharmaceuticals apart from Industrial enzymes
