Indus Biotherapeutics Research Development Capabilities


Home		Feedback		Sitemap		Contact

We are enhancing our capabilities especially in the areas of research and development..

Home » Technology Infrastructure » Research and Development Capabilities

Downstream Process Development

Different R&D Areas:

Down stream process department develops recovery and purification processes for proteins produced by recombinant bacteria, yeast or animal cells to meet the quality standards for therapeutic protein pharmaceuticals. Commercial viability, suitability to scale-up and GMP manufacturing is given due consideration while developing the processes.

Recombinant proteins expressed in bacteria are in the form of insoluble particles known as inclusion bodies. The proteins in the inclusion bodies are solubilized using denaturing agents such as guanidine hydrochloride and urea. After solubilization of the protein it is refolded and purified using various techniques. In case of proteins produced by animal cells the protein is purified from the cell culture filtrate as the protein is secreted by the cells into the medium.

The recovery and purification of the protein involves the use of various techniques such as ultra filtration and chromatography on different kinds of adsorbents. In addition, the processes for proteins derived from animal cells include viral clearance steps.

The department has the following sophisticated process and analytical equipment.

	AKTA based Chromatographic systems from GE-Health Care with flow rates 1- 200 ml/min
	Columns of various dimensions (internal diameters 1-20 cm)
	TFF apparatus
	Streamline columns for processing crude harvests
	Analytical HPLC instruments from Agilent
	Electrophoresis Instruments from BioRad and GE Health Care, Atto (Japan)

Summary

	Develops process to purify recombinant proteins expressed in bacteria, yeast or animal cells.
	Manufactures NON-GMP purified protein for non-clinical research.
	Characterizes the process and validates the process at small scale.
	Participation in scale-up design for GMP manufacturing and technology transfer.

info@indusbio.co.in