Indus Biotherapeutics Research Development Capabilities - Formulation Research


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Formulation Research

Different R&D Areas:

	Formulation and Stability Testing of Biotherapeutics refers to determination of the suitable conditions for preservation of bioactivity, safety & purity of the drug and development of the manufacturing process of the final drug product from its constituents.

	A formulation refers to the mixture of chemical substances used for preservation of bioactivity, safety and purity of a drug.

	The lab performs Pre formulation studies to screen the interaction of proteins with excipients through analytical techniques like, RP-HPLC, SEC HPLC, Dynamic Light Scattering, and UV spectrophotometry, based on3 Formulation development and Stability studies, to determine the Parameters affecting the purity, potency, safety & efficacy of the drug and test the Compatibility of the drug with the manufacturing equipment and primary packaging material, in accordance with the Regulatory Requirements.
The group is responsible for development and optimization of lyophilization cycles for biopharmaceuticals. Advanced analytical tools such as freeze drying microscopy and DSc are used for developing lyophilization cycles. Research is being pursued for developing novel drug delivery systems for biopharmaceuticals

Summary

	Preformulation studies for biopharmaceuticals.
	Compatibility studies with container closure system and manufacturing equipment.
	Development and optimization of lyophilization cycles for biopharmaceuticals.
	Trouble shooting/providing scientific solutions to drug product manufacturing.
	Development of novel drug delivery systems for biopharmaceuticals.

info@indusbio.co.in

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