Shantha Biotech


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Contract Manufacturing

Infrastructure

From the very beginning Shantha has invested in building manufacturing capabilities and infrastructure to meet most stringent regulatory requirements for manufacturing of biologicals.

	•	The manufacturing suites have been designed to fulfill requirements of international regulatory guidelines for biologicals
	•	The designs have been vetted by International cGMP consultants and USFDA, as applicable
	•	Infrastructure is supported by utility blocks housing black utilities (chill water, cooling water, soft water, plant steam, etc.) and clean utilities (purified water WFI, pure steam, etc.) and other engineering services (Electrical power substation, UPS, Fire alarm system, Stand-by generator, etc.).
	•	Infrastructure is supported by cGMP Warehouse and Cold Rooms.
	•	Infrastructure is supported by cGLP Animal House.
	•	The process area layout has been evolved to meet uni-flow concept for material flow and personnel movement with the help of clean and return corridors connecting the process rooms.
	•	Separate areas for API manufacturing and fill and finish.

Our current manufacturing facilities/ capabilities are as under:-

Suite	Fermenter Sizes	Remarks
Yeast Culture Suite	2 x 500 Ltr
Suite A for Microbial fermentation	100 Ltr , 500 Ltr	Additional 2000 Ltr Fermenter is being installed
Suite B for Microbial fermentation	100 Ltr , 500 Ltr	Additional 2000 Ltr Fermenter is being installed
Suite C for Microbial fermentation	100 Ltr , 1500 Ltr	Additional 2000 Ltr Fermenter is being installed
Mammalian Culture Suite	10 Ltr
Suite D for Mammallian l fermentation (under construction) for antibodies	2 x 650 LtrAlso equipped with 30 and 100 ltr fermentors	Will be ready by March 2006
Fill & Finish suite	Equipped with high speed liquid filling
Fill & Finish suite (Suite E) under construction	To be equipped with high speed liquid filling with freeze drying in vials. Also provided with prefilled syringes and UnIject system	Will be ready by March 2006
Pilot	2 x 30 Ltr	One of the 30 Ltr is being replaced with 100 Ltr.