We offer cutting-edge Bio Bulk manufacturing services at our state-of-the-art facility. Each manufacturing suite is designed for multi-product operations on campaign basis. Compliance of stringent quality norms and processes ensures highest class of containment between product change-over.

Features

1. Production area designed in consultation with international experts to ensure cGMP compliance
2. Live organisms handling in Biosafety level 2 areas with negative pressure
3. Class D (100,000) air classification of Microbial area with purification in Class C (10,000). Mammalian production suite completely with Class C (10,000) area classification
4. All open operations carried out in Class A (100) clean air stations
5. Validated utilities in each area including Hot loop WFI, Pure steam, Purified water etc.
6. Material and man movement based on unidirectional flow philosophy
7. Product dedicated chromatography columns, cross flow membranes, tubing, glassware and other soft contact parts
8. 22 independent AHUs in the production area to minimize possibilities of cross contamination
9. Cleaning validation of all multiproduct equipment for product carryover

Equipment in Biological API manufacturing

Microbial Fermentors and mammalian bioreactors with Supervisory Control and Data Acquisition (SCADA) Large volume batch centrifuge High pressure continuous flow cell disruptor Harvesting, Ultra filtration and dia-filtration set up for crossflow hollow fiber and cassette type membrane Multiple process scale automated chromatography systems

Microbial Production:

The Microbial Suite occupies an area of 950 sq. m. Production is carried out in campaign mode i.e. production of a single product in a specific room at a time. It currently houses 2 x 20 L and 1 x 50 L fermenter and purification line complementing the scale. The facility is designed to accommodate up to 150 L fermenter.

Mammalian Production:

The Mammalian Suite is 400 sq. m. It currently houses 3 x 30 L fermenters and purification line complementing the scale. The facility will be fitted with 2 x 150 L fermenter in next quarter. A new DSP suite (~ 700 sq. m) to complement the scale up for the mammalian suite is ready for operation.