Incepta Vaccine Ltd has developed an indigenous and fully integrated bulk antigen manufacturing facility compliant with WHO GMP providing the best environmental conditions for performing the operations.
The whole facility is covering more than 50,000 square feet areas with advanced modern technologies and machineries, dedicated air handling unit and water system. A highly qualified, constantly trained team is working in this facility relentlessly for developing a new molecule.
This facility contains two distinctive floors for Bacterial and Viral bulk antigen production which are named as Bacterial Bulk suite (BBS) and Viral Bulk Suite (VBS) respectively. All suites are classified with infectious and non-infectious area. . Infectious area is maintained with negative pressure to prevent the cross contamination. It has also decontamination area for each production line, classified cold room, quarantine storage room and sterile filtration area for both BBS and VBS.
The BBS has two completely separate production trains; therefore BBS can handle two different bulk simultaneously. The capacity is substantial as our main fermenters can handle upto 1500 L volume. Both BBS and VBS can be operated in their full potential to produce significant amount of bulk vaccine to meet the demand of local market.
Bulk production facility is equipped with modern industrial scale equipments for both upstream and downstream processing. BBS and VBS have three modern production fermenters from Bioengineering. Other modern sophisticated equipments are also in place for downstream processing.
|Area of Bulk facility||Capacity of Fermenters||Major Equipments|
|Bacterial Suite-1||1500 L||Fermenter, TFF systems, Refrigerated Centrifuges,
Vessels, Akta Pilot, Ultra Centrifuge.
|Bacterial Suite-2||750 L||Fermenter, TFF systems, Dynomill,
Refrigerated Centrifuges, Vessels, Akta Pilot
|Viral Suite||500 L micro carrier based||Bioreactor, Grandstand, Akta Process,
Temperature controlled Vessels
Antigen bulk facility of IVL is going to produce