Flagship facility for biologics, drug-device combinations and complex injectables

Dedicated facility for a range of therapeutic modalities

Covering over 450,000 square feet, our flagship facility in Doddaballapura, Bengaluru, India, is a powerhouse of biologics drug substance and drug product development and manufacturing. Using both microbial and mammalian platforms, we fast-track development and scale commercial production in multiple fill-finish formats. With dedicated capacities for drug-device combination and complex injectables, we can develop aseptic sterile products in a range of formats, from cartridges to liquid vials. Our highly automated facility delivers process development through clinical and commercial manufacturing at flexible scales, tailored to your exact requirements.

Integrated development and manufacturing capabilities 

Drug substance manufacturing capacities:

Microbial facility

  • 1X 1000L stainless steel fermenter  
  • Homogenizer (GEA) and centrifuge (GEA) integrated with fermenters  
  • Low and high-pressure chromatography with process fit column sizing (AKTA process/Honbon); TFF systems (PALL); Lyophilizer (Tofflon) 
  • Dedicated pre-culture suites, media and buffer preparation rooms 

Mammalian facility 

  • 2X 2000L bioreactors  
  • Depth filtration, chromatography systems with process fit column sizing (PALL/Cytiva); TFF systems (PALL) 
  • Filtration: Viral filtration, ultrafiltration and diafiltration 
  • Dedicated pre-culture suites, media and buffer preparation rooms 

Drug product manufacturing capacities:

  • Drug product capacity- 40 million cartridges, 28 million pre-filled syringes, 4 million vials (liquid and lyophilized) 
  • Tofflon filling line integrated with isolator and lyophilizer 
  • Bausch Strobel filling line integrated with steriline isolator 
  • 2 Boilers of the capacity of 3000 kg/hr and one of 5000kg/hr 
  • Cooling tower with a capacity of 100 TR and 4 HVAC chillers of capacity 330 TR 
  • Secondary packaging operations at a capacity of 100 cartons/ min 
  • High-capacity warehouse with cold chain inventory management 

Quality control

Our on-site analytical and microbiology labs power comprehensive in-process and release testing operations. We track every product quality parameter with precision, from in-process checks through drug substance and drug product release. Our fully automatic packaging line runs with 100% visual inspection at every step.  

We’re relentless about contamination control – running continuous utilities testing and environmental monitoring through active air sampling, settle plate observation and surface monitoring in classified areas. Our isolators come equipped with built-in active air samplers that meet all regulatory requirements, and we identify every environmental isolate and investigational organism down to the species level. 

Facility approvals

USFDA

EUGMP

 

Address

Plot # 2-D 1, Obadenahalli, Doddaballapura

3rd phase Industrial Area, Doddaballapura Taluk Bangalore Rural District,

Karnataka, India 561203.

Fast-track your next biologics and combination drug products to market

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