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We provide affordable costs, efficient service and guaranteed results with first-class expertise from world-class manufacturing facilities.

 

We offer a comprehensive solution for all your CGMP manufacturing needs from a fully integrated state-of-the-art facility, with end-to-end capabilities backed by over a decade of fermentation and cell culture experience.

Designed to meet the most stringent global regulatory demands, our facility has the capability to efficiently produce your simple and complex recombinant biotherapeutics from microbial and mammalian cell culture systems.

Leveraging systems with single-use components and flow paths ensures better regulatory compliance and greater operational flexibility, allowing us to drive down the cost of your biologics.

We offer manufacturing at the following scales:

  • Microbial: A dedicated 1,000L fermenter capacity with supporting inoculum train and downstream operational trains
    • Microbial fermentation: 100L, 1,000L (stainless steel)
    • Downstream processing: Refold Tank, Disc stack centrifuge, UF/DF, Homogenizer, AKTA Pilot/Process Skids
  • Mammalian – commercial suites: 
    • Phase-1 includes two suites of 2x200l single use bioreactors.
    • Phase-2 consists of one suite of higher scale 
  • Drug product (DP) suites capable of handling pre-filled syringes, vials, devices and cartridges, including lyophilized formats

DS Manufacturing

Our 75000 sq. ft drug substance facility has dedicated suites for microbial and mammalian-based processes.

We offer conventional fermentation capability using single use equipment to increase efficiency and reduce cost in downstream processing in microbial suites.

Inherently flexible, we have the capacity and scale to manufacture for both clinical (phase I-III) and commercial requirements.

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Drug Product Manufacturing - Formulation and Aseptic Fill & Finish

High end automated filling lines integrated with isolators are in place to meet your drug supply needs for clinical or commercial requirement.

We have the capability to convert drug substance into stable formulations and fill finish in all injectable formats – PFS, cartridges and vials, including lyophilized formats.

Our automated packaging lines feature labelers, syringe assembling systems, blistering cartoning and we have dedicated warehouses with cold chain inventory management.

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Quality Control Testing

Delivering on-site cGMP analytical microbiological and physicochemical testing services to support in-process and release requirement, we also offer thorough characterization of reference as well finished product for complete analytical comparability requirements.

TESTING CAPABILITIES

  • Raw material, consumables and packaging material
  • Pen device and auto-injector related tests on universal testing machines
  • In-process and release testing
  • Analytical method validation as per ICH, US-FDA and EMA guidelines
  • Complex bioassays including cell based, immunological assays
  • Protein characterization
  • Microbiological testing and
  • Stability testing as per ICH guidelines

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Device Expertise

  • Built in capabilities to support our CDMO business for biologics drug delivery devices
  • Participate with customers right from the prototype phase for device development through to industrialization phase using our experience in the design control regulations for device development.
  • Tried and tested infrastructure to assemble (Mikron for Final assembly) & test the drug delivery devices in accordance with ISO 11608-1.

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