Integrated drug substance (DS) and drug product (DP) facility

A fully integrated site for development through commercial scale manufacturing

Spanning more than 450,000 square feet, OneSource’s flagship site is designed to support the full lifecycle of complex therapeutics, from process development through commercial scale manufacturing as a premier global CDMO partner.

By uniting drug substance and drug product manufacturing within one FDA-inspected CDMO site in India, OneSource enables a more controlled and efficient path from development to market, reducing risk while accelerating timelines.

Built for multi-modality execution at scale

The co-location of fill-finish and drug substance manufacturing enables faster progression from bulk production to final dosage form, reinforcing OneSource’s integrated drug substance & product model while reducing transfer complexity and improving scheduling efficiency.

The facility is engineered to support multiple high-value modalities within one integrated infrastructure:

  • Biologics (DS & DP) across microbial and mammalian platforms
  • Drug-device combination products, including prefilled and self-injection systems
  • Sterile injectables, including sterile liquid and lyophilized formats
Explore our biologics capabilities

Integrated drug substance manufacturing

Biologics drug substance manufacturing is supported by both microbial and mammalian platforms, enabling flexibility across molecule types and development strategies.

Microbial Manufacturing Infrastructure

Microbial Manufacturing Infrastructure

  • 1 × 1000L stainless steel fermenter
  • Integrated homogenization and centrifugation systems
  • Chromatography systems (AKTA / Hanbon) with process-fit column sizing
  • Tangential flow filtration (TFF) systems
  • Dedicated pre-culture, media, and buffer preparation suites

Mammalian Manufacturing Infrastructure (Single-Use Platform)

Mammalian Manufacturing Infrastructure (Single-Use Platform)

  • 2 × 2000L single-use bioreactors
  • Depth filtration and chromatography systems (Pall / Cytiva)
  • TFF systems and viral filtration capabilities
  • Dedicated upstream support suites for media and buffer preparation
This combination of stainless steel and single-use systems allows the facility to support both process robustness and operational flexibility, while enabling efficient scale-up and tech transfer.

Drug product and fill-finish capabilities

Drug product manufacturing is fully integrated within the same site, supporting a range of sterile formats and delivery systems.

Fill-finish and packaging capabilities

  • Cartridge, prefilled syringe, and vial filling (liquid and lyophilized)
  • Tofflon filling line integrated with isolator and lyophilizer
  • Bausch + Strobel filling line with Steriline isolator
  • High-speed vial filling and packaging lines
  • Secondary packaging capacity up to ~100 cartons per minute

Working range

  • Cartridges: 1.5ml – 180 cartridges/min
    1.8ml – 180 cartridges/min
  • Prefilled syringes: 3.0ml – 140 cartridge/min
  • Pen and Autoinjectors: 1.0ml long with needle shield 10 x 16 format – 124 syringes/min
  • Vials: 50 vials/min for 10ml vial size

Infrastructure designed for scale and operational reliability

The site is supported by robust utility and infrastructure systems designed to maintain consistent performance across manufacturing operations.

Key systems include:

  • Multiple high-capacity boilers supporting clean steam generation
  • Centralized cooling systems and HVAC infrastructure for controlled environments
  • High-capacity warehouse with cold chain inventory management
  • Environmental control systems supporting classified manufacturing areas

This infrastructure enables reliable, large-scale production while maintaining strict environmental and process control.

Quality control and analytical integration

Quality systems are fully embedded across all operations, supported by on-site analytical and microbiology laboratories.

Core quality and control capabilities include:

In-process and release testing for drug substance and drug product

Continuous environmental monitoring across classified areas

Active air sampling, settle-plate monitoring, surface monitoring, and environmental isolate identification

Automated visual inspection across packaging operations

This integrated approach ensures that quality is maintained at every stage, from development through commercial manufacturing.

Designed for speed, flexibility, and reliable execution

The flagship site is built to support accelerated timelines while maintaining consistency and compliance.
By integrating development, manufacturing, and assembly within a single operational framework, OneSource provides end-to-end CDMO support for complex biologics, drug-device-combination products, and sterile injectables. This allows programs to progress efficiently, even as requirements evolve.

Learn more about our quality & compliance

Global Standards, Proven Compliance

The facility operates in alignment with global regulatory expectations and has been inspected and approved by leading health authorities.

Facility Approvals

  • ANVISA
  • EMA
  • EU GMP
  • T FDA
  • US FDA
  • ZaZiBoNa

Address

Division Plot # 2-D 1, Obadenahalli,
Doddaballapura, 3 rd Phase
Industrial Area, Doddaballapura Taluk
Bengaluru Rural District – 561203, India

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