Facilities

Specialized facilities supporting complex pharmaceutical manufacturing

OneSource’s global network of manufacturing and development facilities is designed to support complex pharmaceutical products across the full product lifecycle.
From biologics process development and sterile injectable manufacturing to softgel production and dedicated beta-lactam operations, each facility is purpose-built to support specific modalities, technologies, and stages of development. Together, they form an integrated infrastructure platform aligned to deliver scalable manufacturing, operational flexibility, and global regulatory compliance.

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An integrated network designed for complex products

Complex pharmaceutical products require more than manufacturing capacity alone. They require infrastructure capable of supporting specialized processes, coordinated technology transfer, and consistent execution across development and commercial supply.

At OneSource, our facilities are designed to work together as a connected network, enabling:

Alignment between development and manufacturing

Flexible scale-up pathways across modalities

Reduced operational complexity and transfer risk

Integrated quality and regulatory oversight

This model allows programs to move efficiently from development through global commercialization.

Infrastructure across the product lifecycle

Facility Focus Core Functions
Development Facilities Process development, analytical characterization, scale-up studies
Manufacturing Facilities Drug substance and drug product manufacturing, fill-finish, packaging
Specialized Production Sites Softgel manufacturing, beta-lactam containment, sterile injectables
Integrated Delivery Systems Device assembly, prefilled systems, patient-ready packaging

Integrated DS & DP Facility

A multi-modality manufacturing site supporting biologics, complex injectables, and drug-device-combination products through integrated drug substance and drug product operations.

Key capabilities include:

  • Microbial and mammalian biologics manufacturing
  • Sterile fill-finish and lyophilization
  • Device assembly and packaging
  • Commercial-scale manufacturing infrastructure
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Global R&D Facility

A research & development center supporting process optimization, analytical development, and scale-up readiness.

Key capabilities include:

  • Microbial and mammalian process development
  • Scale-up studies and process characterization
  • Advanced analytical development
  • Technology transfer support
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Sterile Injectables Facility

A specialized sterile manufacturing facility supporting liquid, lyophilized, and device-integrated injectable products.

Key capabilities include:

  • Aseptic and terminally sterilized manufacturing
  • Lyophilized vial production
  • Prefilled syringes and autoinjector integration
  • Sterile fill-finish operations
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Penicillin Injectable Facility

A dedicated beta-lactam manufacturing facility designed for safe, segregated production of sterile penicillin products.

Key capabilities include:

  • Sterile dry powder vial filling
  • Dedicated beta-lactam containment infrastructure
  • Controlled manufacturing environments
  • Global supply support for essential antibiotics
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Soft Gelatin Facility

A dedicated high-volume manufacturing facility supporting complex oral dosage forms and advanced softgel technologies.

Key capabilities include:

  • Commercial-scale softgel manufacturing
  • Advanced encapsulation systems
  • Multiple release formats and packaging configurations
  • Automated inspection and quality control systems
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Built for global compliance and reliable supply

All OneSource facilities operate under integrated quality systems aligned with global regulatory expectations.

Across the network, facilities are approved by leading regulatory agencies including:

  • US FDA
  • EMA
  • MHRA
  • TGA
  • Health Canada
  • ANVISA
  • WHO

This regulatory foundation supports reliable supply into highly regulated global markets while maintaining consistent quality and operational control.

Infrastructure supporting scalable growth

OneSource’s facilities are designed to support both emerging and commercial-stage programs, enabling clients to scale efficiently while maintaining continuity across development and manufacturing.
By combining specialized infrastructure with integrated operational oversight, OneSource delivers the flexibility, control, and manufacturing depth required for today’s increasingly complex pharmaceutical products.

Explore resources and insights

Stay informed with the latest insights, industry perspectives, and technical resources from OneSource. Explore content designed to support informed decision-making across development, manufacturing, quality, and commercialization.

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