Our capabilities

Integrated CDMO capabilities for complex pharmaceutical products

From biologics and sterile injectables to drug-device-combination products and soft gelatin capsules, OneSource delivers integrated development and manufacturing capabilities designed to support complex therapies from concept through commercialization.

Our platform combines formulation science, analytical expertise, scalable manufacturing, and regulatory alignment within a coordinated global network of facilities. This enables clients to move programs forward with greater speed, continuity, and operational control.

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Built to support complexity across the product lifecycle

Complex pharmaceutical products demand more than isolated services. They require alignment across development, manufacturing, quality, and supply.

At OneSource, our capabilities are structured to support this full lifecycle through integrated teams and facilities that work together across stages and modalities. Whether supporting early development, technology transfer, clinical manufacturing, or commercial supply, we provide a connected model designed to reduce risk and accelerate execution.

End-to-end development and manufacturing support

Lifecycle Stage Core Capabilities
Development Formulation development, process development, analytical method development
Scale-Up & Tech Transfer Process characterization, QbD strategies, validation support
Clinical Manufacturing Sterile manufacturing, biologics production, packaging
Commercial Supply Large-scale manufacturing, fill-finish, device assembly
Lifecycle Management Process optimization, analytical support, regulatory alignment

Specialized capabilities across high-value modalities

OneSource focuses on technically demanding pharmaceutical products where development, manufacturing, and delivery require advanced expertise and infrastructure.

Biologics

Integrated biologics development and manufacturing across microbial and mammalian platforms, supporting recombinant proteins, monoclonal antibodies, biosimilars, and next-generation biologics.

Capabilities include:

  • Drug substance and drug product manufacturing
  • Biologics analytical services and characterization
  • Upstream and downstream process development
  • Fill-finish and device-ready delivery formats
Explore our biologics capabilities

Drug-device combination products

Integrated development and manufacturing for drug-device-combination products designed to improve usability, adherence, and patient outcomes.

Capabilities include:

  • Autoinjectors and pen systems
  • Device integration and assembly
  • Human factors and usability support
  • Final packaging and patient-ready delivery systems
Explore our drug-device combination capabilities

Sterile injectables

Development and manufacturing of sterile injectable products requiring advanced formulation, process control, and device integration.

Capabilities include:

  • Liquid, emulsion, lyophilized, and dry powder injectables
  • Sterile fill-finish and aseptic manufacturing
  • Lyophilization cycle development
  • Pre-filled syringes, vials, and cartridge systems
Explore our sterile injectable capabilities

Soft gelatin capsules

High-volume softgel formulation and manufacturing capabilities supporting complex oral delivery systems and bioavailability enhancement strategies.

Capabilities include:

  • Lipid-based and poorly soluble formulations
  • Advanced encapsulation technologies
  • Multiple softgel formats and release profiles
  • Commercial-scale manufacturing and packaging
Soft gelatin capsules

Integrated infrastructure supporting global supply

OneSource’s capabilities are supported by a network of specialized facilities designed to align development and manufacturing across modalities.

This infrastructure enables:

  • Co-located development and manufacturing
  • Scalable capacity across product types
  • Reduced tech transfer complexity
  • Global regulatory compliance and inspection readiness

Together, these facilities provide the operational flexibility and control required to support both emerging and established pharmaceutical programs.

Quality and regulatory expertise embedded across our operations

Quality and regulatory alignment are embedded across all OneSource capabilities, from analytical development through commercial manufacturing and submission support.

Explore our quality approach

A partner for complex pharmaceutical development and manufacturing

OneSource is built to support pharmaceutical companies developing technically demanding products that require specialized expertise, integrated infrastructure, and scalable manufacturing.

By combining development, manufacturing, analytical, and device capabilities within a connected operating model, we help clients move complex programs forward efficiently and confidently.

Explore our resources

Access a curated collection of materials designed to provide insights into our capabilities and expertise across the drug development and manufacturing lifecycle.

Explore resources

Start your therapeutic program with OneSource

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