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Manufacturing

Patheon offers a full range of services and expertise in GMP manufacturing of high-quality materials for all phases of clinical trials.

Early-Phase Clinical Supply

  • Phase I and IIa clinical trial material in any required batch size
  • GMP manufacturing
  • Small and large molecules, as well as biologics
  • Broad selection of phase-appropriate solid and sterile dosage forms
    • Neat API in capsules or bottles
    • Formulated powder blend in capsules or bottles
    • Immediate-release tablets
    • Hard or softgel liquid-filled capsule
    • Aseptic liquid solutions in vial
    • Lyophilized vials
  • Over-encapsulation and matching placebos
  • Materials for dose escalation studies
  • Scalable formulation and stabilization
  • Small-batch manufacturing, packaging and release testing
  • Chemistry, Manufacturing and Controls (CMC) documentation for North American and European registrations

Late-Phase Clinical Supply

  • Phase IIb & III clinical trial materials and registration batches
  • Comprehensive range of solid and sterile finished dosage forms
  • Adherence to U.S., EU, Japanese and other market standards
  • Over-encapsulation and matching placebos
  • Accelerated scale-up and tech transfer processes
  • Quality by Design process development
  • Manufacturing, packaging and release testing
  • Chemistry, Manufacturing and Controls (CMC) documentation for NDA

Case Study: Clinical Supply in Just Four Months

The Challenge: A customer came to Patheon with a time-critical need for Phase I clinical trial material.

The Solution: Patheon developed a prototype formulation and confirmed its short-term stability.

The Outcome: In just four months, Patheon successfully developed, manufactured and packaged material for a Phase I clinical study.

Case Study: Taking Formulations to the Next Level

The Challenge: Transfer a manufacturing process from a customer/CMO site, and propose improvements to formulation.

The Solution: After a successful tech transfer, we revised the formulation and process to improve the product’s stability, scalability and manufacturability. We also prepared a risk assessment plan, conducted several statistical Design of Experiments (DoE) under a Quality by Design (QbD) plan, manufactured registration batches and prepared regulatory documentation.

The Outcome: The project was completed on time and on budget, and the customer successfully filed a robust CMC package with their NDA submission.

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