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Patheon Overview Brochure

Clinical trial material manufacturing for late development

Patheon offers expertise in GMP manufacturing of materials to support Phase II and III clinical trials, as well as product registration. We always work with the goal of developing a formulation and processes that are suitable for scale-up and large-scale manufacture on automated equipment.

Features of Patheon clinical trial material (CTM) manufacturing for late development:

  • Phase II & III clinical materials and registration batches
  • GMP manufacturing
  • Small and large molecules, as well as biologics
  • Comprehensive range of solid and sterile dose forms
  • Adherence to U.S., EU, Japanese and other market standards
  • Over-encapsulation and matching placebos
  • Full CTM formulation
  • Quality by Design process development
  • Manufacturing, packaging and release testing
  • Chemistry, Manufacturing and Controls (CMC) documentation for NDA

Clinical trial material manufacturing is only one element of Patheon's fully integrated pharmaceutical development. We have the deep experience and broad resources to take your molecule all the way from early development to commercial supply. Our scientists always work with the final product in mind, and our facilities are designed with a commonality of equipment from CTM to commercial. All this allows us to scale your product seamlessly through all phases of development and ultimately to commercialization with exceptional speed and efficiency.

Case Study: Taking Formulations to the Next Level

The Challenge Transfer a manufacturing process from a client/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 QbD (Quality by Design) 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.

Ask The Experts

Anil Kane, Ph.D., MBA

Anil Kane, Ph.D., MBA
Dr. Kane has more than 25 years of experience in the science and business of taking molecules throug
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Robert A. Lipper, Ph.D.

Robert A. Lipper, Ph.D.
Having ushered multiple products to market though the entire development process, Dr. Lipper is an e
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Joseph A. Fix, MBA, Ph.D.

Joseph A. Fix, MBA, Ph.D.
With 30 years of experience converting discoveries into businesses, Dr. Fix holds 24 patents, includ
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John S. Kent, Ph.D.

John S. Kent, Ph.D.
With over 35 years of experience, Dr. Kent offers expertise in overcoming development challenges for
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K. George Mooney, Ph.D.

K. George Mooney, Ph.D.
Dr. Mooney has 35 years’ experience in pharmaceutical sciences and exploratory drug development. He
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Lynn Van Campen, Ph.D.

Lynn Van Campen, Ph.D.
With more than 30 years of drug development experience, Dr. Van Campen is an expert in the establish
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Tony Pidgeon

Tony Pidgeon
Mr. Pidgeon has nearly three decades of experience in the formulation and process development of ste
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