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.