Patheon offers expertise in GMP manufacturing of clinical trial materials to support Phase I appropriate dosage forms with fit for purpose formulations. With speed and flexibility, we are responsive to the shifting demands of early development. When you work with us, you get the benefit of our years of experience developing a broad range of molecules and the responsiveness to meet your needs.

• Phase I clinical trial material in any required batch size
• GMP manufacturing
• Small and large molecules, as well as biologics
• Adherence to U.S., EU, Japanese and other market standards
• 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

Patheon offers a range of early phase solid and sterile dose forms:

• Neat API in capsule or bottle
• Formulated powder blend in capsule or bottle
• Immediate release tablet
• Hard or softgel liquid-filled capsule
• Aseptic liquid solutions in vial
• Lyophilization

Clinical trial material manufacturing is only one element of Patheon’s fully integrated pharmaceutical development services. We have the long term 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.

If your project is especially time critical, the Quick to Clinic™ program rapidly accelerates your molecule to First Time in Human (FTIH) studies in a solid dose form using minimal amounts of your valuable Active Pharmaceutical Ingredient (API). We also offer the option of disposable equipment which eliminates the need for a cleaning method making your project faster and more cost effective.

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.