Process development
Process development
Learn how we work with you to design a flexible, scalable, reproducible, and efficient manufacturing processes for your clinical program.
Support across the development cycle
At Vetter, we have extensive experience with a broad range of drug substances, customer requirements, and clinical plans. We’re experts at finding the right approach for each phase of your product’s development.
You and your product will be in skilled and confident hands at every step, from API handoff to material release. As your molecule advances, our team of technical and analytical experts will be there to help you create robust processes that not only meet your product specifications, but also readily evolve with your product.
Snapshot: Key steps in our approach to process design
Understand
We begin with an in-depth exploration of your molecule, its characteristics, and filling requirements.
Identify
We carefully match each product with an appropriate combination of processes and packaging materials.
Perform
If needed, we perform small-scale process development and optimization studies (e.g., mixing and pump studies).
Deliver
Finally, we provide mutually collaboratively created Process Development Specifications for your clinical material.
Versatile expertise
Lab scale to commercial production
While process development is a key step in clinical manufacturing, we’re always looking ahead. As we produce your clinical material, we also fill engineering, stability, and validation batches that provide crucial insights for future filling runs – and establish any new product-specific methods your molecule may need.
Our support spans your entire development cycle: from benchtop lyophilization, compounding, filtration, and packaging studies, to scaled-up evaluations in preparation for commercial manufacturing.
