Process development for every clinical phase
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
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.
Substance classes we support
Formulation support
From the first steps of clinical development, we work side by side with your team to optimize formulation candidates for trials – and also to identify the strongest prequalified candidate drug formulations for successful validation.
We can support formulation development for even the most complex, highly sensitive molecules, which can often be a challenge in early phases.
Continued process verification
When we design your processes, we think ahead to reproducing them at commercial scale. Using our Quality by Design (QbD) approach, we’ll collaborate with you on a customized program for capturing the data, knowledge, and documentation you’ll need at the next step in your product’s life cycle: formal submissions for product registration and approval.
Our clinical manufacturing services
