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.

GMP process development with hand holding cartridge

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 icon, step one in our approach to GMP process development

Understand

We begin with an in-depth exploration of your molecule, its characteristics, and filling requirements.

Identify icon, step two in our approach to GMP process development

Identify

We carefully match each product with an appropriate combination of processes and packaging materials.

Perform icon, step three in our approach to GMP process development

Perform

If needed, we perform small-scale process development and optimization studies (e.g., mixing and pump studies).

Deliver icon, step four in our approach to GMP process development

Deliver

Finally, we provide mutually collaboratively created Process Development Specifications for your clinical material.

Filling vials on a filling line for a GMP process development workflow
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

Oligonucleotides icon

Oligonucleotides

Monoclonal antibodies icon

Monoclonal antibodies

Fusion proteins icon

Fusion proteins

Peptide hormones icon

Peptide hormones

Coagulation factors icon

Coagulation factors

More molecules icon

Many more molecules

Lab workers conducting formulation tests

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.

Process qualification and verification

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.

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Learn more about our services

Reach out to our expert team to discuss how we can support you. 

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