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Clinical Manufacturing

Process Development

Expertise in all aspects of process design and development

Expertise is the key to manufacturing processes that meet your exact specifications. We can work with you to create processes that are flexible, scalable, reproducible, and efficient. 
 

Formulation support

We work side by side with your development team to optimize formulation candidates for clinical trials as well as identify the strongest prequalified candidate drug formulations for successful validation. Vetter can even support your formulation development with the most complex, highly sensitive molecules, which can often be a challenge in the early phases.
 

Process design

Vetter has experience with many types of processes for drug manufacturing, including processes based on either single-use or multi-use equipment, using different pump systems (rotary piston, peristaltic, or membrane pumps) and sterile filtration types. Vetter subject matter experts will review your manufacturing process and create an agreeable design specification document and process development plan.
 

Lyophilization cycle development and optimization

Our lyophilization services start during the early clinical phases, so we can optimize and fine-tune your lyophilization cycle for commercial manufacturing. The aim of lyophilization cycle development is to arrive at a scalable process that is both technically and economically feasible for cGMP manufacturing. Above all, the process needs to be scalable and robust enough for the product to meet agreed-upon specifications. 
 

Process qualification/continued process verification

Process qualification determines if the process design is capable of reproducible commercial manufacturing. Vetter’s Quality by Design (QbD) approach to process design provides understanding and control of parameter variability for the formal validation needed for market registration and submission. Data collected in the course of the design phase can support your formal submission. We monitor critical quality issues during manufacturing and evaluate longer-term improvements to the process. We work with you to design a custom Continued Process Verification program with an agreed-upon set of parameters and specifications.