Preclinical through Phase III is a pivotal and unpredictable period for new molecules. Vetter Development Service helps smooth the path to clinic with dedicated support for key stages of development, testing, clinical manufacturing, and regulatory approval. We also help you integrate thoughtful, efficient life cycle solutions for long-term growth and success.
Vetter Development Service
Planning for success.
In early clinical development, preformulated compounds may sometimes require a higher level of support prior to process development. Vetter can work side by side with your development team to optimize preformulated API for clinical trial – as well as identify the strongest of several prequalified candidate drug formulations through compounding and filtration studies, API/material compatibility analysis, and lyophilization cycle testing. Transfer, optimization of analytical methods, and validation is also provided.
The goal of process development is to enable fast, smooth transfer of your project to commercial manufacturing. Tailored to your product’s specific requirements, process development services include: siliconization methods studies for the appropriate drug delivery system; filter compatibility testing; lyophilization cycle development; feasibility studies; engineering batches; stability and clinical batches; method transfer and clinical batches; and method transfer and scale-up for commercial, as well as validation batches.
Following confirmation of successful scale-up, clinical production begins. Key steps include compounding, filtration, preparation of primary packaging materials, and filling. Additional steps may include lyophilization, terminal sterilization, and visual inspection. Precise indicators are also generated for the master batch record.
Validation of all raw materials, bulk solutions, in-process materials, and finished product is determined by sophisticated analytical techniques. Vetter’s highly trained analytical quality control staff also provides expert support for the critical transfer of analytical methods. All instruments and methods are aligned with current international requirements.
Vetter supports you through all phases of regulatory submission. Expert technical writing and dossier preparation begins in parallel with clinical production to streamline the regulatory submission process, supported by our in-depth knowledge of global regulatory requirements, including FDA, EMA, PMDA (Japan), and PEI / BfArM (Germany).