Vetter Development Service

In close collaboration with our customers, we select the drug-delivery system that suits each product. We advise on available packaging components such as stoppers, closure parts and needle-stick-prevention devices. Vetter also offers counsel on secondary packaging components, technical processes and quality requirements.

Leading up to clinical supply production, we design with our customers a product-specific manufacturing process that enables a smooth transfer later to commercial manufacturing. During this stage, we develop optimized siliconization methods for the drug-delivery system, examine the behavior of the solution and test filter compatibility. For lyophilized products, we develop lyophilization cycles and relevant methods of analysis, and conduct initial upscaling trials. Our services include feasibility studies; engineering batches; and stability, clinical and validation batches.

Clinical trial manufacturing may entail first compounding the drug substance. Next steps include filtration, preparation of primary packaging materials (e.g., cleaning, siliconization, sterilization), and filling – primarily biologics such as proteins and monoclonal antibodies. Depending on the API, further steps may include lyophilization, terminal sterilization for formulations which can be sterilized, and visual inspection of clinical supplies.

Analytical quality control comprises the testing of raw materials, packaging materials, bulk solutions, in-process materials and finished product. Our personnel are trained in state-of-the-art analytical techniques. The instruments we employ are qualified according to current guidelines, and the selected methods of analysis are validated according to international requirements.

In parallel with clinical manufacturing support, we assist our customers in preparing the documents necessary for international product registration. Vetter personnel with extensive knowledge about Vetter systems and FDA and EMA requirements assume the technical-writing tasks. When preparing the sections of the dossier needed for registration (EU/US-CTD Module 3, Drug Product Section), we approach the needs of our customers in a highly flexible manner. Our expert staff helps ensure an efficient and cost-effective approval process.