Vetter Development Service

In close collaboration with our customers we select the drug delivery system and components that suit each particular drug. We advise on available packaging components such as stoppers, closure parts, and safety solutions against unintended needle pricks; on and secondary packaging components: and on the technical processes and quality requirements for packaging systems.

In the phase leading up to clinical production, we design a product-specific manufacturing process together with the customer. During this stage, we develop optimized siliconization methods, examine the behavior of the solution and test the filter compatibility. For lyophilized products, we develop lyophilization cycles and relevant methods of analysis, and conduct initial upscaling trials. Feasibility studies; engineering batches; and stability, clinical and validation batches serve to test the feasibility and quality of the various dosage forms over time.

Clinical manufacturing entails the compounding of the supplied active drug. According to the type of drug, the steps that follow may include filtration, preparation of the primary packaging materials (i. e., cleaning, siliconization, sterilization), and filling for different therapeutics – primarily biologics such as proteins and monoclonal antibodies. Depending on the active drug, further steps may include lyophilization, terminal sterilization for formulations which can be sterilized, and visual inspection for aseptically prefilled products.

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-phase support, we assist our customers in preparing the documents necessary for the international product registration. Vetter personnel with extensive knowledge about the Vetter systems and the 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 can help assure you an efficient and cost-effective approval process.

When the clinical phases have been completed, Vetter Development Service staff transfer your products to commercial production.
Link: Vetter Commercial Manufacturing

e.g. pre-filled Water for Injection (WFI) syringe