Vetter Development Service
•Product Sheet: Vetter Development Service
Achieving more through partnership: Vetter Development Service
Vetter Development Service accompanies your product from its clinical development through its market launch. The tailoring of the application system to your active substance accelerates the time-to-market and maximizes your market impact.
Services:
Development of Primary Packaging Materials:In close cooperation with our customers we select the application systems and components that suit each particular drug. We advise our customers on available packaging components such as stoppers, closure parts, safety solutions against unintended needle pricks and secondary packaging components, as well as the technical processes and quality requirements for packaging systems.
Process Development:
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:
Clinical manufacturing entails the compounding of the supplied active drug. According to the type of drug, the process steps that follow may include filtration, preparation of the primary packaging materials (i. e. cleaning, siliconization, sterilization), 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.
Pharmaceutical Analysis:
Analytical quality control comprises the testing of raw materials, packaging materials, bulk solutions, in-process materials and finished product. Our personnel are trained in the state-of-the-art analytical techniques. The employed instruments are qualified according to current guidelines and the selected methods of analysis are validated according to international requirements.
Regulatory Affairs Service:
In parallel with the clinical phases we assist our customers in the preparation of the documents necessary for the international registration of their products. Vetter personnel with extensive knowledge about the Vetter systems and the FDA and EMEA requirements assume the technical-writing tasks. When preparing the dossier parts that are needed for registrations (EU/US-CTD Module 3, Drug Product Section), we approach the needs of our customers in a highly flexible manner. The long-term experience and expert competence of our staff assure an efficient and economic approval process.
Transfer to Vetter Commercial Manufacturing:
When the clinical phases have been completed, the staff of Vetter Development Services transfers the products to commercial production.
Dosage Forms:
Syringes, Cartridges and Vials
•Product Sheet: Vetter Development Service