Services that span the entire manufacturing process
As a full-service CDMO, Vetter provides complete aseptic fill and finish services for parenteral drug manufacturing, including liquid and lyophilized products in vials, syringes, and cartridges. Vetter experts can support you every step of the way, from development through packaging.
We offer manufacturing services for both clinical and commercial drug products, with the quality it takes to get you from clinical trials to market.
Process design and development
Smooth transfer is the goal of the transition from clinical-stage to commercial manufacturing. Vetter’s process design expertise helps develop processes that are scalable, reproducible, and flexible, helping to ensure a streamlined path to commercial production and on to market.
Our scale-up from the lab to commercial production uses a Quality by Design approach. We also offer expertise in lyophilization scale-up, commercial scale process, formal GMP validation, stability batches, and regulatory support at each step.
Lyophilization can help overcome many of the stability challenges associated with complex, sensitive molecules, resulting in a longer shelf life for the product. We fill lyophilized products in both vials and dual-chamber injection systems, and we can even work with you to develop a highly efficient lyophilization cycle.
We operate a 100% visual inspection process in which each final product is inspected and passes only when it meets the highest standards. We offer both manual and automated visual inspections and can customize our service to meet your product’s specific requirements, including customer-specific quality (CSQ) and visual inspection for the Japanese market.
We’ll help you select both primary and secondary packaging from a broad range of platform and specialized technologies. We’ll also provide customized packaging development, assembly, packaging and serialization, and aggregation services. Our packaging and filling operations comply with cGMP guidelines for the United States, Europe, and Japan.
Storage, logistics, and supply chain management
With extensive expertise in storing, packaging, and worldwide cold chain shipment, Vetter offers comprehensive support for compliance management, import/export customs management, transportation, and logistics. Our state-of-the-art storage facility features a high-bay, climate-controlled warehouse for cold-storage and room-temperature products, plus freezer storage capacity for frozen active ingredients.
Global regulatory support
Vetter provides expert documentation and consultation services throughout all phases of regulatory submission and post-approval. We offer in-depth knowledge of global requirements, including FDA, EMA, and PMDA (Japan).