Vetter Pharma International - Aseptically Pre-Filled Drug-Delivery Systems

Vetter is an independent international specialist in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with a broad array of substances, including monoclonal antibodies, peptides, interferons and vaccines.

Headquartered in Ravensburg, Germany, Vetter provides support for pharmaceutical and biotech clients from preclinical development through regulatory approval and global market supply. Vetter's new Chicago facility, an expansion of Vetter Development Service, supports early-stage products.

Vetter Development Service

It is essential that a substance and its delivery system are optimally compatible. Biotechnology drugs, in particular, contain highly sensitive active ingredients that can interact with the drug-delivery system. Other considerations include a drug's sensitivity to oxygen or to the silicone that coats the inside of a syringe to lubricate the plunger.

Vetter Development Service specialises in taking complex compounds from preclinical development through market launch. In close collaboration with its customers, Vetter selects:

• The drug-delivery system that matches the requirements of the drug in development
• Appropriate processes, such as lyophilisation (freeze-drying) for unstable products
• Suitable transport magazines and secondary packaging components
• Special inspection devices and methods

During manufacture, state-of-the-art technology and methods minimise loss of active ingredient. To help prevent surprises at market production, commercial manufacturing processes are replicated in early-stage laboratories. At phase III, products are transferred to Vetter Commercial Manufacturing for large-scale filling.

Vetter Development Service provides:

• Primary and secondary packaging development
• Process development
• Clinical manufacturing
• Pharmaceutical analysis and stability storage
• Regulatory affairs services
• Transfer to Vetter Commercial Manufacturing

Vetter Commercial Manufacturing

Vetter Commercial Manufacturing serves a global customer base, including the world's leading pharmaceutical and biotech companies. The company fills products in accordance with international standards and handles the full scope of production, from aseptic filling to final packaging.

Vetter's manufacturing facilities are highly automated and use innovative technologies. Vetter is a leader in restricted access barrier systems (RABS) technology, used in state-of-the-art cleanrooms to minimise risk of contamination. RABS combines the functionality and stability of an insulator with the flexibility of a classical cleanroom. Laminar airflows establish barriers between staff and machinery. All devices in direct contact with product are sterilised. Sterile gloves are integrated into the filling-machine cover, to ensure that man, machine and environment remain separated.

Vetter Commercial Manufacturing provides:

• Fill and finish
• Packaging service
• Pharmaceutical analysis
• Regulatory affairs services

Vetter Solutions

Vetter Solutions develops proprietary, patented innovations. The Vetter Lyo-Ject® dual-chamber syringe was designed especially for pharmaceuticals preserved by freeze-drying. One chamber contains the lyophilised drug; the other, the solution. The drug is reconstituted immediately before application. This all-in-one concept enables longer storage periods and a more user-friendly product, as well as more accurate dosing. Vetter's V-LK® dual-chamber cartridge enables multiple dosages of lyophilised drug, and is used in pen and auto-injection systems.

The V-OVS® tamper-evident closure system promotes patient safety and can be installed on conventional prefilled syringes. For syringes with stacked needles, Vetter's patented tamper-evident closure system with needle protection (V-OVS NS®) provides added security.

Vetter Solutions includes:

• Dual-chamber technology: Vetter Lyo-Ject®, V-LK®
• Anti-counterfeiting measures: V-OVS®, V-OVS NS®

About Vetter

Vetter works with the world's leading pharmaceutical and biotech companies, and employs 2,300 staff across Europe and the US. The innovator of the Vetter Lyo-Ject® dual-chamber syringe and V-LK® cartridge, the company holds nearly 140 patents and is a leader in the use of RABS technology in cleanrooms. Approved as a foreign manufacturer by the government of Japan, Vetter's global regulatory experience includes numerous customer product approvals by the FDA, EMA and other authorities.

Over its more than 25-year history in aseptic filling, Vetter has won many awards for its facilities and operations, including the 2009 Axia Award for customer relationship management and the 2010 SAP EMEA Quality Award, silver medal, for the implementation of a company-wide planning software system.