The growth in biological-based drugs is creating opportunities for contract manufacturing organizations (CMOs) involved in sterile manufacturing. Vetter Pharma-Fertigung GmbH & Co KG (Ravensburg, Germany) is one such company, and it is investing in its production facilities.

Vetter invests $100 million in new facility

Vetter Pharma provides contract manufacturing and aseptic filling of prefilled injection devices for the parenteral drug market. The company recently completed a three-year, $100-million investment for a new 16,000-m² facility near its headquarters in Ravensburg, Germany. The new facility increases Vetter's production capacity for prefilled injection systems by roughly 30% to 400 million units per year. The new facility has a capacity of approximately 90 million units per year. The new facility supports dosage-form studies in the early phases of product development, material for clinical studies, and full commercial manufacturing.

Preliminary operations at Vetter's new facility began in October 2006, and full production began in January 2007. The facility has two filling lines for liquid and lyophilized injectable drugs in dual-chamber syringes, single- and dual-chamber cartridges, and vials. In addition to 2920 m² of production floor space, the new facility includes a separate building with steam production and an uninterruptible power supply. The facility also will include laboratories for chemical and microbiological analysis in the near future.

"A key feature of the facility is the high degree of automation," says Thomas Otto, one of the managing directors of Vetter. "Automation was planned throughout the building, from door openers to the use of the brand new restricted access barrier system on the filling lines."

The filling lines are arranged to allow for modularity and flexibility. "Thanks to the modular structure of the site, two additional filling lines can be added while production is in progress on our existing filling lines," says Otto. "If required, this expansion can be implemented at very short notice." The plans take into account the space requirements for the two additional lines. The supply of resources is basically already in place, he adds.

Investment builds on position in dual-chamber syringes

Vetter has a strong patent position in dual-chamber syringes. Its key product is the "Vetter Lyo-Ject" syringe. In the dual-chamber syringe, one chamber is filled with a lyophilized product, and the other is filled with a diluent. When the plunger is pressed, the diluent and lyophilized product are mixed and can be injected.

While single chamber systems are used for liquid substances, a dual-chamber system is especially well-adapted for two-drug components (lyophilzed-liquid or liquid-liquid) that must be kept separate in the syringe or cartridge until they are used. Since both drug components are already inside the syringe or cartridge, less active substance is lost when administering the drug. This can save as much as 10% of the active substance, in comparison with the application of conventional injection systems, according to the company.

"As the growth in the overall pharmaceutical market is predominantly from new biotechnology products, the relevance of the Vetter Lyo-Ject syringe becomes obvious," says Otto. "Most biotechnology drugs can only be stable in a lyophilized form."

Vetter plans new packaging facility.

In addition to the new facility, Vetter has three other similar facilities in and around Ravensburg, including two aseptic-filling facilities and one final-packaging facility. The filling facilities can be used as backup systems.

Close to the new Ravensburg South production facility, Vetter has started building a new facility for secondary packaging. Secondary packaging involves the final packaging of the application system in blister packages and cardboard boxes. The 19,000-m² facility will be ready for production at the end of next year.

"With our new facility, we will be able to meet the most stringent international packaging standards," says Otto. The expansion is driven by increased customer demand in the growing market for homecare applications, which includes pen- and autoinjectors, and to meet increased adoption of safety systems for needlestick prevention.

Vetter targets early-phase development

Overall, Vetter manufactures 18 different client products that have been approved by the US Food and Drug Administration. In addition to providing commercial manufacturing, the company offers early drug-development services to meet growing demand from that segment.

"Currently, the pharmaceutical market is strongly influenced by globalization as well as stricter worldwide regulatory demands and growing competitiveness," says Otto. "This situation will persist for the foreseeable future. In this context, reducing the time needed to introduce a new drug to the market is becoming a major success factor for pharmaceutical and biotech companies around the world owing to the constant rise in development costs."

As a result, there is a need for contract manufacturers to bridge the phase between formulation and filling, provide the aseptic filling itself, and for packaging sensitive and complex active substances. To fill that need, Vetter Development Service (VDS) offers services to pharmaceutical manufacturers seeking to develop and launch parenteral drugs. Through VDS, Vetter provides services in the preclinical phase in process development and in clinical production. Support services include pharmaceutical analysis, regulatory affairs, and the development of primary packaging supplies.

References

1. M. Rios and B. Harrison, "Big Shot: Developments in Prefilled Syringes" Pharm. Technol. 31 (3), 50–60, 2007.