Vetter (Ravensburg, Germany) is developing fill-finish capacity at a new facility in Skokie, IL that will include three manufacturing clean rooms and state-of-the-art microbiological and chemical laboratories. An expansion of Vetter Development Service, the 24,000 sq ft facility will be operational by the beginning of the fourth quarter 2010, says Vetter managing director Thomas Otto.
“We will initially focus on early-stage products from preclinical through phase IIb, after which we will scale up and transfer products to our facilities for phase III filling and market production, Otto says.
“To help ensure a seamless transition to commercial manufacture, we’re replicating commercial processes at our early-stage (Skokie) site,” he adds.
One clean room will include a filling line for semi-automated, small-scale filling of vials, syringes, and cartridges. Filling operations in a second clean room are planned for pre-sterilizied syringes. A third clean room will feature the MHI 2020 automated vial filler from Bosch Packaging Technology (New Richmond, WI). The unit can be used for filling liquid vials from 10 to 10,000 pieces per batch and for lyophilized vials from 500 to 5,000 pieces per batch, Otto says.
“Vetter is the first company to use the new Bosch system, designed specifically for clinical-stage, high-value pharmaceuticals. The Bosch filler uses all disposable drug-contact components (which) eliminates the need for cleaning validation and thus supports time-to-market.
“It’s a compact machine with minimum tubing lengths, which increases API yield,” Otto says. “And it includes a 100% check-weight system. That’s important, because if the amount of drug in a vial is inaccurate, that may affect the outcome of a clinical study, especially in small, early-stage trials,” Otto adds.
For final assembly and packaging of prefilled injection systems, Vetter rounded out a complete service offering in parenteral packaging with last year’s launch of a Vetter Secondary Packaging facility in Ravensburg. The facility features a fully automated production line that automates processes including labeling, plunger rod insertion, packing in boxes, and the transport between stations. The line allows packaging twice the number of injection systems in half the time required before, Vetter says.