Cleanroom infrastructure, including filling units, were installed in May 2010.
The third cleanroom includes a filling line that supports larger quantities of single-chamber, pre-sterilised syringes.
The second cleanroom includes a semi-automated filling line that will support a range of packaging materials, including vials, syringes and cartridges.

Vetter Pharma’s new small-scale fill-finish facility is in Skokie, a suburb of Chicago. Located at the Illinois Science + Technology Park, it is Vetter’s first facility outside Germany. The facility is intended to bring Vetter closer to its core customer base, as two thirds of Phase I and Phase II drugs originate from the US. It will support projects from the pre-clinical stage up to Phase II.

Vetter’s facility began accepting projects at the end of April 2011. Nearly 60 highly skilled professionals have been employed at the facility, including some from Vetter’s operations in Germany.

In May 2010, Vetter entered into a partnership agreement with Sentry BioPharma Services, a supply chain management and clinical packaging service provider. Under the agreement, the filling of early stage and high value biopharmaceuticals will be carried out at the Vetter facility. Sentry, through its Indianapolis site, will undertake labelling, packaging and shipping of the clinical supplies.

Small-scale fill-finish facility

The facility is spread over an area of 24,000ft² at the 23-acre Illinois Science + Technology Park. The facility includes microbiology and chemical laboratories. Other functional areas have been specifically dedicated to qualification and validation, engineering, materials preparation, compounding, aseptic filling, visual inspection, quality assurance and supply chain.

Three cleanrooms have been installed, and all feature monitoring and laminar airflow equipment to reduce air turbulence. One is equipped with Bosch’s new MHI 2020 automated vial filler unit. Vetter is the first company to use the unit, which has been specifically designed for clinical stage trials.

The vial filler can handle liquid pharmaceuticals in small batches. It is equipped with multiple dosing systems, and can fill up to 10,000 liquid or 5,000 lyophilised vials per day without the need for retooling. An integrated checkweigher ensures consistent fill weight across the batch, making necessary adjustments wherever required.

“The facility will support Phase I, Phase IIa and and Phase IIb projects.”

The second cleanroom features a semi-automated filling line that can support a range of packaging materials, including vials, syringes and cartridges. Although designed for liquid fills, the unit also supports the filling of non-cGMP lyophilised units. Between 500 and 600 items can be filled per batch.

The third cleanroom includes a filling line that supports larger quantities of single-chamber, pre-sterilised syringes.

Vetter pharmaceuticals production

The new facility will support projects that are in Phase I, Phase IIa and Phase IIb stages. Small quantities of products will be filled, if required, for early studies. Phase III projects will be taken care of at Vetter’s German facilities for large-scale production.

The facility will carry out the automatic filling of liquid and lyophilised vials that substantially minimises loss of API. Liquid and lyophilised vials are a type of injection system used by nearly 90% of initial-stage parenteral candidates. Semi-automatic filling of cartridges, dual-chamber systems and syringes will also be undertaken at the facility.

Illinois Science + Technology Park

Established in 1941, the Illinois Science + Technology Park is a large corporate research campus with approximately 660,000ft² of leasable space. Formerly owned by Pfizer, the campus is only 20 minutes from the O’Hare domestic and international airport and is equipped with established infrastructure. Around 70,000 skilled professionals work in the park.

“Vetter’s facility is situated in a 130,000ft², four-storey building.”

Facilities at the campus include chemistry and genomics laboratories, GMP manufacturing suites, cleanrooms, NMR suites, research and toxicology labs, conference facilities, and administrative offices. In addition to Vetter, clients at the campus include Midwest BioResearch, NanoInk, Nanotope, NanoIntegris, Fisher Scientific and Global Pharma Device Solutions.

Within the campus, Vetter’s facility is situated at 8025 Lamon Avenue, in a 130,000ft², four-storey building constructed in 1984. It features clinical development GMP suites, cleanrooms and NMR suites. Cleanroom facilities at the building include a 10,600ft² GMP R&D facility, a 9,800ft² GMP solid dosage pilot plant, a 5,800ft² stability research laboratory and a 3,200ft² microbiology sterile research suite.