Vetter Pharma, a contract development and manufacturing organization (CDMO) that specializes in aseptic filling, recently doubled its capacities for performing visual inspection and In-Process Control at its facility in the Chicago suburbs. The company has also taken the initiative of an additional staff shift for daily clinical manufacturing operations.
The facility in Skokie, Ill. is part of Illinois Science + Technology Park, a 23-acre property first developed in 2005 and currently home to over 20 different companies. “Illinois is considered a ´hot spot´ in biotechnology, and that was important for Vetter,” says Michael Rosen, former Senior Vice President of New Business Development at the ISTP.
Vetter moved into a structure that had been empty since 2003, so retrofitting needed to be done in order to prep the facility for materials preparation, compounding, and aseptic filling of injectables. The site became fully operational by October 2011.
New microbiology and chemical analysis labs were added for performing functions such as incoming compound-specific testing and API concentration testing. Over the next two years, specialized filling equipment was housed in the three Class 100/10,000 area cleanrooms constructed to handle the clinical batches being produced.
One cleanroom hosts a flexible semiautomated filling unit capable of filling a variety of packaging materials such as syringes, cartridges, and vials with a capacity of up to 500 units per batch. A second cleanroom contains an automated vial filler (which Vetter says is the first of its kind), designed especially for early clinical-stage, high-value biopharmaceuticals capable of running up to 10,000 liquid or 6,000 lyophilized vials per batch. By the end of 2014 a third cleanroom was added to accommodate the fully automated filling of syringes. All filling units are integrated in a restricted access barrier system (RABS) in order to mitigate the risk of contamination by minimizing human contact with products during manufacture.
The Skokie facility has expanded its on-site offerings by giving customers the option to obtain secondary packaging services for small batches of frozen drug products such as vial labeling, cartoning, and carton labeling. A long-term collaboration with Sentry BioPharma Services, a provider of cGMP clinical packaging solutions and supply chain management, supports a streamlined path from filling to clinic.
The German-headquartered company deals with complex compounds, including mAbs, peptides, proteins, and oligonucleotides. Its 30,000 sq. ft. complex in the Chicago area features three state-of-the-art clinical manufacturing cleanrooms, flexible cGMP filling from preclinical to phase II for all common drug-delivery systems, and an on-site microbiology and chemical analysis lab.