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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The former formulation-development business of MDS Pharma Services seeks to build its niche in early-phase drug development.
Xcelience is a contract research organization (CRO) that is building its capabilities in preformulation, formulation, analytical, manufacturing, and packaging services. The company was formed in May 2006 as a management buyout from its former parent company, MDS Pharma Services (King of Prussia, PA). Xcelience recently announced an expansion of its facilities and equipment capabilities.
Xcelience was founded by current CEO Derek Hennecke and current Vice-President Randall Guthrie, both formerly with MDS Pharma Services and part of the management team that created Xcelience. Hennecke was vice-president and general manager, pharmaceutics and biopharmaceuticals of MDS Pharma Services from 2004â2006. He was responsible for the business and operations of MDS’s CRO formulation development, including capsule development, tablet formulation, modified-release tablets, suspensions, solutions, suppositories, creams, ointments, and gels. This business was spun off from MDS Pharma Services in 2006 and is now the basis of Xcelience. Prior to the launch of Xcelience, Guthrie led MDS Pharma Services and the legacy Phoenix International as vice-president of business development and vice-president of strategic development.
"Xcelience supports the drug-development process between drug discovery and Phase IIb," explains Guthrie. "We are focused on assisting our clients by accelerating their early drug development, which can include proof of concept, candidate optimization, preclinical dose preparation, and clinical supplies."
Roughly 90% of the company's business involves oral drug development, which includes solids, semisolids, and liquids. Xcelience also performs formulation development for topical creams and ointments. Filling of active pharmaceutical ingredients for capsules is one area of particular expertise for the company. Xcelience uses Capsugel's (Peapeck, NJ) "CFS1200" capsule-filling and sealing machine for liquid fills and Capsugel’s "Xcelodose 600" for solid fills.The CFS1200 can fill and seal two-piece capsules with liquid or semisolid formulations. The Xcelodose system is a precision powder microdoser and automated encapsulator with a fill range of 100 micrograms to greater than 100 milligrams. It allows the user to directly fill APIs into capsules (without excipients) at a rate of several hundred capsules per hour. The system is suited to producing formulations for use in clinical trials.
In January 2008, Xcelience enhanced its solid-fill capabilities with the purchase of "Xcelodose 600 S" precision powder micro-doser and automated encapsulator. The S model fills at speeds of over 600 capsules an hour at 50% greater throughput than its predecessor, the Xcelodose 600, according to Xcelience. The company expects to put the Xcelodose S in operation by May 2008.
Since its formation as a independent company, Xcelience has grown from 43 employees to almost 80. Based in Tampa, the company purchased a 24,000-ft2 building in Tampa in 2007 that will double its overall size to 50,000 ft2. Plans are to open the new facility in the third quarter of 2008. The facility will house additional good manufacturing practices (GMP) and non-GMP capabilities to support client needs.
Xcelience serves small biotechnology or virtual companies, mid-sized pharmaceutical companies, and large pharmaceutical companies. It supports the spectrum of companies from simplistic fee-for-service arrangements to more complex risk-sharing arrangements. "Companies outsource for a variety of reasons,"says Guthrie. "Whether it is overflow needs, specialized services, a lack of their own capabilities, or just parallel development plans, there is always an expectation of quality and understanding of the sponsor company's expectations in the outsourced relationship."