LYON, France—Responding to increasing demand from U.S. customers for closer proximity to Novasep’s contract manufacturing organization (CMO) services that accelerate early-stage development and ease production scale-up, the global provider of cost-effective and sustainable manufacturing solutions for life-sciences molecules and fine chemicals is building a new synthesis laboratory and a kilo lab for its U.S. facility in Boothwyn, Pa. The company’s new laboratory will begin its operations in May 2016.
Novasep, which provides a full range of contract manufacturing, purification and development services for the life-sciences industry, has a wide range of capabilities on multiple sites. According to the company, this extension will enable Novasep to offer both chemistry and purification services, as well as to produce the initial kilogram scale batches of synthetic molecules that are required for biological testing and preclinical trials.
As Andrew Brennan, general manager of Novasep’s U.S. operations, explained, “The new U.S. laboratory greatly enhances Novasep’s global offering for CMO services. Our unique skills and expertise in highly specialized chemical and purification technologies rank us among the leaders in these fields. U.S. drug developers will benefit from our extended services that specifically target their needs.”
The Boothwyn facility, which is located 20 minutes from the Philadelphia airport, has provided Novasep purification development services to North American customers for more than 15 years. Founded in 1998, the facility has offered screening and process development derived from Novasep’s proprietary preparative chromatography technology.
“This facility represents the company’s entire portfolio in North America, including the USA, Canada and Mexico,” Brennan said. “Novasep has on-site engineering capabilities for the manufacture of purification systems according to U.S. regulations and offers commissioning and customer service in North America.”
According to Thierry Van Nieuwenhove, president of the Novasep Synthesis Business Unit, “This U.S. undertaking is part of our ‘Back to Basics’ strategy we have been implementing for more than two years now. Novasep is adapting its CMO services to the U.S. market where flexibility and proximity to our customers are required.”
Novasep will equip the U.S. facility with reactors as large as 50 liters. The company’s new laboratory will feature cryogenic capacities as well as standard chemistry. In terms of purification, it will provide North American customers with the complete portfolio of Novasep preparative chromatography processes, such as HPLC (Hipersep), SFC (Supersep) and state-of-the-art evaporation. In addition, it will be equipped with all required analytical tools for process research and development, including process safety testing capabilities.
According to the company’s website, “Novasep brings innovative solutions to complex challenges within the life-science industries for the production of synthetic molecules and biomolecules. Our offering helps our customers to enhance product quality, reduce production costs and shorten time to market.” To accomplish that, the company develops manufacturing solutions, provides custom manufacturing services (outsourcing solutions) and sells purification processes (in-sourcing solutions).
Novasep offers preparative and process chromatography units and services, which include high-pressure batch chromatography, high- and low-pressure continuous chromatography, supercritical fluid chromatography, modeling software and process development services. Also available are purification services for pharmaceuticals, fine chemicals and cosmetic and food ingredients, including synthetic intermediates and active pharmaceutical ingredients, chiral separations, isolation of molecules from complex reaction mixtures, purification of synthetic peptides and highly potent compounds and purification of natural extracts.
Last year, Novasep invested $11 million in a fully integrated antibody-drug conjugate facility at its Le Mans site in France, thereby expanding its bioconjugation services. A global CMO offering a full range of cGMP development and manufacturing capabilities in Europe, the company is attempting to strengthen its proven track record in process development and technology transfer. All of Novasep’s manufacturing sites have successfully undergone preapproval inspections by the U.S. Food and Drug Administration over the last three years.