Novasep has announced that it is building a new synthesis laboratory and a kilo lab for its US facility. This extension will allow Novasep to offer both chemistry and purification services. It will enable Novasep to produce the initial kilogram scale batches of synthetic molecules that are needed for biological testing and preclinical trials.
Novasep’s investment is a direct response to increasing demand from US customers for closer proximity to Novasep’s contract manufacturing services that accelerate early stage development and ease production scale-up. The new laboratory will start operations in May 2016.
“The new US laboratory greatly enhances Novasep’s global offering for CMO services,” said Andrew Brennan, general manager of Novasep’s US operations. “Our unique skills and expertise in highly specialized chemical and purification technologies rank us among the leaders in these fields. US drug developers will benefit from our extended services that specifically target their needs.”
The new laboratory will be located at Novasep’s facility in Boothwyn (PA), 20 minutes from Philadelphia airport. This team has provided Novasep purification development services to North American customers for more than 15 years; including screening and process development derived from Novasep’s proprietary preparative chromatography technology.
“This US undertaking is part of our ‘Back to Basics’ strategy we have been implementing for more than two years now,” added Thierry Van Nieuwenhove, president of the Synthesis BU. “Novasep is adapting its CMO services to the US market where flexibility and proximity to our customers are required.”
Novasep will equip the US facility with reactors up to 50L in size. The 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 evaporation. In addition, it will be equipped with all required analytical tools for PR&D (Process Research and Development), including process safety testing capabilities.
Novasep is a global CMO offering a full range of cGMP development and manufacturing capabilities in Europe. Last year, it made a significant €10M ($11M) investment in a fully integrated Antibody Drug Conjugate (ADC) facility at its Le Mans site in France, thereby expanding its bioconjugation services.
The company continues to strengthen its proven track record in process development and technology transfer. All of Novasep’s commercial scale facilities have successfully passed FDA inspection in the last three years.