Novasep Expands It’s North American Facility: Adding A Synthesis Laboratory and Kilo Lab

Featured Image: Moon over the Saône near Lyon, France.. The river Saône rises at Vioménil at the foot of the cliff of the Faucilles in the Vosges at an altitude of 392 m, and flows into the Rhône at Lyon at an altitude of 158 m. Its length is 480 km. Its largest tributary is the Doubs; upstream of receiving the Doubs at Verdun-sur-le-Doubs in Saône-et-Loire, the Saône is called the "Petite Saône" (lesser Saône), which reflects the large contribution of the Doubs to the Saône. In fact the Doubs' mean annual flow rate is slightly stronger than that of the Petite Saône (175 vs. 160 m³/s); some thus assert that it is in fact the Saône that flows into the Doubs. Nonetheless the Saône has a substantially larger watershed than the Doubs, at 11500 vs. 7500 km². At 30,000 km² the Saône has the largest watershed of any French river which does not flow directly into the sea, covering approximately 1/18 of metropolitan France. In pre-Roman times the river's name was "Arar", a doubling of the Indo-European root ar (water). According to Caesar's Gallic Wars this doubling reflected the idea that it was difficult to identify the direction of the river due to its slow rate of flow. Its current name came from a sacred spring, Sauc-Onna, located at Chalon, which was used by Roman legionnaries to refer to the entire river. Courtesy: © Dimitry B - London. Creative Commons Used with permission.

Lyon (France) -based Novasep, a leading supplier of services and technologies for the life sciences industry is building a new synthesis laboratory and a kilo lab for its North American facility. This extension allows the company to offer both chemistry and purification services and enables Novasep to produce the initial kilogram scale batches of synthetic molecules that are needed for biological testing and preclinical trials.

The company’s investment is a direct response to increasing demand from North American customers for closer proximity to Novasep’s contract manufacturing services that accelerate early stage development and ease production scale-up. Operations in are expected to start in May 2016.

Global offering
“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.”

ADC Bio
MabPlex
Lonza
 

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.

“Back to Basics”
“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.“

The new laboratory, which will be equiped with reactors up to 50L in size, 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 PR&D (Process Research and Development), including process safety testing capabilities.

Antibody-drug Conjugates
In Europe, Novasep offers a full range of cGMP development and manufacturing capabilities. In 2016, the company made a  significant €10M (US $ 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.