Customer proximity is important to accelerate early stage development and ease production scale up. For this reason Novasep has recently expanded its range of early phase process development and scale-up services for chemistry and purification out of its US headquarters in Boothwyn, PA, enabling production of the first kilograms of synthetic molecules for biological testing and preclinical trials. For more than 15 years this facility has been home to Novasep’s purification development services for North America, and offers screening & process development using Novasep’s proprietary preparative chromatography technology.
CAPACITIES AND CAPABILITIES
The US facility in Boothwyn, PA, is equipped with jacketed reactors ranging from 100mL to 50L in size and with a 35L filter dryer for isolation of Kg quantities of compound. The laboratory extension features all necessary equipment for standard and cryogenic chemistry. In terms of purification services, it provides North American customers with the complete portfolio of Novasep preparative chromatography technologies, such as HPLC (Hipersep®) and SFC (Supersep®). In addition, it has all the required analytical tools for Process Research and Development (HPLC, HPLC/MS, GC, GC Headspace, UPLC, UPLC/MS, etc…) including a calorimetric reactor for preliminary process safety testing.
OUR NEXT MISSION : TECHNOLOGY TRANSFER
By working with Novasep, LLC, our customers have access to all of our five chemical production plants which are regularly audited by the FDA and by local authorities, all of which have established a strong quality track record over the years. These facilities are closely connected and benefit from shared resources for Project Management or R&D for instance. In addition, the technology transfer will follow internal SOPs.
THE NOVASEP SYNTHESIS – TRICLINIC LABS STRATEGIC PARTNERSHIP
The newly formed alliance between Novasep and Triclinic Labs enables both parties to offer their customers a full API development service, ranging from first chemical synthesis to solid form optimization. Novasep’s services are extended to include solid form screening, selection, development, characterization and analytical method development.
EARLY STAGE SERVICES IN EUROPE
Novasep offers purification development services from its Pompey & Chasse-sur-Rhone facilities in France, including screening & process development using Novasep’s proprietary preparative chromatography technology.
The Chasse-sur-Rhone site boasts a cGMP kilo lab equipped with 30 L & 65 L glass-lined reactors & Hastelloy filter-dryer. The site specializes in combining synthesis and purification services offering a wide range of scale-up options for both batch and continuous (SMB) chromatography.
In addition, Novasep's Le Mans site in France supports the early phase development of HPAPIs & cytotoxics including Antibody Drug Conjugates (ADCs). The site is equipped with cGMP kilo labs and combines synthesis and HPLC chromatography of Band 4 compounds (Safebridge).