Novasep gains SafeBridge certification at Le Mans HPAPI plant
Novasep\'s site in Le Mans, France, which manufactures highly potent active pharmaceutical Ingredients (HPAPIs), has received potent compound safety certification from SafeBridge Consultants.
Novasep's site in Le Mans, France, which manufactures highly potent active pharmaceutical Ingredients (HPAPIs), has received potent compound safety certification from SafeBridge Consultants.
The certification programme verifies the active pharmaceutical ingredient and purification technology producer's performance in all aspects of its HPAI production.
California-based SafeBridge conducted a 60-element review of procedures at the Le Mans site. Novasep has met industry standards for the safe handling of HPAPIs in its r&d laboratories, kilolabs, a manufacturing scale synthesis area and associated quality control laboratories.
"The SafeBridge certification demonstrates the expertise and continued commitment of Novasep for more than 15 years at its Le Mans site in the safe handling of highly potent compounds," says Rene de Vaumas, head of the Novasep synthesis business unit.
"In Le Mans, Novasep offers a unique combination of total synthesis, extraction, semi-synthesis and chromatographic purification for laboratory to commercial scale manufacturing of a broad range of HPAIs, including cytotoxics."
In addition to the potent compound certification, Novasep has integrated facilities and expertise for monoclonal antibody production following the acquisition in July of Belgian contract manufacturer Henogen. Novasep is now able to provide manufacturing for antibody drug conjugates (ADCs) from early development to commercial scale.
ADCs, of which many incorporate cytotoxic compounds, represent the biggest r&d pipeline of the pharmaceutical industry, with more than 1,000 products currently in clinical trials, the company says.