Novasep Opens New Bioconjugation Unit in France

On Feb. 23, 2017, Novasep announced the opening of its new €11-million (approximately $11.64 million) bioconjugation unit in the company’s Le Mans site in France. The 2000m² facility includes two flexible good manufacturing practice (GMP) production suites equipped with 10L to 400L vessels to support both clinical and commercial manufacturing of antibody-drug conjugates. The stand-alone facility is purpose-built and offers R&D services, quality control, and scale-up laboratories.

“Our team has a long experience in applying DoE to chemical synthesis and bioprocessing and efficiently develop conjugation, and purification steps on a wide range of ADC platforms,” said Rachel de Luca, general manager of Le Mans site in a statement. “Furthermore, the site has established good manufacturing practices meeting the Quality and SHE standards applied to the production of anti-cancer compounds, confirmed by a long track of successful FDA inspections.”

Source: Novasep