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The company opened a new bioconjugation unit to support the clinical and commercial manufacturing of ADCs.
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.”