Axplora’s Chasse-sur-Rhône Site Clears Ninth ANSM Inspection

• Axplora’s Chasse-sur-Rhône CDMO facility in France passed its February 2025 ANSM inspection with no critical remarks or 483 observations.

• This marks the ninth successful inspection since 2003, reaffirming Axplora’s compliance with cGMP standards.

Axplora, a global provider of small molecule and antibody-drug conjugate (ADC) manufacturing, has announced that its Chasse-sur-Rhône CDMO site in France successfully passed its latest inspection by the French National Agency for Medicines and Health Products Safety (ANSM). The inspection, conducted in February 2025, resulted in no critical remarks or Form 483 observations, confirming the site’s full compliance with current Good Manufacturing Practices (cGMP).

This inspection represents the ninth successful regulatory review of the Chasse-sur-Rhône site since 2003. The facility is a key contributor to Axplora’s European contract manufacturing network, which comprises five sites with a 100% regulatory inspection success rate.

“Our commitment to quality runs through every aspect of our operations,” said Sébastien Bosc, Head of Quality Assurance at Chasse-sur-Rhône. “The outcome of this inspection reflects the strength of our systems and affirms the continuous investment and improvement efforts we make to meet and surpass regulatory standards.”

With over 30 clinical and commercial small molecule projects, the Chasse-sur-Rhône site provides end-to-end support for pharmaceutical innovators, from early development to commercial supply. The facility supports scalability and supply chain flexibility as part of Axplora’s integrated CDMO offering.

“This achievement is the result of our team’s quality, safety, and operational excellence mindset, all delivered with reliability, speed, and efficiency,” said Daniel Lasanow, Site Director at Chasse-sur-Rhône.