Asymchem, a global leader in contract development and manufacturing (CDMO) solutions, has announced its new OEB5 facility is now officially operational. Designed for the highest international safety standards and equipped with advanced technologies, the facility significantly enhances large-scale HPAPI manufacturing capabilities.
This 6,000 m², four-story plant equipped with a full range of synthesis reactors (5 L to 1,000 L) and supporting isolation and purification systems, it enables end-to-end high-potency compounds from gram to multi-kilogram scale, with an annual capacity exceeding 500 kg. Each unit operation is supported by advanced engineering controls and automation systems, ensuring completely enclosed processes while significantly reducing manual handling. With a containment performance target (CPT) of 1 ng/m³, the facility fully meets the strict standards of safety and regulatory compliance.
The facility supports global HPAPI production, including payload-linkers, small molecules and more, meeting multi-phase demands from toxicology studies to commercial-scale production. Furthermore, with the upcoming launch of the HPAPI R&D lab in Q3 this year, we will establish a fully integrated site that combines R&D, manufacturing, and analytical capabilities.
Jianbo Yang, Head of HP (High-Potency) Business Unit at Asymchem, commented, "The launch of our world-class HPAPI facility, built to meet the highest international standards, marks a significant milestone for Asymchem. We’re now even better positioned to deliver safe, efficient, and fully compliant solutions that help our global partners accelerate their path to market.” Asymchem will continue to deliver cGMP-compliant, safe, and efficient R&D and manufacturing services across the full drug lifecycle through leading technology and strict quality systems.
