Altruist Biologics' Hangzhou ADC Facility Receives First Trilateral Provincial Regulatory Approval for Segmented Manufacturing
Key Insights
Altruist Biologics (search)' Hangzhou site becomes the first ADC facility in China to receive three provincial regulatory approvals for segmented production of antibody-drug conjugates (search).
The approval validates the company's unified quality system, strict risk assessment protocols, and compliance with regulatory requirements spanning development through commercialization.
The facility features single-use reactor systems with conjugation scales up to 500 L, high-containment systems with OEL capability of 5 ng/m³, and fully automated aseptic filling capabilities.
Altruist Biologics (search), a wholly owned subsidiary of Innovent Biologics (search) and a contract development and manufacturing organization (CDMO), announced on July 8, 2026, that its Hangzhou site has successfully passed a comprehensive inspection from three provincial regulatory bodies in China for the segmented production of antibody-drug conjugates (search) (ADCs). This marks the first instance of a trilateral regulatory approval for ADC segmented manufacturing in the country, representing a significant milestone for both the company and the broader biopharmaceutical manufacturing landscape.
Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics (search), emphasized the centrality of quality to the company's operations: "Quality is the foundation of everything we do at Altruist. Our integrated global quality system enables us to consistently deliver the highest standards of compliance, reliability, and operational excellence while supporting the evolving needs of our partners worldwide. As we continue to expand our global capabilities, we remain committed to accelerating the development and manufacture of innovative therapies that help bring life-changing medicines to patients around the world."
Facility Capabilities and Infrastructure
The Hangzhou site operates as a standalone ADC and AXC bioconjugation facility, designed to support the manufacture of various bioconjugates, including high-potency ADCs for both clinical and commercial supply across small- and large-scale production. The facility integrates laboratories dedicated to ADC process development, quality control, and Manufacturing Science and Technology (MSAT), enabling seamless progression from early development through to commercial manufacturing.
Key technical features include single-use reactor systems that currently support conjugation scales of up to 500 liters, with additional capacity of 1,000 to 5,000 liters currently under construction. The facility also houses a fully automated, isolator-based aseptic filling system equipped with two 7.5 m² and three 35 m² lyophilizers, providing flexibility for both liquid and lyophilized drug product formats.
Safety and Containment Standards
The Hangzhou site is purpose-built for the safe handling of high-potency active pharmaceutical ingredients (HPAPIs), incorporating stringent high-containment systems with an Occupational Exposure Limit (OEL) capability of 5 ng/m³. This specification ensures the highest standards of operator safety, environmental control, and regulatory compliance during ADC manufacturing, where cytotoxic payloads demand rigorous containment measures.
Track Record and Global Reach
Altruist Biologics (search) has successfully managed over 40 ADC and AXC projects, with ADC molecules spanning from pre-IND through Phase 3 and process performance qualification (PPQ). The company operates advanced cGMP facilities in both Suzhou and Hangzhou, with a total production capacity of 232,000 liters. Over more than a decade of bioprocessing expertise, Altruist has supported the commercialization of 18 drugs and completed over 2,000 commercial batches with a success rate exceeding 99.8%.
The company's regulatory track record includes 100 global regulatory filings with agencies including the FDA, EMA, NMPA, PMDA, TGA, and BPOM, as well as over 80 successful authority audits. With a workforce of more than 1,000 employees, including leading experts and scientists across all areas of biologics production and innovation, Altruist continues to expand its capabilities to meet growing global demand for ADC and bioconjugate manufacturing.