Quality Overview

This is one of our strategic decisions to ensure that the quality of products and services is guaranteed through a third-party audited, efficient, and standardized system. Through this approach, we were able to systematically standardize the entire production process of our products including recombinant proteins, antibodies, enzymes, cytokines, kits, and other products. A clear organizational structure and department functions are also established, specifying the relevant responsibilities and authorities of each position and necessary interactions. This is all implemented to ensure that our quality policy and objectives are implemented and achieved as expected.

By adopting the PDCA cycle and risk-based thinking, we are able to proactively respond to market competition，and are continuously striving to improve our overall efficiency on the basis of understanding the needs and expectations of interested parties, so as to improve customer satisfaction.

Based on our quality policy to ‘First focus on customer needs and applicable statutory and regulatory requirements to be an important and valued partner in the field of targeted therapies’, ACROBiosystems group is willing to cooperate with customers and suppliers to emphasize a collaborative environment for therapy development. Regarding quality controls, we have strictly implemented a comprehensive quality control process starting from drug substance to finished products, which includes 20+ advanced testing techniques, 30+ tests, 4 audits and 3 releases .

We launched GMP-grade products in early 2022, including cytokines, antibodies, enzymes, and magnetic beads for ex vivo cell culturing. These products are not only produced under a pharmaceutical-grade manufacturing plant, but are also designed and controlled under relevant domestic and international CGT regulations. Our products are produced under five interconnecting systems: material system, manufacturing system, facility/equipment system, packaging/labeling system, and laboratory quality control system. which comprehensively elaborates on the "true GMP ".