FAQ

ACROBiosystems has built a strict quality control system. For quality control, we have strictly implemented a comprehensive quality control process from drug substance to finished products, which consists of 20+ advanced testing techniques, 30+ tests, 4 audits and 3 releases.

Click to view: Quality control process of ACROBiosystems

(1) DMF is the abbreviation of "Drug Master File". It is a complete set of documents including product chemistry, production and controls (CMC) information. The contents include general product information, and the information and data on manufacturing process, impurity research, stability, etc. It also includes core secrets related to the product, such as detailed process description, critical process parameters, complete material information, etc. There are two states of DMF: "A" = Active state, which indicates that the DMF has been assigned with a filing number/registration number/record number and is normally maintained and available. "I" = Inactive state, indicating that the DMF has been closed by the holder or FDA and is unavailable.

(2) Currently, there is no certificate but it will be published on the FDA website and accessible to all.

(3) Yes, ACROBiosystems achieved the first DMF filing of recombinant protein reagent in July 2020, and is the first company in the industry of which the recombinant protein has passed the DMF filing of FDA.

(4) The products of 33 catalog numbers have been submitted for DMF filing, and more products will continue to be submitted for DMF filing in the future.Click for more DMF filing details.

If you require IND/BLA application, please contact quality@acrobiosystems.com，to obtain a letter of authorization (LOA). In addition, ACROBiosystems expects to complete the DMF filing of all GMP products by mid-2022.

Product quality control is a comprehensive control system. The control strategies of ACROBiosystems include: control and inspection of raw materials; testing of intermediate products, semi-finished products and final products according to standardized SOPs. Thus, the product quality is ensured to be effectively controlled and guaranteed from beginning to end. Product release is conducted by qualified authorized personnel, and supplier audits are conducted as needed. In addition, the effectiveness of quality control is also monitored by monitoring product complaints and nonconforming products, corrective and preventive actions and plans, etc.