Select Language
Free Registration
home

Preguntas frecuentes

1. What are the quality controls before product release?

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

2. What is DMF? Is there an approval certificate for DMF archiving? Has ACROBiosystems applied for the DMF filing of its products with FDA? What are the products submitted for DMF filing?

(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.

3. How does ACROBiosystems ensure product quality?

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.

4. What is the difference between GMP and Premium grades?

Premium Grade GMP Grade
Application Research and Development; Preclinical research and transition into clinical phases. Designed to meet clinical phase requirements and bolster your IND application to various regulatory bodies. v
Quality System ISO 9001 and 13485 Quality Management System ISO 9001 and 13485 Quality Management System (R&D stage) including GMP Quality Management System (Production stage)
Production ISO certified Workshop GMP grade workshop certified by third-party audits
Transient, stable cell lines Stable cell lines (Comprehensive external inspections)
Mostly animal-origin free materials Animal-origin free materials
Pharmaceutical-grade materials Pharmaceutical-grade materials
Strict secondary sterilization filtration Strict secondary sterilization filtration
Laminar flow cleanroom with manual fill finish B+A grade cleanrooms with automated fill finish
No specific virus removal or inactivation process Specific virus removal / inactivation process (nanofiltration + low pH)
Quality Control Sterility / Mycoplasma testing Sterility / Mycoplasma testing
Endotoxin control and detection Endotoxin control and detection
Validated key production equipment and analytical instruments Strict verification, auditing, and tracking of all equipment and methods.
Process-related impurity testing (DNA, HCP, Residue) Process-related impurity testing (DNA, HCP, Residue)
No additional quality control tests Comprehensive virus residue testing, animal in vivo safety experiments
Documentation Minimum documentation and certifications Comprehensive regulatory support documentation
DMF files (Few products) DMF files (All products)

If a Supplier Survey or Quality Statement is required, please click the buttoncontact us.

quality@acrobiosystems.com