Leave message
Can’t find what you’re looking for?
Fill out this form to inquire about our custom protein services!
Inquire about our Custom Services >>
A-Z
> Quality Control Systems for GMP Products 
Superior quality, global standards. We strictly adhere to GMP regulations to ensure that each batch of our products undergoes comprehensive and rigorous quality control, meeting the highest international standards. Key analytical methods such as sterility and endotoxin testing are strictly conducted in accordance with USP/EP standards to ensure their applicability and accuracy. For Non-pharmaceutical methods, we perform thorough method validation to ensure the accuracy and reliability of test results. Additionally, our quality control system is equipped with audit trail functionality to ensure data integrity and traceability, fully complying with the requirements of international regulatory bodies such as the FDA.
Through stringent batch-to-batch consistency control and full-process quality monitoring, we ensure that each batch of our products possesses exceptional stability and reliability, meeting the stringent demands of global customers. Choosing our GMP products is choosing compliance, reliability, and high-quality assurance.
Sterility Test
USP<71>
The sterility of raw materials used in CGT g product manufacturing is critical, because most CGT drug products are not terminally sterilized. Therefore, we have comprehensively introduced the sterile assurance strategy for key materials in CGT production. Click to read more.
Endotoxin Test
USP<85>
Maintaining a low endotoxin level in biologics is essential for ensuring patient safety and preventing endotoxin-related diseases. Several methods are acceptable: qualitative gel clot and chromogenic LAL-based methods. However, if there are any inconsistent or conflicting results, the gel clot result is deemed authoritative.。
Mycoplasma Test
USP<63>
Mycoplasma is a common contaminant in cell and tissue cultures. ACROBiosystems uses commercially validated rapid detection kits combined with pharmacopoeia culture or indicator cell culture methods for mycoplasma testing and release of products to better meet safety requirements
Residual Test
USP<509, 1132="">
Comprehensive production process residue testing, including HCD, HCP, Protein A residue, etc., ensures that all process impurities are thoroughly removed, ensuring the safety of cell therapy from the source. We have also conducted comprehensive method validation for various residual detection and analysis methods based on pharmacopoeia and ICH guidelines to ensure accurate and reliable analysis and testing results.
Other Characteristics
In addition to various key quality attributes, we have conducted strict quality control in accordance with the pharmacopoeia drug quality requirements in terms of purity, impurities, content, appearance, clarity, visible foreign matter, loading capacity, and other aspects to ensure batch to batch consistency.
Conduct comprehensive validation of the analytical methods used in GMP products in accordance with the requirements of USP<1225>VALIDATION OF COMPENDIAL PROCESS and ICH Q2 (R1) Validation of Analytical Procedures Text and Methodology.
Learn more about our product stability
assessment and interpretation methods.
Stability testing is the basis of evaluating a product’s shelf-life. To evaluate stability and consistency within a viable timeframe, the accelerated stability testing method, based on the Arrhenius equation, is a widely recognized strategy, and numerous studies in recent years have demonstrated its applicability and accuracy.
A well-established, stringent, and professional quality control system can be what makes-or-breaks any therapeutic approval process and should reference pharmacopeia standards such as USP. ACROBiosystems continuously refines our GMP quality management system to help provide reliable support when it comes to raw materials for cell and gene therapies.
This web search service is supported by Google Inc.
