GMP products

Especially in the pre-clinical and clinical phases, we understand that the safety and quality of raw and ancillary materials are of the utmost importance. Our recombinant proteins are manufactured and tested in accordance to the relevant USFDA GMP (Good Manufacutring Practice) guidelines under an ISO9001:2015 and ISO 13485:2016 quality management system with animal-origin free (AOF) materials. To ensure our products do not impact your final product, we take a step further by implementing stricter quality controls that include mycoplasma, viral, and in vivo toxicity tests.

The successful translation of your cell therapy products hinges upon material-selection decisions that impact manufacturing. Raw materials chosen in the early stages need to conform to all regulatory criteria when entering clinical trials and later stages. At ACROBiosystems, we ensure that our GMP products follow regulatory standards from internationally recognized bodies including ISO, US and European Pharmacopeias. Furthermore, we take pride in our comprehensive and strict quality management system to produce our products. Especially in cell therapy products where safety matters, we uphold our strict expectations to ensure the ancillary materials we provide to you do not impact your final product.

For our GMP grade products, ACROBiosystems offers comprehensive documentation (drug master files) including detailed quality inspection, analytical method verification reports, and many others. 

Strict quality control standars

 > Purity / Structural verification by SDS-PAGE & SEC-MALS
 > Low Endotoxin levels
 > Residual Host Cell DNA content
 > Residual Host Cell Protein content
 > Biological Activity, Sterility, Residue testing
 > Mycoplasma testing
 > In vivo Safety and in vitro virus assays
 > Comprehensive stability data support (accelerated, freeze-thaw, long-term, shipping stability verification)
 > Batch-to-batch consistency
 > Microbial testing and more.