Validated method according to ICH Q2(R1) for the detection and quantification of process residual PEIpro®, PEIpro®-HQ and PEIpro®-GMP in cell and gene therapy products
Proprietary highly sensitive analytical HPLC/UV
Regulatory guidelines for the production of ATMPs (Advanced therapeutic medicinal products) indicate that residual levels of raw materials used in the manufacturing process should be assessed as well as the significance of the residual level detected. This means that manufacturers should ideally determine how much of each critical raw material is still present, if any, in the final drug product. The importance of such an analysis is to make sure that the manufacturing process ensures the production of an ATMP that is reproducibly safe for patient administration.
Schematic representation of key steps in viral vector manufacturing for ATMP production. PEIpro® transfection reagents (PEIpro®, PEIpro®-HQ and PEIpro®-GMP) are critical raw materials used to transfect viral vector plasmids into cells during the upsteam process.
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We offer a comprehensive strategy to support viral vector manufacturers in their manufacturing process. In addition to extensive control testing performed on PEIpro® transfection reagents (PEIpro®, PEIpro®-HQ, PEIpro®-GMP) at each step of their manufacturing process, we have developed a test for residual PEIpro® measurement in ATMPs. This method is a highly accurate and sensitive HPLC/UV-based method validated in compliance with ICH Q2(R1) guidelines. The residual test we offer ensures precise and accurate detection of PEIpro® in virus samples with the lowest limit of detection (LOD) and quantification (LOQ). For the modalities of your virus sample testing, please contact our team.
Detection and quantification of residual PEIpro® transfection reagent during the manufacturing process of ATMPs. Our proprietary method allows the accurate detection and quantification of PEIpro® at each step of the downstream process to ensure that the purification process in place minimizes the presence of raw materials in the active substance (Option 1). In this case, the analysis should be performed on at least 3 independent productions. Alternatively, our PEIpro® residual test can be performed on each batch of final ATMP as a release Quality Control (Option 2).
Interested in more information on the methodology and validation characteristics (LOD, LOQ, accuracy and specificity)? Contact our Scientific support!