Gene Therapy Formulation Polyethylenimine Residue Testing

Residues of the transfection agent polyethylenimine (PEI), a widely used cationic polymer transfection vector for transient gene expression for the production of recombinant proteins in gene therapy as well as in viral vector production, are of particular concern in gene therapy formulations. Despite the advantages of high transfection efficiency and easy escape from lysosomes, PEI residues may pose a potential risk to patients, as PEI is not readily biodegradable in vivo and is somewhat toxic. CD Formulation has extensive experience in providing services for gene therapy formulation development and quality control testing. Our state-of-the-art testing platform is capable of providing comprehensive and accurate testing for residues, including PEI, and thus plays an important role in ensuring the safety and efficacy of gene therapy products.

The Importance of Gene Therapy Formulation Polyethylenimine Residue Testing

PEI is very easy to bind negatively charged DNA molecules, form complexes and transfect into adherent or suspension cells, which are widely used in the field of gene therapy formulations. However, PEI is not easily biodegradable in vivo and becomes enriched, so it is necessary to strictly control PEI residues in gene therapy formulations to avoid potential risks to organisms.

Explore Our Gene Therapy Formulation Polyethylenimine Residue Testing

Highly sensitive detection method

We use high-performance liquid chromatography with evaporative light scattering detector (HPLC-ELSD), a method suitable for the analysis of semivolatile and non-volatile compounds that cannot be measured by UV detector, especially for PEIs that lack UV-absorbing groups and are not volatile. This method can accurately analyze the residues of transfectants PEIs in the formulations quantitatively, with a high sensitivity and good reproducibility.

Sample pretreatment

Before sample analysis, we dilute and treat the samples appropriately to eliminate matrix interference and improve the recovery of PEI in the samples. For example, the use of a mixture of acidic organic reagents and water as a sample pretreatment reagent can effectively eliminate matrix interference and improve PEI recovery.

Process optimization

During the production of viral vectors, we reduce PEI residues by optimizing the process, such as improving the virus purification step, reducing the amount of PEI used, and adopting more effective removal and purification techniques.

Quality control monitoring

PEI residues are monitored at different stages of the production process to ensure that each step meets predetermined quality standards. This includes testing for PEI residues during clarification, chromatographic purification, and ultrafiltration concentration steps of viral vector production.

Our Technologies for Gene Therapy Formulation Polyethylenimine Residue Testing

When choosing the residue detection method for PEI transfection reagents in gene therapy formulations, we need to choose the appropriate PEI transfection conditions according to the experimental requirements and transfected cell types before using PEI for transfection, and strictly follow our specific experimental procedures to ensure the accuracy of the test results and avoid the interference of PEI residue on the experimental results.

Highlights of Our Gene Therapy Formulation Polyethylenimine Residue Testing

• We have a research and technical team with rich expertise and experience, constantly optimizing detection methods and experimental procedures, aiming to help clients accurately detect PEI residues in gene therapy formulations.
• We ensure high reproducibility and accuracy of test results, in addition to ensuring that the experimental process complies with relevant regulations to ensure service compliance.
• We have an advanced technology platform characterized by high sensitivity and wide linear range detection, which can accurately detect PEI residues at low concentrations in gene therapy formulations.
• We have specialized columns and detectors to continuously optimize the detection process and improve detection efficiency.

Published Data

CD Formulation performs comprehensive, accurate testing of residues, including PEI, to ensure the safety and efficacy of gene therapy formulations. We ensure the reliability and accuracy of our tests and look forward to working with you. If you are interested in us, please feel free to contact us.