Overview

Specifications

Service

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

Method

Proprietary highly sensitive analytical HPLC/UV

Provided with

Analysis Report


Summary

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.

PEIpro residual test steps

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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Ordering information

Reference NumberName
600-236Residual PEIpro® test

Description

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.

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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!

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Bibliography

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Found 8 results :
Cell Linein vitro
in vivo
Delivered MoleculeReagentResults & Citations
CHOin vitroDNAPEIpro, PEIpro residual test
Poulain, A. et al. (2019)

J Biotechnol 296, 32-41
Reducing recombinant protein expression during CHO pool selection enhances frequency of high-producing cells
More details
HEK-293Tin vitroDNAPEIpro, PEIpro residual test
Leung, W. H. et al. (2019)

JCI Insight 5,
Sensitive and adaptable pharmacological control of CAR T cells through extracellular receptor dimerization
More details
Expi293F, HEK-293Sin vitroDNAPEIpro, PEIpro residual test
Heldt, CL. et al. (2019)

J Chromatogr B Analyt Technol Biomed Life Sci 1124, 173-179
Scalable method utilizing low pH for DNA removal in the harvest of recombinant adeno-associated virus vectors
More details
-in vitroDNAPEIpro, PEIpro residual test
Song, D. et al. (2019)

ACS Appl Mater Interfaces 11, 28720-28731
Cellular Targeting of Bispecific Antibody-Functionalized Poly(ethylene glycol) Capsules: Do Shape and Size Matter?
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A-498, HEK-293Tin vitromiRNA, siRNAPEIpro, PEIpro residual test
Wang, W. et al. (2019)

Apoptosis ,
MAGI1 mediates tumor metastasis through c-Myb/miR-520h/MAGI1 signaling pathway in renal cell carcinoma
More details
SJ293TSin vitroDNAPEIpro, PEIpro residual test
Bauler, M. et al. (2020)

Mol. Ther. Methods. Clin. Dev. 17, 58-68
Production of Lentiviral Vectors Using Suspension Cells Grown in Serum-free Media
More details
HEK-293in vitroDNAPEIpro, PEIpro residual test
D'Eall, C. et al. (2019)

Immunol Cell Biol ,
Modulating antibody-dependent cellular cytotoxicity of epidermal growth factor receptor-specific heavy-chain antibodies through hinge engineering
More details
CHO-Sin vitroDNAPEIpro, PEIpro residual test
Matveev, A. L. et al. (2019)

PLoS One 14, e0215075
Post-exposure administration of chimeric antibody protects mice against European, Siberian, and Far-Eastern subtypes of tick-borne encephalitis virus
More details