Cell & Gene Therapy Kits
Cell & gene therapy QC ELISA kits
Support quality, safety and regulatory compliance in advanced therapy manufacture — host cell proteins, residual DNA/RNA, lentiviral vector titer, cytokines, endotoxin and anti-PEG antibodies — with validated, ISO 13485 immunoassays.
Part of Our Bioprocess QC Range
Explore the full impurity-detection portfolio and related development platforms.
All Bioprocess QC Kits
Browse the full impurity-detection range — 33 validated ELISA kits across six impurity classes.
View all bioprocess kitsVaccine Development
HCP, DNA/RNA, ovalbumin and endotoxin impurity assays for vaccine QC.
View vaccine kitsBiosimilars & Biologics
HCP, residual DNA, enzymes and anti-PEG assays for biologics.
View biosimilar kitsDetect Advanced-Therapy Impurities
Filter the cell & gene therapy QC range by impurity type, or search by target or catalog number.
Regulations & Guidelines
Built for quality-control research in regulated bioprocess workflows.
NIBSC/WHO Calibration
Selected kits use NIBSC/WHO (90/636) reference standards for alignment with internationally recognised quantitation guidelines.
ISO 13485:2016
Manufactured under an ISO 13485:2016 quality management system for consistent, traceable performance.
Pharmacopeia Verified
Assessed for specificity, accuracy, precision, linearity, LOQ, LOD, durability and stability.
FDA / EMA / ICH Aligned
Supports characterisation of critical quality attributes aligned with FDA (21 CFR 210/211), EMA and ICH requirements.
All bioprocess PharmaGenie ELISA kits are for research use only (RUO), optimised for cell and gene therapy development and quality control.
Why Choose Our Bioprocess ELISA Kits?
Reliable, validated immunoassays for upstream and downstream impurity monitoring.
Broad Choice
Detect upstream and downstream process- and product-related impurities across multiple impurity classes.
Rigorously Validated
Spike-recovery, linearity, range, CV (%) and standard curves documented for each kit.
Simple Protocol
Streamlined workflows for accurate performance and consistent, reproducible results.
High Quality
Specific and sensitive analyte detection for confident impurity quantification.
What Researchers Are Saying
Serving industry and academic bioprocess labs worldwide.
“Assay Genie provided a critical ELISA kit that is very difficult to find on the market. Not only did this kit work dependably well, but it also provided me with the measurement sensitivity that I needed to evaluate my samples.”
Erika, on Trustpilot“The support staff are very easy to deal with. The delivery is quick and efficient and the ELISA kits are great quality.”
Amy O'Rahilly, on TrustpilotWhy Choose Assay Genie
Fast Delivery
7–10 business day lead time after manufacture.
Highly Cited
Trusted in peer-reviewed bioprocess and analytical research.
PhD-Level Support
Our team is trained to a PhD level to support your assay questions.
Frequently Asked Questions
What impurities do cell & gene therapy QC kits detect?
The range quantifies host cell proteins (HEK293, E. coli), residual nucleic acids (dsRNA, T7 RNA polymerase, RNase inhibitor), Benzonase, HIV-1 p24 residual, lentiviral vector titer, cytokines (CRS), endotoxin (LPS) and anti-PEG antibodies.
Can I titer lentiviral vectors?
Yes. The Lentivirus Titer p24 PharmaGenie ELISA Kit quantifies p24 capsid protein for lentiviral vector titer determination in cell and gene therapy manufacture.
Do you support cytokine release syndrome (CRS) monitoring?
Yes. The Cytokine Multiplex PharmaGenie ELISA Kit supports CRS monitoring; a Human CAR-T CRS 18-Plex Panel is also available in the full bioprocess range.
Are the kits validated and regulatory-aligned?
Yes. Kits are validated for spike-recovery, linearity, range, CV (%) and standard curves, manufactured under ISO 13485:2016, and support characterisation of critical quality attributes aligned with FDA (21 CFR 210/211), EMA and ICH requirements.
Are these kits for research use only?
Yes. Assay Genie bioprocess PharmaGenie ELISA kits are for research use only (RUO) and quality-control research applications, not for diagnostic use.
Need a Cell & Gene Therapy QC Assay?
Tell our PhD-level technical team which impurity, vector or expression system you're working with, and we'll help you choose or customise the right kit.
Talk to Our Team Browse Kits