Bioprocess Kits
Bioprocess QC ELISA kits for biologics, vaccines & cell and gene therapy
Quantify process- and product-related impurities at every stage of manufacture — host cell proteins, residual DNA/RNA, endotoxin, viral-vector titer and anti-PEG antibodies — with validated, ISO 13485 immunoassays.
Solutions for Every Modality
Impurity and quality-control assays tailored to your development platform.
Cell & Gene Therapy
Detect host cell-derived impurities, serum residuals (BSA), cytokines, growth factors, Benzonase and Mycoplasma.
View cell & gene therapy kitsVaccine Development
Detect host cell-derived impurities, Benzonase/DNase/RNase, Protein A and other process residuals.
View vaccine impurity kitsBiosimilars & Biologics
Sensitive detection of host cell-derived impurities, endotoxins, enzymes, BSA and other process-related impurities.
View biosimilar & biologics kitsDetect All Bioprocess Impurities
Filter the full bioprocess 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 therapy, vaccine development and biosimilar 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 six 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 are bioprocess QC ELISA kits?
Bioprocess quality-control ELISA kits quantify process- and product-related impurities generated during biopharmaceutical manufacture — including host cell proteins (HCPs), residual DNA/RNA, enzymes, viral-vector components, endotoxin and anti-PEG antibodies — to support characterisation of critical quality attributes (CQAs).
Which host cell protein (HCP) ELISA kits are available?
Assay Genie offers HCP ELISA kits for the most common expression systems: E. coli, CHO, HEK293, Pichia and VERO, in both PharmaGenie and standard formats for biologics and biosimilar development.
What impurities can I detect?
The range covers host cell proteins, residual contaminants (Benzonase, BSA, dsRNA, T7 RNA polymerase, RNase inhibitor, trypsin, cell-free DNA, HIV-1 p24), viral vector/lentivirus titer, cellular markers and cytokines, endotoxin (LPS) and anti-PEG IgG/IgM across species.
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 CQAs aligned with FDA (21 CFR 210/211), EMA and ICH requirements. Selected kits use NIBSC/WHO (90/636) reference calibration.
What sample types and workflows are supported?
Kits are optimised for upstream and downstream process samples in cell & gene therapy, vaccine development and biosimilar/biologics manufacture.
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 Bioprocess QC Assay?
Tell our PhD-level technical team which impurity and expression system you're working with, and we'll help you choose or customise the right kit.
Talk to Our Team Browse Bioprocess Kits