Biosimilars & Biologics ELISA Kits
Biosimilar & biologic impurity detection ELISA kits
Ensure product purity and regulatory compliance across biologics and biosimilar manufacture — host cell proteins, residual DNA, enzymes, BSA 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 kitsCell & Gene Therapy
Impurity, viral-vector titer and cytokine assays for advanced therapies.
View cell & gene therapy kitsDetect Biologic & Biosimilar Impurities
Filter the biosimilar & biologics 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 biologics 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 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
Which HCP ELISA kits are available for biologics and biosimilars?
Assay Genie offers host cell protein ELISA kits for the most common expression systems used in biologics manufacture: E. coli, CHO, HEK293, Pichia and VERO, in both PharmaGenie and standard formats.
What residual contaminants can I detect?
The range covers residual DNase I, dsRNA, Benzonase, BSA, porcine trypsin and FLAG-tag (DYKDDDDK) affinity-tag residuals generated during purification.
Do you offer anti-PEG antibody assays for PEGylated biologics?
Yes. Anti-PEG IgG and IgM ELISA kits are available across human, monkey, mouse, rat and rabbit for immunogenicity and PK research on PEGylated biologics.
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 Biologics 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 Kits