End-to-End Host Cell Protein and Process Impurity Assay Development
From antibody generation to validated assay to single-use kit — Quantera BioAnalytics builds the impurity testing methods biopharma programs depend on, and helps teams fix the ones that aren't working.
What We Do
Host cell protein (HCP) ELISA development, from antigen and antibody generation through final assay lock
Antibody generation programs optimized to consistently achieve greater than 90 percent HCP coverage
Individual and process-specific impurity ELISAs (residual Protein A, insulin, and other product or process-related impurities)
Enzymatic activity assay development for residual enzyme and protease impurities
Single-use ELISA kit conversion, so assays move from bench method to deployable product
Assay troubleshooting and rescue for existing methods showing non-parallelism, poor recovery, or drifting standards
Tech transfer support between sites, CDMOs, and organizations
Fit-for-purpose qualification, formal qualification, and full ICH Q2-aligned method validation
Regulatory strategy grounded in FDA, EMA, ICH, USP, and Ph. Eur. expectations
How We Work
Antibody Generation — "We generate and screen antibodies for broad, consistent HCP coverage."
Assay Development — "We design and optimize ELISA and enzymatic activity methods around your process."
Optimization — "We refine sensitivity, specificity, and robustness before qualification begins."
Qualification & Validation — "We execute fit-for-purpose qualification or full ICH Q2 validation, matched to your program stage."
Tech Transfer — "We move validated methods into your labs or your CDMO's, with full transfer documentation."
Kit Conversion (optional) — "We package proven assays into single-use kits for routine use."
These challenges require more than standard method development — they require specialized expertise.
Quantera BioAnalytics provides strategic scientific consultation for impurity assay development across the biopharmaceutical lifecycle. With early scientific intervention we can prevent costly validation delays and regulatory risk.
Whether you need a new assay built from scratch or help fixing one that's already failing, talk to us before your next milestone deadline.
Schedule a Consultation Today.