De Novo Assay Development Powered by In-House Reagents
Unlock True Control Over Your Bioanalytical & GMP Release Testing
At Prolytix, we don’t just run assays—we build them from the ground up. By designing de novo bioanalytical and GMP release assays around reagents we manufacture under our ISO 9001-certified quality system, you gain unmatched confidence in every result.
Why Integrated Reagent + Assay Design Matters
Greater Control Over Performance
We define and monitor every critical component—recombinant proteins, antibodies, assay-specific reagents—to ensure your assay behaves exactly as intended.
Seamless Method Development & Validation
With reagents on-demand, method tweaks and validation studies move faster and smoother.
Long-Term Lot Consistency
Stability programs demand reproducibility. Our in-house manufacturing guarantees consistent lots over months or years.
Rapid Response for Custom or Rare Needs
When standard reagents fall short, we adapt or create new ones—often in days, not weeks.
Custom Reagent Solutions Tailored to You
| Offering | What It Means for Your Program |
|---|---|
| Expertise | 35+ years creating custom blood-coagulation proteins; pioneers in plasma-fractionation evolution |
| In-House Manufacturing | Over 150 plasma & tissue proteins produced under one roof |
| Purification & Modification | Fine-tune our proteins—or yours—to your exact specifications |
| IVD & POC Device Reagents | Custom antibodies, ELISA reagents, control chemistries for handheld diagnostic platforms |
Comprehensive Reagent Characterization
To ensure every in-house reagent meets the highest standards, we perform thorough characterization across multiple critical attributes:
| Characterization Category | Description |
|---|---|
| Physicochemical Properties | Assess molecular weight, structural integrity, and stability profiles. |
| Biological Activity & Potency | Confirm functional performance in relevant bioassays. |
| Immunochemical Properties | Verify antigen–antibody interactions, specificity, and cross-reactivity. |
| Purity, Impurities & Contaminants | Quantify host-cell proteins, endotoxins, and other adventitious agents. |
| Quantity | Accurate concentration measurements for dosing and formulation. |
| Protein ID & Quantitation | Mass spectrometry or peptide mapping to confirm identity and abundance. |
| Gel-Band Identification | SDS-PAGE analysis to verify size and detect degradation products. |
| Aggregation | SEC or DLS to detect and quantify oligomers or high-molecular-weight species. |
| Charge Heterogeneity | Isoelectric focusing or ion-exchange chromatography to profile charge variants. |
By integrating this deep characterization with our custom reagent manufacturing and assay design, Prolytix delivers reagents and methods that are robust, reproducible, and fully traceable—empowering you to advance drug development with confidence.
Why Clients Choose Prolytix
Unrivaled Customization
From concept to delivery, your assay components are built exactly as you need them.
Industry-Leading Scientists
Decades of collective experience in protein chemistry, coagulation, hematology, and assay validation.
Regulatory-Ready Methods
Every reagent and assay step is documented under our ISO 9001 quality system, ensuring audits and inspections go smoothly.
Collaborative Partnership
We integrate with your team, adapting specifications in real time to meet your evolving project goals.
