In the diagnostics industry, analytical reliability is mission critical. Every assay, whether immunodiagnostic (ELISA, chemiluminescence), molecular diagnostic (PCR/qPCR, NGS), or biosensor-based (e.g., glucose oxidase in blood glucose monitoring), requires custom-designed analytical methods that ensure accuracy, reproducibility, and regulatory acceptance.
At Creative Enzymes, we provide enzyme-based custom analysis method development tailored to the real-world conditions of in vitro diagnostics (IVD). Unlike generic enzyme testing labs, our services replicate diagnostic matrices, account for biological interferences, and comply with international guidelines (CLSI, IFCC, ICH), ensuring your enzyme-powered products move smoothly from R&D to regulatory approval.
Integrated Workflow
We follow a five-step closed-loop process that ensures methods are not only scientifically sound but also regulatory-ready:
Service Portfolio
At Creative Enzymes, we combine enzyme engineering expertise with regulatory-grade validation to deliver custom analysis method development that addresses the full lifecycle of diagnostic enzyme products. Our portfolio is built on three pillars: design & discovery, analytical validation, and process scalability, ensuring that your diagnostic products achieve robust performance, regulatory compliance, and market readiness.
Custom Enzyme Design & Optimization
Tailored Enzyme Engineering
- Directed evolution, rational design, and computational biology for enzymes optimized in stability, activity, and substrate specificity.
- Site-directed mutagenesis to remove interfering activities that could compromise diagnostic accuracy.
Expression & Purification Options
- Multiple expression hosts: E. coli, yeast, insect, and mammalian cells.
- Production in different formats: full-length, truncated, tagged or untagged enzymes to fit assay needs.
Comprehensive Characterization
- Determination of kinetic constants (Km, Vmax).
- Assessment of thermal and pH stability under assay-relevant conditions.
- Verification of purity to ensure no interfering proteins disrupt ELISA/CLIA signal readouts.
Value to Clients: Diagnostic developers receive enzymes purpose-built for their assay, reducing downstream troubleshooting and regulatory rejection risks.
High-Throughput Screening & Profiling
Compound & Substrate Profiling
- Rapid screening of candidate enzymes across multiple substrates, inhibitors, and biological matrices.
- Functional comparison of wild-type vs. engineered variants.
Diagnostic-Relevant Performance Metrics
- Activity reproducibility (CV <3%, IFCC aligned).
- Tolerance to serum, plasma, and interfering compounds (hemoglobin, bilirubin, lipids).
- Heatmaps and kinetic profiles to visualize enzyme performance under diagnostic-use conditions.
Rapid Assay Prototyping
- New assays developed in 1–2 weeks for feasibility studies.
- Flexible formats: absorbance, fluorescence, chemiluminescence, or real-time PCR.
Value to Clients: Faster decision-making, backed by comparative data that shows not only activity but also diagnostic-grade robustness.
Bioprocess Development & Scale-Up
Fermentation Process Development
- Scalable production workflows from µg lab scale to multi-gram pilot batches.
- Strain optimization and fermentation condition refinement.
Purification & Formulation
- Downstream purification strategies that preserve activity and stability.
- Development of lyophilized or liquid-stable formulations to extend shelf life in diagnostic kits.
Stability & Storage Solutions
- Real-time and accelerated stability testing under ICH guidelines.
- Freeze-drying and reconstitution efficiency testing to mimic kit rehydration steps.
Value to Clients: Smooth transition from bench to market, reducing risks in supply chain, batch-to-batch consistency, and regulatory inspections.
Analytical Method Development & Regulatory Validation
Endpoint & Kinetic Assays
- Development of colorimetric, fluorometric, and chemiluminescent assays.
- Real-time kinetic monitoring for enzymatic activity in complex matrices.
Potency & Bioassay Services
- Enzyme potency quantification aligned with EMA/FDA guidelines.
- Adaptation to IVD-specific acceptance criteria (e.g., reproducibility CV <3%).
Stability & Robustness Testing
- Interference analysis with diagnostic matrices.
- Accelerated decay testing at 37°C for long-term use simulation.
Method Validation & Regulatory Support
- ICH/CLSI/IFCC-compliant method validation.
- Preparation of validation documentation for regulatory dossiers.
Value to Clients: Ensures that enzyme-based assays pass regulatory scrutiny, avoiding delays during diagnostic validation and market launch.
Diagnostic-Focused Solutions
Immunodiagnostics
- HRP/alkaline phosphatase conjugates for ELISA/CLIA.
- Custom interference testing to ensure no false positives/negatives.
Molecular Diagnostics
- PCR/qPCR enzyme optimization for fidelity, processivity, and inhibitor tolerance.
- NGS enzyme validation to confirm reproducibility in high-throughput workflows.
POCT & Biosensors
- Enzymes engineered for stability in miniaturized, portable diagnostic platforms.
- Accelerated stability testing to simulate continuous use in glucose monitoring devices.
Companion Diagnostics (CDx)
- Enzyme validation in co-developed assays with therapeutic partners.
- Diagnostic sample testing workflows that demonstrate biomarker-driven assay performance.
Value to Clients: Access to a single partner who understands the nuances of different diagnostic platforms—reducing fragmentation in R&D outsourcing.
Quality & Compliance Integration
GMP-Inspired QC Services
- Batch release testing, reproducibility verification, and long-term stability monitoring.
Cross-Functional Integration
- Services designed to integrate seamlessly into client QC/QA pipelines.
Global Regulatory Alignment
- Methods aligned with IFCC, CLSI, ICH, Ph. Eur., and USP frameworks.
Value to Clients: Builds confidence that data generated with Creative Enzymes is regulatory-ready, easing the path to global submissions.
By combining expertise in enzyme design, screening, process development, analytical validation, and regulatory compliance, Creative Enzymes provides a truly end-to-end solution for custom analysis method development. This portfolio reflects the best practices of the global industry leaders while remaining uniquely focused on diagnostic-grade applications.
FAQs
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Q1. Why not use standard enzyme activity tests?
A1. Because diagnostic performance requires proof under real-world sample matrices—not idealized lab buffers. Standard tests miss interference and stability risks.
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Q2. How do you ensure reproducibility?
A2. We perform CV <3% reproducibility testing aligned with IFCC guidelines and regulatory standards.
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Q3. Can you adapt methods for new diagnostic platforms?
A3. Yes. We support ELISA, CLIA, PCR/qPCR, NGS, biosensors, and emerging POCT platforms.
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Q4. What makes Creative Enzymes different?
A4. We integrate enzyme engineering, process development, and regulatory-grade method validation, offering a one-stop solution from design to dossier.
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Q5: What is the typical timeline?
A5. 6–12 weeks for full method development and validation, with accelerated prototyping in 2–4 weeks when needed.
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