At Elise Biopharma, we specialize in the development and production of high-quality enzymes and reagents essential to modern diagnostics. By combining rigorous research, advanced process control, and uncompromising quality standards, we ensure reliable, reproducible results for a wide range of clinical applications. From acute care testing to chronic disease monitoring, our enzyme portfolio supports both established diagnostic markers and next-generation assays.
Core Diagnostic Enzymes
- Arylacylamidase
- Key Function: Hydrolysis of specific substrates for the detection of acetaminophen and other analytes in serum.
- Clinical Use: Routine drug monitoring, toxicology assessments, and enzymatic assays in automated clinical chemistry platforms.
- Advantages: High specificity, consistent performance across varying matrices, and compatibility with a range of assay formats.
- Beta-Hydroxybutyrate Dehydrogenase (β-HBDH)
- Key Function: Catalyzes the conversion of beta-hydroxybutyrate to acetoacetate, critical in measuring ketone body levels.
- Clinical Use: Rapid detection and monitoring of diabetic ketoacidosis (DKA), enabling timely intervention in emergency settings.
- Advantages: Enhanced stability, minimal interference in blood or serum samples, and optimized activity suitable for both point-of-care (POC) and high-throughput lab analyzers.
- Salicylate Hydroxylase
- Key Function: Catalyzes the hydroxylation of salicylate to catechol, forming the basis for salicylate assay in toxicology panels.
- Clinical Use: Diagnosis of salicylate (aspirin) poisoning, crucial in emergency and critical care.
- Advantages: High substrate specificity and robust performance under a variety of assay conditions, ensuring rapid, accurate results.
Development Pipeline
- Uricase
- Application Focus: Used in colorimetric assays to measure uric acid levels, aiding in the diagnosis of gout and hyperuricemia.
- R&D Emphasis: Enhanced thermostability and minimized immunogenicity, expanding utility in both traditional clinical analyzers and newer diagnostic platforms.
- Phenylalanine Dehydrogenase
- Application Focus: Targeted for newborn screening and metabolic disorder tests, particularly in detecting phenylketonuria (PKU).
- R&D Emphasis: Optimization for high-throughput screening, consistent activity in varied assay matrices, and potential for near-patient testing.
- Diaphorase
- Application Focus: Critical for redox-based assays, colorimetric endpoint reactions, and as a coupling enzyme in multiple diagnostic pathways.
- R&D Emphasis: Improved stability and specificity to broaden application across enzymatic testing kits, point-of-care diagnostics, and research assays.
Clinical Applications
- DKA Monitoring:
Beta-hydroxybutyrate dehydrogenase is integral to ketone body assays, providing rapid identification of diabetic ketoacidosis in patients with type 1 or type 2 diabetes experiencing acute episodes. - Salicylate Poisoning Detection:
Salicylate hydroxylase-based assays are vital in emergency toxicology, quickly determining if critical salicylate levels pose a life-threatening risk. - Metabolic Condition Tests:
From hyperuricemia (linked to gout and kidney diseases) to PKU screening in newborns, our enzymes provide robust, efficient solutions that meet the accuracy demands of modern clinical workflows.
Why Choose Elise Biopharma for Diagnostic Enzymes & Reagents?
- High Purity & Consistency
Each enzyme is produced under strict process controls in cGMP-aligned facilities. Our robust purification and quality control measures ensure minimal lot-to-lot variability. - Advanced Process Optimization
Leveraging decades of bioprocess engineering experience, we optimize fermentation parameters, downstream purification steps, and formulation conditions to achieve top-tier activity and stability. - Regulatory Compliance
With ISO 13485, ISO 9001, and FDA registrations, our manufacturing processes satisfy stringent global requirements for medical devices and in vitro diagnostics, simplifying your path to market. - Customization & OEM Partnerships
We offer custom formulations, fill/finish operations, and specialized packaging to support OEM collaborations. Whether you need a bulk supply or a private-labeled reagent kit, our team can tailor solutions to your unique specifications. - Dedicated R&D Pipeline
We continually invest in enzyme discovery and improvement programs—focusing on enhanced thermostability, substrate specificity, and integration into emerging diagnostic platforms.
Integrated Approach & Collaborative Support
At Elise Biopharma, we understand that a reliable diagnostic enzyme is only one piece of the puzzle. Our collaborative approach ensures seamless integration with your test systems, whether you’re developing a new clinical chemistry assay or refining an established diagnostic panel. Our technical specialists and project managers work alongside you at every stage—from feasibility studies and pilot batches to full-scale manufacturing and regulatory submissions.