Services
Comprehensive Enzyme Services for Diagnostic Innovation
At Creative Enzymes, we provide end-to-end enzyme solutions tailored to diagnostic applications—from molecular design to quality validation. With decades of biochemical expertise, ISO-aligned quality systems, and a proven track record in enzymology, we help diagnostic manufacturers, research institutions, and biotech innovators accelerate assay development and achieve diagnostic-grade performance consistency.
Our service portfolio covers enzyme production, engineering, conjugation, QC/QA, and customized analytical method development, all optimized for IVD reagent, POCT device, and molecular diagnostic platforms.
Enzyme Expression and Purification
We offer scalable enzyme expression and purification services covering microbial, yeast, insect, and mammalian systems. Each project begins with codon-optimized gene design, followed by expression vector construction and host screening. Our purification pipelines employ affinity, ion-exchange, and size-exclusion chromatography to achieve >95% purity verified by SDS-PAGE and HPLC. Diagnostic-grade enzymes are further evaluated for endotoxin content (<0.1 EU/mg), residual host-cell protein, and batch-to-batch consistency, ensuring suitability for sensitive clinical assays.
Enzyme-antibody and enzyme-nanoparticle conjugates are indispensable in ELISA, chemiluminescent, and biosensor platforms. We perform site-specific conjugation using heterobifunctional crosslinkers or enzyme-directed mutagenesis to preserve catalytic activity. Each conjugate is characterized for conjugation ratio, specific activity retention, and long-term stability, ensuring consistent signal generation and minimal background interference in diagnostic kits.
Enzyme Engineering and Modification
Our enzyme engineering team employs directed evolution, rational design, and site-saturation mutagenesis to tailor catalytic efficiency, thermostability, and pH tolerance. We engineer enzymes that remain active in challenging sample matrices (e.g., serum, plasma, urine) and under lyophilization or high-salt storage conditions. These optimizations improve shelf life and enhance diagnostic accuracy across global climates and supply chains.
Figure 1. Enzyme Engineering (Otte, K.B. and Hauer, B., 2015)
Enzyme Purity Analysis
We apply multi-modal purity evaluation combining electrophoretic, chromatographic, and immunological techniques.
This comprehensive framework guarantees regulatory compliance (CLSI, IFCC, and ISO 13485 standards) and assures that each enzyme lot performs reliably in diagnostic manufacturing pipelines.
Enzyme Activity and Stability Analysis
Diagnostic reliability hinges on consistent enzymatic kinetics. We conduct full activity profiling (Km, Vmax) under assay-specific buffers and substrates. Thermal and chemical stability tests, including accelerated aging and freeze-thaw cycles, assess product robustness. Heatmaps and kinetic curves are provided to visualize enzyme tolerance to hemoglobin, bilirubin, and lipids—ensuring compatibility with real biological samples.
Custom Analytical Method Development
Every diagnostic kit possesses unique detection chemistry. Off-the-shelf QC protocols often fail to capture these nuances. Our scientists design custom analytical methods that simulate real-world assay conditions—be it colorimetric creatinine detection or chemiluminescent lipid quantification. All custom methods undergo validation according to CLSI EP and IFCC protocols, facilitating regulatory acceptance and technology transfer to client QC/QA systems.
Creative Enzymes offers end-to-end IVD reagent development and contract manufacturing services, covering enzyme formulation, stabilization, and reagent blending. We specialize in colorimetric, fluorescent, and biosensor-based platforms, supporting OEM and ODM production under strict confidentiality. Our manufacturing is aligned with ISO 13485 and GMP-like environments, providing formulation optimization, fill-finish, and stability testing for seamless transition from prototype to market.
Our consulting team integrates decades of enzymology expertise with diagnostic application insight. Services include:
By combining scientific and regulatory perspectives, we help clients minimize assay variability, shorten development cycles, and enhance product differentiation.
Beyond diagnostics, we extend our expertise into therapeutic enzyme discovery and engineering, focusing on Enzyme Replacement Therapy (ERT) and next-generation biocatalysts. Services encompass recombinant production, glycoengineering for pharmacokinetic optimization, and in-vitro functional assays. Although not intended for clinical use, these pre-clinical services enable clients to advance from early feasibility to IND-enabling research efficiently.
Our integrated development framework unites enzyme design, engineering, QC, and validation into a single streamlined pipeline. We combine bioinformatics, AI-assisted modeling, and high-throughput screening to accelerate discovery. Each project concludes with a full validation package—covering reproducibility (CV <3%), stability under stress, and batch-release testing. This ensures that every enzyme product or reagent we deliver meets global diagnostic expectations for robustness and reliability.
Q1. Are your enzyme services compliant with diagnostic regulatory standards?
Q2. Do you offer OEM or private-label production for diagnostic reagent manufacturers?
Q3. How do you ensure batch-to-batch consistency?
Q4. Can you develop customized enzymes for specific diagnostic kits?
Q5. What types of assays or detection platforms do you support?
