Enzymes Production and Engineering
High-performance enzymes are the backbone of modern in vitro diagnostic (IVD) systems, determining assay precision, stability, and reproducibility. At Creative Enzymes, we provide end-to-end enzyme production and engineering services — from gene construction and expression to molecular modification — ensuring diagnostic-grade enzymes tailored to each customer's platform and analytical application.
Our capabilities integrate bioprocess optimization, advanced purification, chemical and genetic conjugation, and molecular engineering, delivering enzymes optimized for performance, stability, and scalability. Through years of experience serving global diagnostic manufacturers, Creative Enzymes has established itself as a trusted partner for reliable enzyme solutions that comply with ISO 9001:2015 and meet EP/USP analytical standards.
Our production and engineering workflow is designed to guarantee consistency, scalability, and diagnostic reliability.
We begin with in silico design and codon optimization of enzyme genes for the chosen host system — bacterial (E. coli), yeast (Pichia pastoris, Saccharomyces cerevisiae), insect (Sf9, Hi5), or mammalian cells. Each expression strategy is selected according to the required post-translational modifications and folding complexity.
Using controlled bioreactor systems, our fermentation processes can be scaled from milliliter R&D batches to pilot or manufacturing scale. Parameters including pH, dissolved oxygen, feed rate, and induction timing are optimized by Design of Experiments (DoE) to achieve high yield and batch-to-batch reproducibility.
Multi-step purification — combining affinity, ion exchange, and size-exclusion chromatography — ensures enzyme purity above 95%. Formulation buffers and stabilizers are tailored for long-term storage, lyophilized kits, or liquid-stable reagent systems.
Conjugation techniques enable enzymes to interface with antibodies, nanoparticles, or solid supports, broadening their diagnostic utility. Creative Enzymes provides a suite of chemical and bio-orthogonal conjugation strategies designed for diagnostic precision.
Using crosslinkers such as maleimide, NHS esters, or click chemistry reagents, we perform site-specific conjugations that preserve catalytic activity. These enzyme-antibody conjugates serve as key components in ELISA, chemiluminescence, and lateral flow assays.
For biosensor and POCT platforms, we immobilize enzymes onto nanocarriers or sensor chips. The immobilization matrix is optimized for electron transfer efficiency, catalytic retention, and anti-leaching performance.
Each conjugated enzyme is tested for retained catalytic activity, binding efficiency, and signal linearity under physiological assay conditions.
Our enzyme engineering program combines rational design, computational modeling, and directed evolution to enhance enzyme kinetics and stability under diagnostic conditions.
We use structure-guided algorithms and molecular dynamics simulations to predict beneficial mutations in catalytic, binding, or surface residues. These insights guide targeted mutagenesis to improve turnover rate (kcat/Km), thermal tolerance, or pH range.
Iterative mutagenesis and library screening allow us to evolve enzyme variants with improved robustness. Automated microplate assays accelerate the identification of superior mutants for IVD systems.
Through residue substitution, disulfide bond introduction, or fusion with stability-enhancing domains, we extend enzyme shelf-life. For sensor applications, immobilization techniques maintain performance over extended use.
All enzyme products undergo multi-dimensional quality control and documentation aligned with ISO 9001, EP/USP, and IFCC standards:
Every batch is delivered with a Certificate of Analysis (CoA) including purity profile, activity data, and storage recommendations, ensuring seamless integration into diagnostic workflows.
To ensure optimal enzyme performance across diagnostic workflows, Creative Enzymes offers the following specialized sub-services under the Enzymes Production and Engineering platform:
| Sub-Service | Description |
|---|---|
| Enzymes Expression and Purification | High-yield recombinant expression and advanced purification systems for diagnostic-grade enzyme production. |
| Enzymes Conjugation | Site-specific enzyme–antibody and enzyme–nanoparticle conjugation technologies for ELISA and POCT applications. |
| Enzymes Engineering and Modification | Rational and directed enzyme engineering to enhance catalytic performance and stability. |
Q1. What is the typical workflow for enzyme production at Creative Enzymes?
Q2. Can you improve enzyme stability for high-temperature or lyophilized formats?
Q3. Are the produced enzymes suitable for diagnostic kit manufacturing?
Q4. What analytical data accompany enzyme deliveries?
Q5. Can Creative Enzymes support custom enzyme engineering projects?
