Therapeutic Enzymes and Enzyme Engineering
In the biopharmaceutical field, pharmaceutical enzymes, as key tools for direct disease treatment or drug production, are increasingly demonstrating their importance. As an important category of medicinal enzymes, therapeutic enzymes can directly participate in the disease treatment process in the form of protein drugs. By precisely catalyzing specific biochemical reactions in the body, they can effectively regulate pathological processes. They have shown great application potential in multiple therapeutic fields such as digestion, anti-inflammatory, and anti-tumor, such as trypsin, lysozyme, and L-asparaginase. However, natural enzymes generally have bottlenecks such as insufficient stability, high immunogenicity, short half-life, and poor targeting in the drug development process, which seriously restrict their clinical efficacy and practical application. Therefore, with the help of cutting-edge technologies such as rational design, directed evolution, and AI prediction, "de novo design" and "deep optimization" of natural therapeutic enzymes to obtain efficient, stable, and safe next-generation engineered therapeutic enzymes has become a key path to breaking through the current drugability challenges.
As a biotechnology company focused on cutting-edge enzyme science, Creative Enzymes Diagnostic transforms innovative enzyme engineering concepts into highly effective and safe therapeutic enzyme drugs, injecting core momentum into your drug development pipeline.
Figure 1. The gap between science and translation into therapies for rare diseases.(Tambuyzer E, et al, 2020)
Creative Enzymes Diagnostic provides integrated solutions for the development of therapeutic enzymes, covering the entire innovation chain from new enzyme discovery and engineering modification to process development..
| Therapeutic enzyme discovery and screening | Metagenomic/genome mining | Discovering therapeutic enzyme genetic resources with novel functions from specialized environments |
|---|---|---|
| Functional characterization and evaluation | Systematically evaluate candidate enzymes for catalytic activity, substrate specificity, kinetic parameters, and preliminary biological activity | |
| Rational enzyme design and directed evolution | Rational design | Based on the protein's three-dimensional structure, computer simulations are used to perform key site mutations to precisely improve the enzyme's catalytic efficiency, stability, or reduce immunogenicity |
| Directed evolution | By constructing mutation libraries and utilizing high-throughput screening techniques, we rapidly identify evolved enzyme variants with superior performance | |
| AI-driven intelligent design | AI machine learning models are used to analyze sequence and structural data to predict optimal mutation combinations, significantly improving the success rate and efficiency of enzyme engineering | |
| Drugability optimization | Stability improvement | Enhance enzyme stability under physiological conditions (temperature, pH) and extend half-life |
| Improving immunogenicity | Humanization minimizes the risk of potential immune responses. | |
| Optimizing catalytic efficiency | Modify the active site of an enzyme to improve its affinity for specific substrates and conversion rate | |
| Optimizing solubility and expression levels | Optimize protein sequences to increase solubility and yield in production systems | |
| Targeting and delivery system integration | Constructing fusion proteins | Fusion of therapeutic enzymes with antibody fragments (scFv), targeting peptides, or Fc fragments enables tissue/cell targeting or extends their in vivo half-life |
| Analytical and process development | Analytical method development | Establish rigorous analytical methods for activity, purity, and impurities to support quality control and regulatory submission |
| Production process development | Provide customers with small-scale/pilot process development services from cell line construction, upstream fermentation/cell culture to downstream purification, laying the foundation for large-scale production |
Figure 2. General Service process.(Creative Enzymes)
Creative Enzymes offers comprehensive Enzyme Replacement Therapy (ERT) development and production services, designed to support biotechnology and pharmaceutical partners from early-stage concept to manufacturing readiness. Our team provides enzyme candidate optimization, including stability enhancement, immunogenicity reduction, and activity improvement through rational design and directed evolution. In addition, we establish robust expression systems, develop scalable upstream and downstream processes, and perform formulation, analytical method development, and quality characterization to meet regulatory expectations.
Leverage our enzyme engineering expertise to reduce risk and accelerate your therapeutic enzyme projects. Contact our business development team to explore a potential partnership!
