Creative Enzymes shows complete dedication to all enzyme-related solutions by providing stabilization and formulation services. We offer the whole service package to address enzyme stability issues, ranging from stabilization, stability tests, to formulation development. Our expertise will ensure your product of high efficacy, quality, and safety, regardless of the purity, identify, or quantity of the enzymes.
Enzyme formulation is one last and important step in commercializing an enzyme containing product. The main purpose of formulation is to preserve the enzyme in a ready-to-use form until consumed by the customer. End customers are only interested in the safety, stability, and aesthetics of the products on the shelf. Therefore, the product is only completed when it goes into the final package. At Creative Enzymes, we understand the importance of stable enzyme activity and will help you keep the enzymes stable during long-term storage. We also perform proper aging tests that predict the shelf life of an enzyme product using acceleration tests and kinetic models. In addition, we are happy to develop and optimize the product formulation for a specific enzyme product.
1) Enzyme stabilization
One of the major barriers to the use of enzymes in biotechnology is their insufficient stability under processing conditions. Enzyme products may also be exposed to harsh environments during storage and transportation, including high temperatures, high pH, UV light, and pressure changes. Stabilization is the key to protect the enzymes and maintain their activities. However, it should be noted that the enzymes are often stored in a condition that is quite different from its optimal active condition. Therefore, studying enzyme stabilization is in fact separated from enzyme assay development. Creative Enzymes is able to use multiple tools to sustain the enzyme activity over a long period of time. We have helped customer in pharmaceutical, chemical, and nutritional (human and animal) industries with the stabilization service.
2) Enzyme stability tests
Assessment of the stability of an enzyme product is the key for development and quality control. Although most manufacturers perform the long-term storage test, which would give the most realistic answers to enzyme stability, the test takes months or years to finish. Therefore, accelerated aging is used to get a quick estimation on the lifetime of the enzymes. The method is simple, but often fails to give the real answer for two main reasons. First, the chemistry of enzyme decomposition or deactivation could substantially change at higher temperatures. Second, there are other factors that also significantly change the enzyme stability in real storage conditions but not well controlled in the aging test, such as UV radiation and humidity. Based on the extensive understanding of enzyme degradation chemistry, Creative Enzymes is capable of properly testing the enzyme stability under specific conditions that involve all critical factors. We are also aware of the complication of the aging test and has accumulated years of experience on establishing the acceleration model. With the correct kinetic model, we can set up fine correlations between the accelerated aging result and the life time under ambient conditions.
The main purpose of enzyme formulation is to package and store the enzyme in the specific condition that could keep the year-long research results of activity enhancement, efficiency optimization, and stabilization. It is the final and key step that is responsible to maintain high enzyme stability while meeting high-standard requirements of different industries: distribution and low toxicity for pharmaceutical use, robust performance and low environmental impact for institutional and industrial use, biocompatibility for nutritional applications. Enzyme formulation could vary largely in formats and purposes. In addition, formulation of pharmaceutical and nutritional products often requires use of GMP processes and chemicals listed in FDA monographs. Creative Enzymes completely understands the challenges and potential concerns in enzyme formulation. We will make sure the product quality is well protected while complying with possible regulations.
Creative Enzymes provides the unique service in enzyme stabilization and formulation. We have worked closely with the customers to understand meet their needs in this last step of delivering an enzyme product. With all the expertise and experience in house, we are confident to solve any challenge you may have during commercializing the enzyme product.
Figure: Non-aqueous formulation is an important approach to enzyme stability.
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