Creative Enzymes shows complete dedication to all enzyme-related solutions by providing stabilization and formulation services. We offer the whole package of services to address enzyme stability issues from stabilization, stability tests, to formulation development. Our expertise will assure your product in 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. Nonetheless, the step has not yet received enough notice for its key role in effectively delivering the intended performance of the product. The main purpose of formulation is to preserve the enzyme in a ready-to-use form until consumed by the customer. Many companies spent a significant amount of resource and time on developing and testing the new enzyme product in details to deliver perfect biochemistry, however, final 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 the end, we are happy to develop and optimize the product formulation for a specific enzyme.
1. Enzyme stabilization
Enzyme products may be exposed to harsh environments during storage and transportation, including high temperatures, high pH, UV light, and pressure changes.Stabilizationis the key to protect the enzymes and maintain their activities. Similar to the concept of enzyme assay development, enzyme stabilization could also use a large design matrix for experimental tests, involving many factors, including solvents, pH, organic, inorganic additives, loading levels etc., at various values. However, it should be noted that the enzymes are often stored in a condition that is quite different from its optimal active condition. The enzymes could be reversibly inhibited or temporarily deactivated for the purpose of preservation. Upon final use or leaving the container, the dormant enzyme would be brought to active again by the using environment. 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 and is not helpful in a quick development or for quality control purposes. Therefore, accelerated aging is used to get an quick estimation of the lifetime of the enzymes, in most cases, by heating the samples to an elevated temperature. 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. As a result, the stability observed at the aging test is the outcome of completely different reactions and should not be used to estimate the shelf life. 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 lifetime under ambient conditions.
3. Enzyme formulation
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. For example, keeping enzymes and reactive species physically segregated in granular particles is straightforward and effective. However, bottling enzymes and oxidizing bleaches in a clear liquid is somewhat disturbing. In addition, formulation of pharmaceutical and nutritional products often requires use of GMP certified materials or 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.
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