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engineering — an iterative process that dramatically improves enzymatic activity , enzyme stability , binding affinity and / or specificity . Because enzyme engineering requires creating and selecting recombinant DNA mutations to design enzymes , an enzyme engineering partner must possess robust AI-driven technology for computational hotspot identification , in silico enzyme library screening and in silico recombination leading to focused libraries of variants screened in high-throughput under process-related conditions . Some scientific and operational factors when considering potential enzyme engineering partners include :
• Capabilities : Are state-of-theart equipment and technologies being utilised in conjunction with a highly skilled scientific team ? Can the prospective organisation conduct projects within needed timelines at affordable costs , as well as manufacture engineered enzymes cost competitively and at all scales required throughout the product lifecycle , including commercial scale ?
• Approach : Is in silico investigation highly leveraged to streamline projects from both cost and timeline perspectives ? Does the prospective partner include reaction engineering in its enzyme engineering processes , including working as closely as possible under the commercial scale ’ s target process conditions ?
• Capacity : How many directed evolution projects can be performed in parallel ? What is the enzyme manufacturing scale and capacity ?
What are some important enzyme engineering IP , cost and service model considerations ?
Restrictive IP and the lack of service model flexibility among some enzyme engineering organisations have arguably slowed the adoption of biocatalysis . Catalytic route decisions are typically best made in the early stages of product and process development ; therefore , enzyme engineering must move in lockstep with the product development process . For instance , in the pharmaceutical industry , enzyme screening should be conducted in preclinical phases , and enzyme engineering should begin in Phase I . The enzyme ' s performance is increasingly optimised as the product makes its way to market and largescale production . Lack of IP flexibility and requiring significant investments before it is clear that a product will reach the market challenges the ability to incorporate biocatalysis early in the product development process . Changing transformation approaches in late phases of development is often not practically possible , particularly in highly regulated industries , resulting in missed opportunities to leverage the advantages of biocatalysts .
Flexible IP and service models coupled with scientific and manufacturing excellence enable innovation .
Enzymaster strives to contribute to a greener environment and improve manufacturing processes by helping organisations leverage the benefits of biocatalysts — decreasing dependence on toxic and often inefficient , purely chemical syntheses . Flexible fee-for-service models moving in lockstep with R & D programmes , high success rates , commitment to confidentiality , and the avoidance of one-size-fits-all IP policies allow Enzymaster to advance biocatalysis innovation rather than impede it , ultimately fuelling the future of manufacturing . •
Visit www . enzymaster . de for more information .
32 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981