Express Pharma

Biocatalysis: An essential tool for API synthesis

Naveen Kulkarni, CEO, Quantumzyme, explains how the area of biocatalysis is progressing quickly and the advantages it brings for the pharma industry

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The breakthrough research that won the 2018 Nobel Prize in Chemistry has evolved into a technology in itself. It refers to the fast development of enzymes to take up and catalyse the synthesis of unnatural substances into desired products. This process has various names, including biocatalysis, biotransformation and many others. Since then, it has grown to be the primary driver of green chemistry. Chemical and pharma manufacturers have made considerable use of biocatalysis to create various products, from speciality chemicals to fine chemicals. The commercial synthesis of chiral intermediates or the production of substances utilised to manufacture novel pharmaceuticals uses enzymes.

Biocatalysis is evolving into a transformative technology due to a convergence of elements such as large-scale and continuously increasing cost-effective DNA sequencing methods, exponential growth in GenBank, potent guided enzyme evolution, and high-throughput screening technologies. Furthermore, dependable expression methods for generating enzymes, a thorough understanding of natural product biosynthesis’s logic, and commercial successes with metabolic and pathway engineering. As a result, recent breakthroughs in biocatalysis for the pharma industry, including drug discovery, development and manufacture, have led to a variety of successful anecdotes and analyses.

The importance of biocatalysis

The use of organic materials such as enzymes or entire cells to accelerate chemical processes is known as biocatalysis. Due to its excellent regio-, enantio-, stereoselectivity and environmental friendliness, biocatalysis is regarded as one of the most potent techniques for organic synthesis. Biocatalysis, which employs enzymes for organic synthesis, has emerged as a powerful method for the development of Active Pharmaceutical Ingredients (APIs). It is now a tried-and-true approach for efficient, environmentally-friendly manufacturing, thanks to the recent development of a wide range of enabling technologies, particularly in the drug research sector.

Biocatalysis is now becoming the industry’s preferred solution since it simplifies complex chemistry and facilitates reactions at ambient conditions like temperature and pressure. Furthermore, it reduces manufacturing operating costs and removes the burden on the environment.

Advantages of using biocatalysis

Biocatalysts can be used to replace inorganic catalysts. When compared to traditional approaches, the biocatalysis process is both, environmentally friendly, and can be cost-effective. Biocatalysts form an integral part in assisting businesses to align with green chemistry efforts, as there is a growing interest in the Indian government’s Environmental, Social and Governance (ESG) goals. Furthermore, the technique improves enantioselectivity and stereoselectivity while requiring fewer synthetic steps and a faster development cycle. With an emphasis on green chemistry, the biocatalysis method aids in reducing organic solvent use and avoiding dangerous chemical reactions. Hence, we must minimise waste and pollution.

Challenges in biocatalysis

Although biocatalysts are frequently highly active and extremely selective, there are some limitations to using them as a general technique. For instance, enzyme evolution is an expensive and time-consuming process. Screening a large population of variants requires high throughput infrastructure that is not always available, particularly in the pharma industry, and is inaccessible to smaller biotech. Furthermore, biocatalysts’ lack of designability, stability restrictions and a shortage of well-characterised and ready-to-use biocatalysts have been impediments to speedier adoption.

Biocatalysis, like all applied sciences, relies on basic science for advancement. Despite the astounding developments in and around the subject of biocatalysis, it has been determined that a recurring and unresolved difficulty is making biocatalysis more predictive.

However, technological developments are resulting in beneficial trends and the development of computational methods to fill these gaps. India has the ability to play a major role due to several advantages like, being one of the key API suppliers in the global market with volumes that can easily justify the investment for even marginal improvement; leveraging the computational capabilities and R&D ecosystem created by major multinationals within India; support from government initiatives and startup ecosystem.

Partnership is the key to success

Although biocatalysis is widely acknowledged as a beneficial technology for producing greener and more sustainable industrial solutions, adoption has plateaued after progressively rising over the previous decades. One probable explanation is that breakthroughs in biocatalysis have surpassed current knowledge, leaving the pharma business uninformed of the enormous number of viable alternatives. Keeping up with current and upcoming biocatalysis advancements is, thus, crucial for preserving a competitive edge.

This requires multi-disciplinary skills ranging from molecular biology, chemistry and computational capabilities.

Hence, partnering becomes key to success in bringing together these various faculties of science and willingness by the large pharma and chemical industries to engage in R&D and examine the benefits of biocatalysis. In contrast, the API provider can provide a wide range of technical capabilities backed up by highly trained personnel and a track record of consistent quality and regulatory compliance. Thus, it should also take advantage of advances in biochemistry, molecular cloning, in-silico-driven enzyme engineering, immobilisation and fermentation technologies for the industrial production of APIs and intermediates by biocatalysis, improving the quality of the finished product.

Way forward

With the introduction of biological processes and continued breakthroughs in enzyme engineering, the area of biocatalysis is quickly progressing. Furthermore, newer structural approaches are expected to provide insights into enzyme catalysis. Investigating biocatalysis solutions in the early phases of the project development life cycle is a realistic operational strategy for producing the right product at the most incredible possible quality, and with exceptional efficiency. Exploring biocatalysis possibilities early in a project is a practical operational approach for achieving the correct output at the right rate and with excellent efficiency. Such an investment is not prohibitively expensive and may provide significant benefits such as cheaper costs, faster time to market and game-changing technical advantages for a sustained competitive edge.

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