#IndustryInsights: Why biocatalysis alone won't save the world! - LinkedIn

Biocatalysis in the production of small molecules for the chemical and the pharmaceutical industry has experienced a boom in recent years, and not without good reason. Biocatalysts, and enzymes in particular, can provide several advantages over traditional chemistry tools due to their high substrate specificity, bio-derived renewable feedstocks and environmentally benign reaction conditions.

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It comes as no surprise then that many VCs have invested heavily in this space. Considering its possibilities, it is compelling to think biocatalysis is the silver bullet we have long been waiting for. However, misinformation and misunderstanding has led to overconfidence. In order to avoid the burst of the next big bubble, it is of utmost importance to understand the limitations of biocatalysis.

Natural enzymes have evolved over billions of years to support the fitness of their host. In order to provide economically feasible applications in industry, enzymes frequently have to perform in higher substrate and product concentrations, tolerate organic solvents and/ or higher temperature conditions than exist in nature. More often than not, an enormous amount of effort is required to either identify a suitable enzyme in the natural world, or design an artificial one which fulfills the industrial production requirements for complex molecules.

Even in the case that the enzymatic reaction works very efficiently right from the beginning, the downstream processing can be really challenging and cost-intensive. You need to get the final product isolated, after all. Drug approval authorities have to be very strict when it comes to "peptide- or protein-related impurities", in particular in the final synthesis step of a drug substance.

Not to mention that the manufacturing of enzymes requires extremely costly fermentation processes which you can't compare with the production of small molecules. For these reasons, enzymatic catalysis usually only pays off for expensive target molecules or production on a laaarge scale.

For example, the bioproduction of the antimalaria drug Artemisinin took 10 years to develop and cost over $150 million. The research and development of a biocatalysed production method for 1,3-propandiol, a building block for polymers, took 15 years and cost over $200 million.

Although these examples didn't involve enzymatic but other biosynthetic routes, it shows how you can burn a lot of money when the technology isn't ready enough.

Investors need to take care when it comes to the KPIs of industrial biocatalytic production processes that some startups announce. If you read something such as "carbon negative" or "fermentation free", you should ask an expert in the field to have a closer look at it.

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Either the startup has found a scientific breakthrough discovery which you should directly invest in or they have just drawn the borders to calculate their KPIs so narrow that crucial parts are not taken into account. So far, I have only seen the latter.

In order to secure the intellectually property of expensive and time-consuming processes, investors usually request patent protection to prevent copycats. In the field of biocatalysed transformations, it is necessary to patent the particular enzyme which is defined by its sequence of amino acids. However, the specifications required by patent authorities have only gotten more and more strict over the decades. Nowadays, you need to accurately define a very large proportion of the exact amino acid sequence.

This makes the patent protection all but ineffective, since small adjustments to the sequence can easily circumvent the patent protection of enzymatic reactions without posing any drawbacks to catalytic performance.

In the case of very simple molecule structures, such as building blocks or starting materials, it becomes even easier to copy an enzymatic approach. If a startup advertises that they are manufacturing a specific simple small molecule with an enzymatic route, this public knowledge can actually work to their own detriment. This is because the mere awareness that a successful enzymatic pathway to a specific compound exists is often enough to inspire a copycat project. Knowledge of the exact enzymatic structure is not even needed. There is sufficient public domain knowledge available that can easily be exploited by people skilled in the art in order to develop a competitive enzymatic route within a relatively short timeframe.

The potentially high cost of new enzymatic processes, combined with the lack of any robust protection for intellectually property, thwarts the development of beneficial biocatalytic industrial transformations. That is, at least so long as investors don't understand the field.

As demonstrated, filing a patent can't be recommended as a sufficient IP protection strategy in this space anymore. Large enzyme manufacturers such as Codexis, Inc. have understood this for a long time. They have opted to simply keep their trade secrets. It is abundantly clear why they have found better success with this approach.