29 October 2020 - Newsletter

Arriving at a coronavirus vaccine with enzymes

Enzyme manufacturer c-LEcta is one of the fastest-growing biotech firms in Germany and an important supplier to numerous makers of coronavirus vaccines. c-LEcta products are also used by worldwide pharmaceutical firms and food corporations.

In an interview, c-LEcta founder Dr. Marc Struhalla explains the role of the enzyme DENARASE® in the production of vaccines to combat the coronavirus.

Dr. Struhalla, biotechnology plays a central role in the production of vaccines, and not just since the outbreak of the coronavirus. How does c-LEcta help with vaccine production?

Dr. Marc Struhalla: We help the pharmaceutical industry make vaccines efficiently and safely. The production processes used to make vaccines generate unwanted by-products that need to be removed. Our DENARASE® product family serves precisely this purpose. The enzymes are used as process auxiliaries in the production of the vaccines, and we manufacture these products under the highest standards of quality. We also sell what is known as an ‘ELISA kit’ that can be used in quality assurance to demonstrate that enzymes added during production have been removed again in the subsequent purification process.

What is DENARASE®, and how does this artificial enzyme work? Why do vaccine manufacturers need your product? WhR other applications for DENARASE® are there?

DENARASE® is a nuclease – an enzyme that can systematically cleave nucleic acids such as DNA or RNA. These are released by the production host during vaccine production and must be quantitatively separated out during purification of the vaccines. Microorganisms or cell cultures are used for the production of biological vaccines. These contain a very large number of nucleic acids, which are the carriers of genetic information. DENARASE® is also used in drug production for the manufacture of biopharmaceuticals, particularly for use in gene therapy.

There has been a quantum leap in demand for DENARASE® in recent months. Is it possible to say that all of the relevant coronavirus vaccine projects all over the world work with your product? Do you expect a further rise in demand for DENARASE®, and can you easily respond to it?

There are more than 100 vaccine-development programmes under way worldwide to combat the novel coronavirus SARS-CoV-2, based on different principles. There are some projects in which it would not make sense to use DENARASE®. Our products are used particularly in vaccine programmes that work with viral vectors. We work with many pharmaceutical companies in this connection and have never had any difficulty meeting demand. We completed an extensive project to significantly expand our production capacities for the DENARASE® product family at the beginning of the year, so we were very well prepared for the increase in demand.

As a scientist, what is your assessment of the likelihood that we will have an effective vaccine against the coronavirus by mid-2021?

Given the multitude of programmes under way and the enormous effort on the part of the biotech and pharmaceutical sectors, I am very confident that several effective vaccines will be approved very soon, and that very high numbers of doses of vaccine will be available next year. Production operations are already being ramped up.

With the exception of the coronavirus, what are the main markets in which c-LEcta products are used?

In addition to DENARASE®, we also produce other enzymes that are used in the production of active ingredients for pharmaceuticals. In the field of cancer therapy, for example. In addition to the pharmaceutical industry, another major focus is on the food market. For example, we have developed a technology that can be used for high-efficiency production of a new kind of natural sweetener. The product has already been approved in many countries and has been on the market since 2018. This sweetener can be used to sweeten drinks and food without increasing the calorie content of the products.

Are there specific examples of food products in which you can say: ‘We’re part of that product’?

Our natural sweetener can already be found in numerous products that you can buy in the supermarket. Not yet in Europe, however, but in Southeast Asia and the USA. This is because we do not yet have an approval for the product yet in Europe; we are working on it, and unfortunately these processes always take a little longer in Europe than they do other countries. The products we’re part of include sweetener tablets for home use, dairy products such as yoghurts or drinks, and soft drinks.

Can you say anything about your product pipeline? What revenue potential do you see there?

We are currently working on around 15 projects to develop new products. These include enzyme products for use in the food and pharmaceutical sectors. But we also have another area of focus on ingredients. We are currently working to develop food additives, such as prebiotics or functional sugars, and on an ingredient with cosmetic applications. Our ambitious goal is to market at least one new product each year. The range of possible applications for the products in our development pipeline is very broad and totals to well over one billion euros.

c-LEcta has been an established and successful market player for more than 15 years. You founded the company in 2004 as a spin-off of the Leipzig University. That was a courageous step. Germany is not exactly known as an ideal breeding ground for innovative start-ups, although this may now change in the wake of the coronavirus. In your view, what is the main missing ingredient: Equity? Entrepreneurial spirit? An appetite for risk?

Perhaps a little of all of those. Our competitors in the US have received many times as much capital as we have. Nevertheless, this does not automatically lead to success stories, as venture capital involves high expected returns, and the funds must be put to extremely effective use as a result. A little German pragmatism and realism may come in handy here. On the other hand, firms then have to implement their big promising innovations worldwide, with full force. I think there is often a lack of consistency and ambition here, even on the entrepreneurial side. But we are well advised, particularly from a political point of view, if we continue to work to significantly improve the framework conditions for innovative start-ups in our country.

Herr Dr. Struhalla, thank you for speaking with us.