Given the arrival of SARS-CoV-2 vaccines, why do we still need therapeutics?
After more than a year into the COVID-19 pandemic, vaccines against the new coronavirus are all over the news. However, there is still a long way to go until people have been vaccinated worldwide, and as yet it is not clear how long the protection will last and whether the different vaccines will protect against re-infection and/or infection against mutated viruses.
Therefore, it is clear that even in 2021 and beyond millions of people will get infected by the virus and many thousands will become critically ill and require medical treatment.
Strategies for making SARS-CoV-2 therapeutics broadly available
Similar to vaccines, biopharmaceutical companies all over the world are trying to develop medications to combat Sars-CoV-2 infections: some are trying to repurpose existing drugs, others are developing small molecules or biologicals such as antibodies against a variety of targets – viral as well as cellular.
Evotec is also participating in this worldwide effort – but with a twist. The goal is to develop a monoclonal antibody that is not only effective, but can also be produced at low cost so that it is ideally suited to be administered even in the world’s poorest countries. And if all goes well, Evotec will also provide small, efficient manufacturing sites that can be operated all over the world.
Already in April last year, Evotec´s U.S. subsidiary Just - Evotec Biologics, Inc. entered into a partnership with Ology Bioservices, Inc. to evaluate and characterize antibodies against SARS-CoV-2. A few months later, in July, Just – Evotec Biologics was awarded up to $ 18.2 m by the U.S. Department of Defense for the development and manufacturing of monoclonal antibodies that might be able to prevent or treat COVID-19. And in September last year, the Bill & Melinda Gates Foundation joined in by granting another $1.9 million to develop and manufacture monoclonal antibodies at lowest possible cost of goods for the prevention of severe COVID-19 in vulnerable populations in low- and middle-income countries.
The concept of decentralised, affordable drug manufacturing
Just – acquired by Evotec in 2019 – was founded in 2015 in Seattle by former Amgen employees with the goal to make the entire manufacturing process of biotherapeutic drugs more efficient and affordable – not only by lowering development costs, but also by establishing smaller, more efficient manufacturing sites. The initial therapeutic focus was on anti-infectives, as infections constitute the biggest problems in poor countries that often don’t have enough money to purchase lifesaving drugs or to support their manufacturing, so lowering the costs of developing and producing anti-infectives are of great importance.
To accomplish this goal, Just is using artificial intelligence and an entirely data-driven drug discovery and development process. Its J.DESIGN technology platform integrates the discovery and optimization of drug candidates, process and product development, and manufacturing with the goal of providing a product that can be manufactured at low cost of goods. Using large, diverse data libraries and machine learning, the platform from the outset screens and designs biologics that can be developed and manufactured under the most favourable development conditions.
The know-how of the company comprises cell line development, upstream bioreactor design (fed-batch or continuous), and the development of downstream purification, analytical methods, final drug product, formulation, and long-term storage.
Just – Evotec Biologics also has developed a small, flexible, low-cost facility solution to biotherapeutics manufacturing called J.POD. This facility can be installed easily wherever production is needed.
As infectious diseases are on the rise across the globe and SARS-CoV-2 will unlikely be the last pandemic affecting the human population, the approach developed by Just - Evotec Biologics will become even more important in the future.
Interested in learning more?
Just- Evotec Biologics´ technologies and services are being offered to clients and partners interested in the fast and cost-effective development of biologics.