Merck and Baylor College of Medicine Expand Collaboration to Advance COVID-19 Vaccine Manufacturing Platform
Merck Group
Pharmaceutical R&D Developer
Baylor College of Medicine
Baylor College of Medicine is a private medical school in the United States, regarded as one of the most prestigious medical schools in the nation. Located in Houston, Texas, it is situated within the renowned Texas Medical Center. Baylor College of Medicine is among the few institutions in the U.S. with an endowment exceeding $1 billion. In the U.S. News & World Report rankings of U.S. medical schools, Baylor ranks 10th in research, 11th in primary care, and 22nd in its graduate programs.
Darmstadt, Germany, May 27, 2020 /PRNewswire/ -- Leading science and technology company Merck KGaA and Baylor College of Medicine in Houston, Texas, USA (Baylor College of Medicine) announced today the further expansion of their ongoing collaboration to advance the COVID-19 vaccine manufacturing platform, aiming to accelerate entry into Phase I clinical trials.
Wu Boda, Member of the Executive Board of Merck KGaA and CEO of the Life Science Business SectorUdit Batra) stated: “Vaccine manufacturing is extremely complex, so we are collaborating to develop a process approach to accelerate the production of Baylor’s COVID-19 vaccine candidate. To combat this pandemic, we need to produce an unprecedented quantity of vaccines in a very short time, and we require as many approaches as possible to ensure success.”
Given the high complexity and diversity of vaccine manufacturing methods, there is no standard manufacturing template or process, making vaccine production a key challenge for each institution competing to develop safe and effective COVID-19 vaccines. Merck has collaborated with researchers from Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine Development to optimize production processes and advance the manufacturing of two COVID-19 vaccine candidates, including CoV RBD219-N1, which is expected to enter clinical trials later this year. This collaboration leverages key insights from their ongoing schistosomiasis vaccine partnership. Merck will help accelerate the scale-up of sustainable large-scale manufacturing. The partnership will focus on improving production efficiency, yield, robustness, scalability, and cost-effectiveness.
Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine and Co-Director of the Center for Vaccine Development at Texas Children's Hospital (Peter Hotez) Dr. and Maria Elena Bottazzi (Maria Elena Bottazzi) Dr. said: “Our initial collaboration with Merck has established a critical framework that enables us to rapidly validate and prepare for the global production of vaccines against neglected tropical diseases.”
Peter Bottazzi, Associate Dean of the National School of Tropical Medicine at Baylor College of Medicine and head of product development activities, stated: “Expanding our collaboration, including in the area of pandemic diseases, will now enable us to accelerate the development of scalable and affordable manufacturing processes for COVID-19 vaccine candidates, thereby facilitating the rapid support of vaccine production in low- and middle-income countries.”
The Merck-Baylor team will improve the manufacturing platform for the CoV RBD219-N1 candidate vaccine, which was initially developed from 2011 to 2016 with the aim of treating SARS. In addition, they will develop a manufacturing platform for a second COVID-19 candidate vaccine to shorten the time required to enter Phase I clinical trials. The goal of this collaboration is to develop suitable manufacturing processes and steps, thereby creating scale-up methods applicable to pilot production and subsequent industrial-scale manufacturing.
Merck process development scientists and biomanufacturing engineers, along with researchers at the Texas Children’s Hospital Center for Vaccine Development, first established a collaborative partnership in 2018 to advance vaccine development and manufacturing and strengthen responses to outbreaks such as COVID-19. Leveraging the preliminary foundation laid through efforts on existing process development platforms, the team was able to rapidly shorten the timeline for bringing vaccines into clinical trials, thereby achieving a key objective.
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Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine Development have received funding from NIAID for the early-stage development of the CoV RBD219-N1 candidate vaccine, as well as the initial development of a second COVID-19 candidate vaccine. Furthermore, Baylor and the Texas Children’s Hospital Center for Vaccine Development aim to advance the development of COVID-19 candidate vaccines through their partnership with PATH, supporting vaccine deployment in low- and middle-income countries.