SelectScience
Join Free
Accelerating Science
NewsClinical Diagnostics

Joining forces against SARS-CoV-2: Rentschler Biopharma contributes to manufacturing of COVID-19 mRNA vaccine

Rentschler Biotechnologie GmbH

Rentschler Biopharma to provide cGMP manufacturing services for mRNA-based vaccine candidate, developed by BioNTech and Pfizer against SARS-CoV-2

8 Oct 2020
Tom Casburn
Associate Editor

Industry news

Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, has announced an agreement to serve as CDMO partner for BioNTech. As an initial project, Rentschler Biopharma will be responsible for key aspects of cGMP (current good manufacturing practice) drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech, and is currently in a global Phase 3 clinical trial.

Under the agreement, Rentschler Biopharma will be responsible for downstream processing to provide highly purified drug substances. Process and product-related impurities will be effectively removed from the intermediate pool, which has been previously derived from mRNA synthesis. This is an important step in ensuring the safety and tolerability of a vaccine for use in humans, while at the same time maximizing the amount of mRNA harvested from the initial production process. Rentschler Biopharma will produce purified drug substances at its headquarters in Laupheim, Germany.

Dr. Frank Mathias, CEO of Rentschler Biopharma, said: “We are honored to contribute to BioNTech’s ‘Project Lightspeed’ and their work in developing this highly innovative mRNA vaccine. To tackle the COVID-19 pandemic, it is critical to bring high-quality, safe and effective vaccines to the public quickly and on a large scale. At Rentschler Biopharma, we feel it is important to do our part in combatting this virus. As a cGMP service provider with more than 40 years of proven manufacturing expertise, we are well suited to work with BioNTech to make their ground-breaking science a medical reality and will work tirelessly to this end.”

BioNTech and Rentschler Biopharma will use an innovative business model that is well suited for novel, urgently needed technologies and allows maximum flexibility to address BioNTech’s development and manufacturing requirements. In addition to large-scale production services for the COVID-19 vaccine, the agreement also provides for small-batch manufacturing of BioNTech’s other RNA programs for use in clinical trials.

Federico Pollano, SVP Global Business Development of Rentschler Biopharma, added: “We are excited to have the opportunity to work with BioNTech on this urgent project, as well as over the long term. A critical success factor in all the projects we take on at Rentschler Biopharma is close collaboration with our clients. Working in partnership with BioNTech, we determined that the best way to address their COVID-19 vaccine drug substance manufacturing needs was to establish a dedicated mRNA production suite for them in our Laupheim facility. This approach ensures capacity, staff and equipment are ready when needed without interruption of other ongoing projects at our site. It is also an approach that is quickly and easily scalable to meet future demands.”

For more of the latest science news, straight to your inbox, become a member of SelectScience for free today>>

Links

Rentschler Biotechnologie GmbHCompany website

Tags

ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.RNARNA is a nucleic acid that plays a key role in gene expression and protein synthesis. It serves as a messenger between DNA and ribosomes, carrying genetic instructions to produce proteins. Advances in RNA-based therapies, such as mRNA vaccines and gene editing, have revolutionized treatment strategies for genetic disorders and infectious diseases. Explore RNA research tools and therapies in our peer-reviewed product directory; compare products, check customer reviews, and get pricing directly from manufacturers.Vaccine DevelopmentVaccine development focuses on creating immunizations to protect against infectious diseases. The process involves identifying antigens, developing and testing vaccine efficacy, and ensuring safety through preclinical testing and multiple clinical trial phases. Scientists use various approaches, including weakened or inactivated viruses, protein subunits, or mRNA. Advanced platforms and rapid diagnostic tools aid in vaccine research and testing. Explore vaccine development solutions in our peer-reviewed product directory; compare products, read reviews, and get pricing directly from manufacturers. CoronavirusCoronaviruses are a large family of viruses that can cause illnesses ranging from the common cold to more severe diseases like COVID-19. Research into the biology, transmission, and treatment of coronaviruses has become a global priority, particularly since the emergence of SARS-CoV-2. Understanding the virus�s structure and behavior is essential for developing vaccines, diagnostics, and antiviral treatments. Explore our peer-reviewed product directory to discover the latest research tools, diagnostic tests, vaccines, and treatments for coronavirus, compare products, read reviews, and receive pricing directly from manufacturers.Covid-19COVID-19, caused by the SARS-CoV-2 virus, has led to a global health crisis with profound impacts on societies and economies. Research into diagnostics, vaccines, treatments, and understanding viral mechanisms continues to evolve. The pandemic has accelerated innovations in healthcare and biopharmaceuticals, including novel vaccine platforms and rapid testing technologies. Browse our peer-reviewed product directory to find top COVID-19 testing kits, research tools, vaccines, and treatments, compare products, read reviews, and receive direct pricing from manufacturers.

Related articles

Joining forces against SARS-CoV-2: Rentschler Biopharma contributes to manufacturing of COVID-19 mRNA vaccine