Due to the growing demand for vaccines and treatments, the medical and pharmaceutical industries have become more important than ever. Researchers must not only produce effective vaccines, but they must also be able to quickly manufacture and store high quality doses for those that need them.
Contract development and manufacturing organizations can step in to assist these companies to get these biologics to market faster and better. These CDMOs often have multiple facilities in key parts of the world that allow companies to prepare doses for the underserved communities that need to be vaccinated. But these CDMOs have also had to prepare and keep up with the ever changing technology and requirements to assist these pharmaceutical companies. The emphasis on quality, adaptability, and expansion has been crucial in ensuring effective doses of vaccines reach as many people as possible.
Leading CDMO Samsung Biologics prepared itself to step up and take on the challenges that came with such a mass production and distribution of the mRNA vaccine. The company was able to continually expand its capabilities to meet the requirements that came with a partnership with one of the leading creators of one of the world’s most effective mRNA vaccines: Moderna.
New Technologies and Capabilities
Samsung Biologics has already increased its business portfolio and manufacturing capacity to suit the industry’s rising demand as part of its long-term growth plan. From bulk drug substance to aseptic fill/finish, including labeling and packaging, as well as cold chain storage, the CDMO will be able to offer pharmaceutical companies full-cycle mRNA vaccine manufacturing services from its Songdo facility by the first half of 2022.
These additions are crucial. “We recently announced plans to add an mRNA drug substance suite to our site by the first half of 2022 to diversify our service offerings. We see great potential for mRNA technology to address a broader range of diseases, beyond COVID-19,” said Senior Vice President, Chief Information and Marketing Officer, and Head of Investor Relations James Choi in an interview.
As a first step to mRNA vaccine manufacturing, a biopharmaceutical company or CDMO generates the mRNA in a reactor through synthesizing linearized pDNA in an in-vitro transcription process. Then, the mRNA is purified for the formulation step using chromatography and ultrafiltration/diafiltration. In order to prevent degradation and allow in vivo distribution of the purified and filtered mRNA into Lipid Nanoparticles (LNP), precise pump mixing technology is used.
mRNA holds a lot of promise for medical research in the future. mRNA vaccines have been researched in the past for the flu, Zika virus, rabies and cytomegalovirus (CMV), and in the future, they may be able to give protection against several viruses and illnesses rather than just one. On the other hand, studies in cancer have taught mRNA how to stimulate the immune system to seek out and destroy malignant cells. Even during the COVID-19 pandemic, there has been an increased desire for innovative therapies for existing ailments as well as non-contagious diseases.
How mRNA Works to Fight COVID-19
One of the most recent medical advancements, the mRNA vaccine, may help limit the spread of infectious viruses like COVID-19. It has been shown to be successful in the fight against the virus, providing a means of prevention and reducing the severity of any outbreaks. Messenger RNA vaccines, according to the CDC, train cells to manufacture a protein, which results in an immunological response. Antibodies are produced by the immune response to keep the body from becoming infected with the virus.
In May 2021, Samsung Biologics signed a contract with Moderna, a biotech startup that has created an mRNA vaccine to stop the spread of COVID-19. One of the few Emergency Use Authorized mRNA vaccines available from Moderna has been shown to be effective in preventing death from the virus. More recently, the company has also entered into a drug substance manufacturing contract with Greenlight Biosciences for a promising new messenger RNA vaccine candidate to treat COVID-19..