The late 2010s were a turning point in the development of mRNA vaccines. This was after years of intensive research. There was still no approved mRNA vaccin or any attempts to produce large quantities of mRNA vaccines.
With the COVID-19 epidemic, this changed. Because mRNA vaccines are easier to develop and edit than conventional vaccines, they were well-equipped for meeting the challenges of producing COVID-19 vaccines in the fast timeframe required by global pandemics.
Moderna and Pfizer’s COVID-19 vaccines were the first mRNA vaccines approved for human use, and the scale of the pandemic meant that these vaccines had to reach millions of people around the world. Moderna turned towards Samsung Biologics to meet this unmet demand. contract development and manufacturing organization (CDMO)To help make its vaccines.
Moderna’s vaccine was supplied by the CDMO for aseptic fill/finish, labeling and packaging. Samsung Biologics is now able to produce active substances in mRNA vaccinations, as well as transfer this substance into the final vaccine.
“Following the successful start of our mRNA vaccine fill/finish manufacturing last year, Samsung Biologics is adding an mRNA drug substance manufacturing facility,” said John Rim, Samsung Biologics president and CEO, in a March 2022 letter to shareholders. Rim explained that the addition of the facility means that Samsung Biologics can now offer “a true end-to-end manufacturing service for mRNA vaccines and therapeutics.”
How Does mRNA Vaccines Production Differ From Traditional Vaccine Production?
To stimulate the immune response, traditional vaccines inject a tiny amount of target virus. In contrast to traditional vaccines that inject a small amount of a target virus into the bloodstream, mRNA vaccinations deliver genetic material directly to the cells. This genetic material (mRNA) is intended to teach cells how to make specific proteins to combat the target virus.
The traditional method of producing a virus from mammalian cells or eggs in a laboratory to create a vaccine takes several months. However, mRNA vaccine manufacturing is cell-free and can be performed much more quickly than other vaccine production processes. The process involves creating DNA sequences, which can then be edited electronically and shared to communicate any necessary modifications.
Samsung Biologics’ mRNA Vaccine Production Capabilities
Samsung Biologics has completed the construction of its drug substance facility. This will allow it to provide drug substance as well as drug product services at its Songdo headquarters.
Services related to drug substance use developing the mRNA used in vaccinesDrug product services include the production of a vaccine product. This involves transferring the virus to vials, labeling and packing, as well as cold chain storage.
Beginning with the creation of the vaccine drug substance, mRNA vaccine production begins. The first step in plasmid DNA production is to make it linearized. This means that an irregular DNA molecule can be cut into a straight molecule. The process uses enzymes and nucleotides, to create a molecule which can be transscribed or capped. This is where genetic information in DNA can be transcribed into mRNA molecules that can then transfer the information to cells for production of proteins.
This mRNA is synthesized in an reactor. Then it’s purified through chromatography and diafiltration. The mRNA can now be sealed with lipid nanoparticles. These fatty molecules prevent the degradation of the mRNA, and allow it to be delivered via vaccine.
Once this drug substance is produced, it’s transferred to vials through an aseptic fill/finish process. Fill/finish refers to the process of transferring a sterile drug to a sterile container — a vial, in the case of mRNA vaccine production. The process is aseptic in that it’s designed to prevent any contamination that could compromise the mRNA drug substance. Samsung Biologics employs exact filling, dispensing, sealing, and monitoring temperature around the clock to protect against contamination.
For mRNA to be safe, they must be stored at the right temperature. Samsung Biologics has walk-in and upright storage units that can withstand temperatures down to minus 70 C. This ensures these conditions are maintained.
Samsung Biologics – The Future for mRNA Vaccines
The first mRNA vaccine production project to utilize Samsung Biologics’ new end-to-end capabilities is the manufacture of a COVID-19 mRNA vaccine candidate for GreenLight Biosciences. The production of the vaccines started in May 2022.
Rim said in a statement that GreenLight was delighted to announce the partnership. Samsung Biologics is proud to announce this collaboration. The expanded capabilities will allow us to produce mRNA from drug substance through aseptic fill/finish and commercial release from one site. We will work to provide seamless services across our biomanufacturing networks in this moment of global urgent demand. This will help us fight the COVID pandemic, and, ultimately, make Korea’s goal of becoming a vaccine hub.
While Samsung Biologics and the biopharmaceutical industry as a whole have focused on mRNA’s applications for COVID-19 vaccines in recent years, ongoing research is pursuing several other potentially viable applications for mRNA technology, including fighting cancer and infectious diseases such influenza, rabies, and Zika virus.
Samsung Biologics’ expanded mRNA vaccine production capabilities enable the CDMO to continue to play a role in this innovative space as it evolves.