In his annual letter to shareholders in 2022, John Rim, the CEO of contract development and manufacturing organization (CDMO) Samsung Biologics, laid out a “multidimensional growth plan” for the company as it entered its second decade of operations.
The plan consisted of three pillars: expanding manufacturing capacity, diversifying the company’s portfolio, and increasing its global footprint. When it came to portfolio diversification in 2022, mRNA vaccine production played a key role for Samsung Biologics, as it added a new end-to-end mRNA suite. Now, the CDMO is looking to build on this established mRNA foundation in 2023.
“We have mRNA-dedicated teams and experts to answer all your questions and take care of your product,” said Pierre Catignol, executive vice president and head of manufacturing at Samsung Biologics, in a recent webcast on the CDMO’s mRNA capabilities. “We have a full scope of services, and we have all flexible scales from laboratory to commercial we can tailor according to your needs.”
Samsung Biologics’ mRNA Vaccine Production Capabilities
In committing to expanding its mRNA vaccine production capabilities, Samsung Biologics is betting on a trend of continued innovation in this rapidly growing segment of the biopharmaceutical industry.
After years of research and development into viable mRNA vaccines, the technology reached a breakthrough in recent years with the introduction of lipid nanoparticle coatings, fatty molecules that encase mRNA to prevent degradation. This breakthrough in LNP technology coincided with an unprecedented demand for vaccines due to the onset of the COVID-19 pandemic.
mRNA vaccines differ from traditional vaccines in that they use genetic messages to instruct the body to create disease-fighting proteins rather than trigger an immune response by introducing an antigen into the body. These easy-to-edit vaccines, which don’t require a virus to be grown in living cells and thus can be rapidly produced and adjusted to respond to mutating viruses, were ideally suited to combat COVID-19.
Moderna and Pfizer were both able to produce successful COVID-19 mRNA vaccines that were approved at an unprecedented rate as the pharmaceutical industry and regulatory officials ramped up collaborative efforts to fast-track a vaccine without sacrificing quality or safety.
Samsung Biologics provided fill/finish services for Moderna’s vaccine, transferring the mRNA drug substance into vials through an aseptic process that ensured a lack of contamination, then labeling and packaging the finished vaccine product.
In 2022, Samsung Biologics decided to build on this experience, expanding its capabilities to include drug substance development in addition to its existing drug product capabilities. This meant developing a suite capable of linearizing circular plasmid DNA, transcribing the DNA into mRNA molecules, then purifying the mRNA using enzymes and nucleotides and encapsulating it in LNPs. Samsung Biologics also designed its new suite to produce the LNPs in-house.
Catignol explained the advantages of this approach in a recent white paper.
“Frequent handling of mRNA in multiple locations increases contamination and degradation risks, but when the entire work stream from pDNA to vial is coordinated by one partner from a single location, transitions across development and production tasks run smoothly, maximizing efficiency, and eliminating these potential risks,” wrote Catignol. “Samsung Biologics offers integrated manufacturing services from clinical to commercial, including aseptic fill/finish, labeling, packaging, and cold chain storage — all at a single site — to successfully manufacture mRNA therapeutics.”
Demonstrating mRNA Success
Samsung Biologics’ first demonstrated use case of its expanded mRNA vaccine production capabilities came in July 2022, when it completed the first commercial scale production run of Boston-based GreenLight Biosciences’ mRNA COVID-19 vaccine.
The run produced 650 grams of mRNA at a titer of 12 grams per liter and was completed just seven months after the initial technology transfer. In the webcast, Dr. Eunseo Lee, a senior specialist in mRNA and LNP development at Samsung Biologics, explained that this titer is comparable to a small-scale production run despite the large amount of mRNA produced, demonstrating the efficiency of Samsung Biologics’ end-to-end approach.
“This titer was comparable to a small-scale production. When you also look at two critical quality attributes of LNP size and mRNA encapsulation percentage, you see that the results from small and large scales are comparable as well,” said Lee. “In this case, mRNA synthesis and LNP formulations were achieved without the need for customization using the standard equipment for an mRNA CDMO.”
While there was no need for customization in GreenLight’s case, one of the advantages of Samsung Biologics’ in-house approach is the capability to handle both larger scale projects such as GreenLight’s and smaller-scale projects.
“To support all of this full scope, we have on-site in Korea a [Manufacturing Science and Technology] lab with various related equipment at small scale, from 100 milliliter up to 10 liter, and we have a [good manufacturing practice] manufacturing facility [that is] large scale with all related equipment. In this facility, we can produce up to 200-liter scale batches,” said Catignol.
Catignol also highlighted the CDMO’s experience accommodating a variety of tech transfer and production process needs as a leading provider of monoclonal antibodies for over a decade. Samsung Biologics’ approach to mRNA vaccine production reflects its general strategy of providing a one-stop shop for services with the capability to adapt to a variety of scales and unique partner needs. This approach enables the CDMO to work with partners ranging from the largest pharmaceutical companies to smaller developers — and to provide biologics at both laboratory and commercial scales.
Looking Forward to 2023
The adaptability of Samsung Biologics’ platform could position it as a leader in the nascent field of mRNA vaccine production at a time when more and more pharmaceutical companies are outsourcing services to CDMOs.
“Twelve of the Top 20 global pharma companies, as well as many smaller players, currently partner with Samsung Biologics because of our ability to ensure security of supply, as well as because of the quality, speed, and cost of our offering,” said Rim in a recent interview with Pharma Boardroom.
“In the past, pharma companies looked at [contract manufacturing organizations] partnerships and dual sourcing primarily as a risk mitigation exercise,” he continued. “However, pharma is now realizing that its core competencies are in [research and development] rather than in building and maintaining manufacturing facilities, leading to a greater degree of outsourcing. I foresee that trend continuing, particularly in an environment of constrained supply chains post-COVID.”
Samsung Biologics also continues to increase its capabilities on the development side to support future growth of its mRNA and monoclonal antibody businesses.
“Samsung Biologics recently invested $50 million on a drug delivery platform,” said Lee, noting that the platform involves “molecular profiling and advanced analytics on natural nanoparticles and information molecules. This will lay the groundwork for establishing a platform of mRNA technology and expand the service scale as a CDMO company.”
