Samsung Biologics Invests in mRNA Vaccine Production With New Applications on the Horizon


Contract development and manufacturing organization Samsung Biologics is investing in the future of mRNA vaccine production. After building a new end-to-end mRNA facility with drug substance and drug product capabilities, the CDMO is hoping to partner with developers of the next generation of therapeutics and vaccines for treating conditions such as cancer, heart disease, and HIV.

Moderna and Pfizer’s COVID-19 vaccines were the first mRNA vaccines approved for human use, but scientists and industry insiders expect that the innovations in mRNA spurred by the pandemic will have a positive long-term downstream impact on mRNA vaccine production for non-COVID applications.

“The market for mRNA is expected to grow steadily in coming years, primarily because mRNA can create therapeutics based on a novel mechanism of action (MoA) for applications that cannot be targeted by existing antibody platforms (e.g., gene editing, targeting of intracellular protein or pathogens, etc.),” wrote Samsung Biologics’ Pierre Catignol, executive vice president and head of manufacturing, and Huisub Lim, lead scientist in mRNA tech-transfer, in a recent white paper.

“MRNA technology also is conducive to highly specific molecular designs and functionalities, giving it the potential to achieve greater efficacy than traditional drugs by addressing the underlying causes of disease.”

GreenLight Biosciences Partnership

Samsung Biologics’ first use of its full end-to-end mRNA vaccine production capabilities is a partnership with GreenLight Biosciences to produce COVID-19 vaccines.

After partnering with Moderna to provide aseptic fill/finish services for COVID-19 vaccines in 2021, Samsung Biologics had experience in the drug product side of mRNA vaccine production. The GreenLight partnership demonstrated its expanded capabilities in mRNA drug substance production. The CDMO was able to produce 650 grams of mRNA at a titer of 12 grams per liter. This commercial-scale run was completed only seven months after the initial technology transfer from GreenLight.

“One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey Zarur in a statement following the completion of the partnership’s first run in August 2022. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.”

Non-COVID mRNA Vaccine Production

While it has demonstrated the effectiveness of end-to-end mRNA vaccine production for COVID-19 applications, Samsung Biologics’ long-term goal is to provide development and manufacturing services for a variety of mRNA products.

Vaccines that target cancer appear to be the next application on the horizon. A recent review found that advances in in vitro mRNA vaccine production technology, including lipid nanoparticle coatings and improved sequencing capabilities for DNA templates, have made mRNA cancer vaccines a viable possibility.

Personalized cancer vaccines could be sequenced according to the unique DNA of the patient to optimize effectiveness. Larger batches of vaccines that are more broadly designed to target malignant tumors are another possibility.

In addition to cancer treatments, there are mRNA pipelines devoted to infectious diseases such as influenza, HIV, and Zika, as well as respiratory ailments such as cystic fibrosis and several other conditions.

For Samsung Biologics, the key is to provide partners with the capabilities to produce vaccines at a variety of scales depending on the nature of the project. The CDMO is known for providing these capabilities in monoclonal antibody production, and the design of its mRNA vaccine production suite was aided by this experience, according to Catignol.

“We can produce from milligrams for preclinical and phase one, up to grams for clinical stage, up to hundreds of grams. That means phase three commercial scale in a [good manufacturing practice] manufacturing facility,” he said in a recent webinar on Samsung Biologics’ mRNA vaccine production process. “[Our] mRNA laboratory allows us to leverage our experience from the last 10 years in tech transfer process development and characterization. Mainly, all these competencies have been acquired for monoclonal antibodies.”

As mRNA technology improves and the regulatory environment adjusts to the post-COVID market, Samsung Biologics will be able to partner with both smaller and larger clients working on mRNA vaccines.

The investment in mRNA vaccine production is part of a broader portfolio diversification effort that John Rim, the CDMO’s president and CEO, explained recently at the 2023 J.P. Morgan Healthcare Conference. Rim explained that Samsung Biologics will also continue to invest in biosimilars after fully acquiring Samsung Bioepis in 2022, and he noted that the company is considering opportunities in antibody-drug conjugates and cell and gene therapies as well.

“The strategies outlined today will not only drive growth this year but also build sustainable foundations for the long term,” said Rim in a speech delivered at the conference’s main track in January. “We will continue to grow, ultimately to provide maximum satisfaction to our clients and to our investors.”