Samsung Biologics Successfully Completes Pilot Production of mRNA Vaccine Raw Materials

US Greenlight Develops COVID-19 Vaccine
Moderna Enables 'One-Stop Production' from DP to DS

Incheon Songdo Samsung Biologics Plant 3 (Photo by Samsung Biologics)

[Asia Economy Reporter Chunhee Lee] Samsung Biologics announced on the 2nd that it has completed the first engineering run of the active pharmaceutical ingredient (DS) for a COVID-19 messenger ribonucleic acid (mRNA) vaccine candidate. With this, Samsung Biologics has established a one-stop production system by not only contract manufacturing (CMO) the finished mRNA vaccine drug product (DP) for Moderna since last year but also setting up DS facilities.

This trial production follows the partnership agreement signed last November with the U.S. company GreenLight Biosciences for contract manufacturing of the COVID-19 vaccine candidate DS. GreenLight presented a vision in March last year to achieve global vaccine equity through the production of billions of doses of COVID-19 mRNA vaccines annually. After seven months of technology transfer and scale-up, the mRNA active pharmaceutical ingredient production facility was completed in May.

Subsequently, with the recent success of the first trial production, preparations have been completed to enable large-scale commercial production of the mRNA vaccine DS. Trial production is a process verification stage conducted just before full-scale commercial production, and success in trial production indicates excellent production capability at cGMP standards.

In this trial production, in vitro transcription (IVT) recorded a titer of over 12 grams per liter (ℓ), reaching the maximum range specified by the client. Titer quantifies the amount of antibodies in the culture medium. A higher titer means a greater amount of antibodies can be harvested.

The second trial production is scheduled for later this month, and Samsung Biologics plans to optimize the production process based on the results of the first trial production.

John Lim, CEO of Samsung Biologics

Andrey Zarur, CEO of GreenLight, said, “One of the most challenging tasks in producing high-quality pharmaceuticals is scaling up from small-scale to large-scale commercial production,” adding, “We express our gratitude to Samsung for their help and support in enabling large-scale production of the mRNA vaccine candidate to meet humanity’s COVID-19 vaccine demand.”

John Rim, CEO of Samsung Biologics, stated, “Samsung Biologics can now provide one-stop end-to-end services from raw materials to finished drug products not only in antibody pharmaceuticals but also in the mRNA field,” and added, “We will strive to supply mRNA vaccines and therapeutics developed in the future more rapidly through expanded services and production capacity.”

Meanwhile, Samsung Biologics is in discussions with potential clients for additional mRNA vaccine CMO contracts. From the 26th to 28th of last month, the company participated in the mRNA-Based Therapeutics Summit held in Boston, USA, where it presented its mRNA production capabilities and discussed orders and partnerships with various global pharmaceutical representatives.

This content was produced with the assistance of AI translation services.