November 16, 2022 PAO-11-022-CL-02
The development and approval of mRNA vaccines against the SARS-CoV-2 virus was truly a breakthrough in mRNA therapeutics, which had been explored for decades. Many mRNA-based vaccines and therapeutics are expected to address unmet medical needs in the near future beyond fighting SARS-CoV-2 virus and its variants.
As of summer 2021, over 1,800 clinical studies involving mRNA were listed in the U.S. National Library of Medicine database, approximately one quarter of which were in phase II.1 Nearly 60% of candidates target solid tumors, while 30% of candidates are vaccines. The remainder are treatments for diseases, such as colorectal cancer, Lyme disease, and autoimmune diseases. mRNA is also being investigated as a potential nonviral delivery system for gene therapies.2,3
In October 2021, a total of 49 mRNA prophylactic vaccine candidates were in clinical development.4 Many of these vaccines target infectious diseases that have to date eluded effective vaccine solutions, including malaria, influenza, and HIV/ AIDS. There are also significant efforts underway to develop a universal flu vaccine. Many cancer vaccines based on mRNA are also progressing through clinical phases, and there is a growing interest in the potential of mRNA-based cancer immunotherapies.5
mRNA-based vaccines and therapeutics are receiving considerable attention due to the following: the technology allows for the development of drugs and vaccines with very specific molecular designs and functionalities targeting many different types of disease mechanisms.6 The nature of mRNA machinery means that these medicines can target intracellular proteins, which have largely been considered to be untreatable using more traditional drugs.7 Moreover, they can be used to treat diseases caused by pathogens or that involve immune-related responses and disorders caused by missing or altered proteins by providing instructions to the patients’ cells to build the specific protein required.2 Since mRNA is produced using genetic sequence data, it is well suited for personalized medicines. Finally, mRNA-based drugs, unlike traditional ones, may help identify the underlying causes of diseases.1
mRNA technology could potentially broaden treatment options for many diseases and disorders that small molecule and biologic drugs are not able to tackle. With newer technologies like mRNA, there is no standardization across different CDMOs at this time, with each developing their own solutions, and nothing has yet been truly optimized. Developers of mRNA products therefore want to work with contract development and manufacturing organizations (CDMOs) that are true partners who are willing to take the time to understand each project and work together collaboratively to optimize and refine the development and manufacturing process.
The mRNA story has just begun. To cope with the rising demand for vaccines worldwide, the company proactively ventured to invest in expanding its mRNA vaccine production facility. The construction of an agile mRNA facility (in terms of scale and processes) began in the midst of the pandemic, operations started in April 2022. The new facility is located in the same campus as all other Samsung Biologics’ plants.
Samsung Biologics has built a cross-functional team dedicated to support mRNA services, including project management, manufacturing, quality, manufacturing science and technology (MSAT), and other activities, comprising experts from leading global companies in the mRNA field.
For COVID-19 mRNA vaccines in the market, production of mRNA drug substance, encapsulated (LNP) final product, and fill-finish activities have often been conducted at different sites, increasing the risk of contamination, time, and cost.
Samsung Biologics’ mRNA facility provides end-to-end solutions from pDNA linearization to fill-finish, all under one roof. The facility allows production from lab to commercial scale; from five to 200 liters.
Furthermore, the equipment needed to produce three different types of lipid nanoparticles has been installed and configured to seamlessly select the optimal formulation for drug delivery. There is also a dedicated process development laboratory for characterizing processes before scale-up.
For more than 11 years, Samsung Biologics has served as a trusted partner helping clients bring innovative medicines to patients’ bedsides. The company has a reputation for delivering within short timelines while providing high-quality products with customer-centric service, all achieved with right-the-first-time delivery.
Samsung Biologics is committed to supporting our clients in their mRNA journey to transform scientific promise into medical reality.
Esther (Seung-Yun) Yoo, Ph.D., is the Head of Development Sales at Samsung Biologics, where she leads the CDO, Small Plant (1 KL), and Platform Sales for mRNA. She has a breadth and depth of commercial experience in global and U.S. markets. Prior to joining Samsung Biologics, Esther held various roles at Gilead Sciences in Marketing, Strategic Pricing and Market Access Analytics, and Market Research. Esther received her Ph.D. in neuroscience at Baylor College of Medicine, followed by a postdoctoral fellowship at Harvard Medical School, where she was a recipient of the Autism Speaks Postdoctoral Fellowship Grant.