The biopharmaceutical industry is evolving quickly. With innovations in areas such as mRNA vaccine production, antibody development, biosimilars, and artificial intelligence-based drug design, the industry looks to be entering a “new era,” according to a recent Newsweek report.
The report surveyed several executives at leading biopharmaceutical companies to get their take on which technologies would have the biggest impact in the coming years. For John Rim, CEO of contract development and manufacturing organization Samsung Biologics, the answer is nuanced. He plans to grow his company with a multidimensional strategy to remain an industry leader as biotechnologies improve.
“We are seeing a very positive momentum as the marketplace continues to grow, with [monoclonal antibody] therapies having a double-digit growth thanks to tech advancements and wealth increases across the globe,” said Rim. “From this perspective, the drugs that are more interventional and that help patients live longer are going to take off spectacularly in the following years. The biologics market will probably topple the small molecules one, but the whole evolution is closely linked to the popularization of new technologies.”
MRNA Vaccine Production
For Samsung Biologics, mRNA vaccine production is a key area of focus. The COVID-19 vaccines were the first mRNA vaccines approved and produced for human use, but experts anticipate that the technology will evolve to encompass several exciting new applications in the coming years. Potential applications range from vaccines for HIV and influenza, to personalized treatments for cancer and genetic diseases such as Huntington’s disease.
As of summer 2021, the U.S. National Library of Medicine Database listed more than 1,800 clinical studies involving mRNA. About 60% targeted solid state tumors, while 30% involved vaccines for various cancers and infectious diseases. Other candidates included treatment for Lyme disease and autoimmune conditions.
Samsung Biologics has prepared for the evolution of mRNA technology by building an end-to-end mRNA vaccine production facility. The facility enables the CDMO to produce mRNA, encapsulate it in lipid nanoparticles, purify it, and package it in a final drug product using aseptic fill/finish processes.
“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,” explained Samsung Biologics’ Esther Yoo, in a recent white paper. “Samsung Biologics’ mRNA facility provides end-to-end solutions from pDNA linearization to fill/finish, all under one roof.”
Antibodies and Personalized Medicine
In his interview, Rim said development of personalized medicines may take time, but that progress is being made. He also expressed optimism about the potential of AI to improve development time lines.
As AI technology evolves, more companies are using it to test the effectiveness of genetic therapeutics or antibodies, and to identify compounds that are similar to successful therapies but could improve their success rate or target more specific issues.
“It is true that mRNA vaccines were developed in record time, but clinical trials are still taking up to 10 years to be completed. AI might prove to be the answer to streamline those time lines,” said Rim. “Personalized medicine has been in the spotlight for quite some time, with antibodies being considered personal medicine options. But the shift towards completely individualized therapies will take time. Rather, we now have large categories of products with smaller subcategories that can be considered personalized options, such as CAR-T cell therapies and gene therapies in rare diseases.”
Samsung Biologics has developed an expertise in the manufacture of antibodies. It will provide an industry-leading biomanufacturing capacity of 604,000 liters once its fourth plant becomes fully operational in 2023. The company also has developed several new antibody platforms in recent years.
“We employ three major CDO technology platforms,” said Rim. “S-CHOice allows us to produce high cell line yields, S-DUAL is a bispecific platform, and DEVELOPICK enables us to identify the most efficient cell line.”
Sustainable Development and Samsung Biologics’ Future
As it prepares for this new era of biopharmaceutical development and manufacturing, Samsung Biologics is paying careful attention to the environmental impact of the industry. Rim noted that the healthcare industry accounts for about 4~5% of global carbon emissions. He emphasized the importance of intra-industry collaboration and partnerships with outside organizations and initiatives to strive for a future of net zero emissions.
“In order to address this subject we are actively engaged in the SMI — Sustainable Markets Initiative. Driven by King Charles III and led by CEOs and executives from various companies and national agencies (WHO, NHS, etc.), this program aims to set global standards and to create public and private partnerships,” said Rim.
In addition to the SMI, Samsung Biologics is involved with other initiatives such as the Carbon Disclosure Project, the Frontier 1.5D initiative, and the RE100. It has also established an environmental, social and governance committee and began releasing annual ESG reports documenting emissions targets and progress in 2021.
As it continues to invest in expanding capacity and new technologies such as mRNA vaccine production, Samsung Biologics wants to ensure that the new era of biopharmaceuticals is a sustainable one.