BioProcess Insider brings the biotechnology news as it breaks. For the on-demand BPI Theater at the Biotechnology Innovation Organization’s 2021 convention, founding editor Dan Stanton interviewed leading biopharmaceutical executives in early June
Contract development and manufacturing organizations (CDMOs) have thrived during the COVID-19 pandemic despite constraints on supply chains. Sam Machour, senior vice president and chief quality officer at Samsung Biologics explained that his company’s pandemic-period success has stemmed primarily from its ability to accelerate production timelines. Before 2020, technology transfers from drug sponsors required nine months or more. The pandemic necessitated solutions that could expedite the process without compromising drug-product safety and quality. By optimizing work and material flows from engineering, manufacturing, and quality perspectives, Samsung now can perform technology transfers within three months. That has enabled several drug sponsors to advance coronavirus-related therapies quickly in addition to supporting their existing products.
Samsung plans to accommodate more projects than it has before with the 2022 opening of its fourth facility in Incheon, South Korea. The “super plant” will raise this CDMO’s total stainless-steel bioreactor capacity to 640,000 L, making its campus the world’s largest site of biologics production. When asked about the possibility of building too much capacity, especially considering the future abatement of the pandemic and subsequent decrease in associated therapies, Machour responded that with 5,000 new biopharmaceuticals entering clinical trials each year, “There’s sufficient need for capacity, not just for the big companies, but also for the small and medium-sized companies that are doing a lot of research and development for biologics, vaccines, and cell and gene therapies.”
To support such companies, Samsung is augmenting its capabilities for advanced therapies and mRNA production, especially considering the latter’s promise for addressing a wide range of conditions. Machour added that his company is seeking out opportunities to establish manufacturing facilities in the United States and Europe to bring operations closer to its customers in those areas. Ultimately, Machour reflected, Samsung seeks to become a leading pharmaceutical company. Thus, it will continue to adapt its business models in ways that expand its manufacturing capabilities, extend its reach into biologics development, and bring novel therapies to patients.