In the past two years, the world and the market have heavily focused on the advancement of medical technology. The global pandemic has emphasized the need for both preventative and therapeutic care for those exposed to the disease and need to be treated. Pharmaceutical companies and CDMOs had to overcome the many challenges presented during the pandemic, the supply chain shortages, the labor limitations, and the dangers of the virus itself. Meanwhile, they had to find new ways to expand and innovate to meet the demands of patients and populations everywhere.
CDMOs like Samsung Biologics created definitive plans to continue expanding and adding to their portfolio of services. Some of their major additions included the ability to provide fill-finish manufacturing services for the mRNA vaccine, a preventative medical invention that helps curb the fatal side effects of COVID-19 and hinder the spread of the contagious virus. Other services include a platform that helps partners accelerate the development and the regulatory approval for certain products.
Samsung Biologics is increasing its aseptic fill-finish capacity through various expansions, including flexible fill line, freeze dryers and pre-filled syringe line, all due to become operational within 2022 and 2023. These will aid drug manufacturing partners in meeting the strong demand for medicine and vaccines that is currently in place. With product approvals from several worldwide regulatory agencies over the course of five years, the GMP manufacturing services supplied by Samsung Biologics have established an exceptional track record.
Furthermore, Samsung Biologics is currently building a biomanufacturing facility at the Incheon Free Economic Zone that is set to be the largest in the world. CIO James Choi described the process, saying, “In automating our facilities, we utilize a Manufacturing Execution System (MES) at the beginning of each batch production to ensure that the materials are dispensed correctly and are accurately traced through the entire batch process, reducing the risk of operator error, and improving data accuracy with the automated weighing and dispensing process.”
The $2 Billion Super Plant Unveiled
“We scale up very quickly. Speed, in terms of our expertise, in terms of delivering quality to our clients and regulatory authority, it’s second to none,” CEO Jon Rim said in a recent interview. “When companies are taking four years, five years to build facilities, we can do that in two-and-a-half, three years.”
Samsung Biologics started constructing Plant 4, known as the “Super Plant,” in Incheon, South Korea, in November 2020, the city where the company’s headquarters are located. When completed, it will be the world’s biggest production facility for biopharmaceuticals, with a total building area of 238,000 square meters and a total manufacturing capacity of 256,000 liters.
“We need to provide fast, agile service to our clients so they can be fast to market,” Rim said. “We’ve actually reduced the speed to market for tech transfers for our clients quite rapidly. Historically, I think it was 6 to 9 months, now it’s 3 to 4 months.”
Samsung Biologics expects to possess one-fourth of the world’s total bio-CMO production capacity once Plant 4 is built and fully operating, with its Incheon headquarters providing a combined production capacity of 620,000 liters.
As a result of the plant’s modular architecture, it will be possible to convert some portions of the plant for many different purposes, improving the company’s ability to satisfy particular orders and partnership criteria. As well as various types of bioreactors, the factory has comprehensive CDO, CMO and bioanalytical testing service capabilities as well as an aseptic fill/finish capacity and a full internal QC lab to assure quality control for their own work as well as for their customers.
More Plans to Expand in the Future
Adding more technology addressed some of the challenges of the pandemic and also prepared Samsung Biologics to continue to provide CDMO services to their many partners. To give virtual tours while retaining high-definition images and dependable connectivity, in January 2020, the business launched the “Live Virtual Tour” technology. Inspectors were able to view what they needed to see to approve the procedure while maintaining the sterility and stillness of the medication production facilities via the use of virtual tours.
“Regulatory authorities can access the facilities, the documents,” Rim said. “We put that in place—a live virtual tour audit capability.”
Executive VP and Chief Information and Marketing Officer at Samsung Biologics James Choi introduced another new technological advancement. “In automating our facilities, we utilize a Manufacturing Execution System (MES) at the beginning of each batch production to ensure that the materials are dispensed correctly and manual entry is minimized to reduce the risk of operator errors,” he said. “Such automation not only improves data integrity but also enables the collection of data for broader analysis and optimization of our manufacturing processes.”