Companies in the biopharmaceutical industry must continue advancing, not just for the good of the company, but also for the safety, health, and security of doctors and patients around the world.
Leading CDMO Samsung Biologics has continued to focus on driving medical progress forward throughout the COVID-19 pandemic. They expanded facilities, forged new partnerships with other pharmaceutical companies who needed assistance and enhanced their already top-of-the-line process with new technologies. As more and more people have been vaccinated and the business world has slowly reopened, Samsung Biologics has moved towards becoming the world’s most reliable CDMO, at the service of researchers, pharmaceutical companies, and ultimately patients.
Introducing S-Cellerate
As part of its continued push to expand and improve, the company introduced its proprietary technology platform, S-CellerateTM, at the BioProcess International Conference in 2021 to offer clients and partners an integrated and seamless therapy and pharmaceutical development solution resulting in a more efficient and timely delivery.
S-CellerateTM is a drug development service platform that can expedite the process involved in the development and commercialization of monoclonal antibodies. Paired with S-Cellerate is an accelerated CDO timeline to an Investigational New Drug (IND) application, and a plan for commercialization so that a product can reach the Biologics License Applications (BLA).
According to the U.S. Federal Drug Administration (FDA), all drugs and treatments must have an approved marketing application before they are transported. Sponsors must first get exemptions, known as INDs, in order to ship their drugs to clinical investigators throughout the United States.
After the drug undergoes the IND and is found acceptable by clinical investigators, then Samsung Biologics moves onto the next process, the BLA. This is a request to introduce a biologic product into interstate commerce.
“We are very pleased to launch our innovative CDO service platform, S-CellerateTM,” said John Rim, CEO of Samsung Biologics. “By leveraging this proprietary drug development platform, our teams of experts will jointly provide seamless one-stop services to our clients, offering enhanced solutions that can help reduce both cost and time, catering to their specific needs.”
Other Technological Advancements
Samsung Biologics has not only kept up with medical advancements in technology, but also with other necessities that the pandemic brought forward. Thanks to the digitization of their facilities, Samsung Biologics was able to accomplish many tasks despite the logistical problems presented by the global pandemic, including an FDA inspection for the COVID-19 vaccine manufacturing facilities.
In January 2020, the company brought the “Live Virtual Tour” technology as part of their new process. This technology allowed the company to provide virtual tours and inspections while maintaining high-definition video images and stable internet connections. These virtual tours allowed the drug manufacturing facilities to remain sterile and still allowed inspectors to see what they needed to see to approve the process.
James Choi, SVP and Chief Information and Marketing Officer at Samsung Biologics, said, “One of the most important businesses for Samsung Biologics is a client firm’s inspection of our company’s factory. This is because the client firm has to check whether our quality process and manufacturing capacity meet their requirements. Inspections are important also for regulatory agencies, but COVID-19 made it difficult to do it.”
