Samsung BioLogics is well on its way to becoming the world's largest contract manufacturer. Getting to the top will give Samsung BioLogics more than just status. With 362,000 liters of capacity, the company will be uniquely well placed to respond quickly to the development and manufacturing needs of its clients, thereby helping them get drugs to patients faster.
The capacity has tangible implications for Samsung BioLogics’ customers. While rising demand for biologics production services has caused capacity constraints at some contract development and manufacturing organizations (CDMOs), limiting their ability to take on new projects, Samsung BioLogics is ready to welcome companies that need a development and manufacturing partner.
Companies that choose Samsung BioLogics as their CDMO partner will ensure manufacturing never slows the progress of their programs. As per FDA recommendations, Samsung Biologics is ready and able to be part of a “dual source” supply of biologics products. The FDA recommends this approach to ensure continuous supply and eliminate the risk of a regulatory delay at one plant setting back the whole schedule.
Samsung BioLogics’ readiness to take on new work stems from the additional capacity it is bringing online. Having established a 182,000 liter footprint with its first two facilities, the CDMO is now set to nearly double its capacity by opening the world’s largest biologics production plant. The plant’s first contract, which is worth up to $150 million, is already signed.
The size of the plant means Samsung BioLogics can onboard new projects immediately but that is not the only way it will benefit customers. Samsung BioLogics has also adopted cell growth technology N-1 perfusion, a design that permits continuous operation and a cleaning regime tailored to rapid changeovers. These decisions have cut costs, risks and time and batch losses when switching between products, while increasing uptime, giving the plant sector-leading agility and efficiency.
Samsung BioLogics made these design choices in the service of client satisfaction. The CDMO passes savings along to its customers, helping them to reduce the cost of drug development and production, and its focus on scale and agility means capacity is available as needed.
This approach continues the client-focused model Samsung BioLogics has followed since it started life in 2011. In following the model, the CDMO has shown a rare willingness to adapt its operation to the needs of clients and created an experienced team dedicated to getting the critical, early tech transfer step right. The merits of this approach for clients have been recognized across the industry, resulting in Samsung BioLogics winning CMO Leadership Awards in all six categories in 2017 and 2018.
Building on a track record of client-focused excellence
The construction of Plant #3, Samsung BioLogics’ most ambitious plant yet, is testament to the firm’s commitment to continuous improvement. Bringing the plant online will take the CDMO to another level in terms of capacity, competitiveness and ability to maximize client satisfaction. But it was Plant #1 and Plant #2 that landed Samsung BioLogics contracts with companies including Bristol-Myers Squibb and Roche and established its reputation as a client-focused CDMO.
The success of the first two plants serves as a guide for how Plant #3 will benefit clients. In setting up the plants, Samsung BioLogics drew on its experience of building and operating 25 semiconductor sites and more than 50 petrochemical facilities to redefine the time and cost needed to create biologics factories.
Plant #2 is a commercial-scale facility that features 10, 15,000 liter bioreactors and two, 1,000 liter bioreactors. Samsung Biologics spent 17 months building the plant and a further 12 months on validation. Nineteen months after starting engineering runs, the FDA approved the plant, enhancing the satisfaction of Samsung Biologics’ clients. The whole process took far less time than is typical in the sector, enabling Samsung BioLogics to significantly reduce its capital expenditure and further enhance client satisfaction.
In keeping with Samsung Biologics’ client-focused model, the firm’s customers are the beneficiaries of the savings. Building sector-leading plants while spending far less than the CDMO industry average has enabled Samsung BioLogics to provide high-quality manufacturing services at a more competitive price. To ensure the foundation provided by the plants translates into an industry-leading service, Samsung Biologics has paired it with an experienced team focused squarely on client satisfaction.
The cost, quality and speed offered by Samsung Biologics has redefined the CDMO sector, giving companies ready access to affordable capacity and cutting the time and money needed to bring breakthrough drugs to patients.
Plant #3 will continue and expand this way of working. The specifics of the plant are different but the culture remains the same. Any success Samsung Biologics enjoys in the future will be built on the same foundation that got it this far: the dedication of employees focused on satisfying clients today, and finding ways to do even better tomorrow.
Samsung BioLogics is a fully integrated CDMO with the largest capacity in the world. We provide development and manufacturing services for biopharmaceutical companies of any size. We are here to deliver superior client satisfaction through execution excellence and innovation. We received CMO leadership awards in all six categories for two consecutive years.