March 12, 2018 PAP-Q1-18-CL-016
The biopharmaceutical market continues to grow at a healthy pace, though intensive capital and expertise requirements often pose barriers to development. At Samsung BioLogics, we believe that a quality-driven contract development and manufacturing organization (CDMO) that is designed to be flexible and multi-product focused can operate more efficiently and cost-effectively than internal biopharmaceutical manufacturing organizations. Given the unified focus of a CDMO, Samsung BioLogics can maintain a high level of quality and compliance, while reducing the cost of new biologic drugs and accelerating their development and commercialization.
Given the dramatic success achieved in commercial-scale biologics manufacturing in just six years, Samsung has expanded services to include the production of non-clinical and clinical trial materials.
Customers can receive support for cell-line development, upstream/downstream process development and optimization, and analytical development. Leveraging new 50 L and 200 L bioreactors in the development lab and 2 x 1000 L bioreactors for clinical manufacturing, every step is geared toward developing a fully compliant and efficiently scaled-up manufacturing process to 15,000 L bioreactors. Samsung BioLogics’ experts use scientifically sound techniques and statistically meaningful analysis methods to reach optimal titer values and improved yields to fully support production of drug substances for use in clinical studies.
The development services complement existing capabilities in cGMP mammalian cell-culture manufacturing and downstream processing (centrifugation, depth filtration, chromatography, virus removal and ultrafiltration/diafiltration). Drug product services include aseptic fill and finish (lyophilization development, aseptic vial filling for liquid or lyophilized products) and full visual inspection and warehousing. Since Samsung BioLogics can produce both high-quality bulk drug substances and drug products in multi-product facilities located in Incheon, South Korea, customers receive truly integrated services while minimizing unnecessary costs.
Analytical capabilities include analytical method development, qualification/validation, comparability studies, release testing, and stability testing. For clients looking only for analytical support, Samsung BioLogics provides Standalone Analytical Testing services. Regulatory experts also provide support to clients throughout a project, including assistance with the filing of biologics license applications (BLAs).
In just seven years, Samsung developed world-leading single-site production capacity with the construction of three plants. Plant #1 began production in May 2011 with a capacity of 30,000 liters, followed by Plant #2 in September 2013, which added an additional 152,000 liters. Plant 2 was cGMP-ready for drug substance production as of February 2016. FDA and EMA approvals for production of its first monoclonal antibody were received in October and December 2017, respectively.
Groundbreaking for Plant #3, adding an additional 180,000-liter capacity, was held in November 2015. Construction of this facility — one of the world’s largest biological drug production facilities — was completed at the end of 2017. When this plant is cGMP ready in Q4 of 2018, Samsung BioLogics will have a total production capacity of 362,000 liters and will be the world’s largest biopharmaceutical CDMO.
With the completion of the third biomanufacturing facility, Samsung BioLogics has the ability to reliably supply large volumes of biologic APIs and formulated products to the global biopharmaceutical market at the most competitive cost. In six years, Samsung BioLogics has received 11 manufacturing approvals from regulatory authorities (US, Europe, Japan, and Korea) and won over 16 product manufacturing orders.
Samsung has earned a reputation for reliable, high-quality services. In 2017, the organization was recognized by Life Science Leader Magazine as a CMO Leadership Award winner for the fourth consecutive year, winning awards in all of the six core categories: overall quality, reliability, capabilities, expertise, compatibility, and development. Samsung BioLogics also received recognition at the Asia-Pacific Bioprocessing Excellence Awards 2017 in Singapore (in quality and manufacturing speed), and Best CMO in Korea Award 2017 and in 2018 “Best CMO to Watch Out For in 2018” by Korea & Company.
Samsung has rapidly built a strong track record in the biologic manufacturing industry on the foundation of world-class quality and compliance. At its core is a highly talented and committed workforce dedicated to client satisfaction and integrity. In its DNA is an insatiable focus on operational excellence in every aspect from process development, to tech transfer, to manufacturing execution. Ultimately, Samsung BioLogics understands that on the other side of every product it produces is a patient who is depending on the quality and efficacy of that product. At Samsung, we never lose sight of our responsibility to deliver for our clients and their patients.
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.