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Fully Supporting Customer Needs for Biologics Development and Manufacturing

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Over the past seven years, Samsung BioLogics has constructed three state-of-the-art production facilities offering end-to-end integrated services to support the rapidly expanding clinical and commercial needs of customers. Building on successful FDA, EMA, and PDMA approvals in Plants 1 and 2, Samsung BioLogics increased capacity with Plant 3 (12 x 15,000 L bioreactors) and offered expansion of developmental capabilities, including Analytical Testing Lab, Process and Product Development, and Cell-Line Development Laboratory services to further support a growing customer base.

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.

Integrated Development Services – Clinical to Commercial

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).

 

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