Quality by Design (QbD) transforms biopharmaceutical development by prioritizing risk mitigation and quality throughout every part of a process. Originally pursued for medical devices, this proactive approach ensures consistent high-quality drugs and simplifies regulatory approval by managing variability and building robust processes, empowering developers to get drugs "right the first time."
One initial requisite for technology transfer is a detailed facility fit assessment and gap analysis, which considers the receiving site manufacturing capabilities, process controls, analytical requirements, material selection, and facility design.
Not all CDMOs are suitably equipped to handle aseptic processing and sterile F/F operations on a clinical and a commercial scale. Samsung Biologics excels by offering robust safety measures and global reach, driven by continuous investment in initiatives that facilitate high product quality at greater speed and with more process flexibility.
Samsung Biologics is a fully integrated, end-to-end CDMO service provider offering seamless development and manufacturing solutions from cell line development to final aseptic fill/finish for biologics. With commercialization in mind, we expand our development portfolio and continue to offer better service to fit clients' needs. Our facilities are cGMP compliant with bioreactor sizes ranging from small to large scale, enabling us to better serve the various needs of our clients and to meet growing biomanufacturing demands.
