Biologics' 3rd plant wins ISO 22301
Samsung Biologics CEO Kim Tae-han, left, shakes hands with BSI executive Song Kyung-soo, center, after the company's third factory in Songdo, Incheon, received ISO 22301 certification, Tuesday. Courtesy of Samsung Biologics
By Kim Yoo-chul
Samsung Biologics, a leading biological drug development company, said Tuesday its third manufacturing plant in Songdo, Incheon, has received ISO 22301 certification.
The latest achievement marked the company's three factories being recognized as facilities that can guarantee the stable supply of its products with greater acknowledgement of the firm's qualified and advanced handling of bio-safety testing services, Samsung Biologics said.
Samsung Biologic's last received ISO 22301 certification from the British Standards Institution (BSI), a global certification association, in April 2018. ISO 22301 certificate is well regarded as a comprehensive industry standard published by the International Organization for Standardization (ISO), which represents the highest level of commitment of business continuity and disaster preparedness.
Samsung Bio's third Songdo factory has an annual production capacity of 180,000 liters. One of the key features inside the facility is the application of advanced “N-1 Perfusion” technology to manufacture bio products. Spokesman Seo Hae-su said the company's small contract manufacturing organization and bio-safety testing service laboratory had been under review.
Seo said the company has been testing and assessing various possible risk factors that may affect the company's manufacturing operation in the worst case scenario since last year. A total of 39 experts from 32 divisions were assigned to address all expected shortfalls.
In the case of biopharmaceuticals, stable production and supply of products are directly related and linked to the progress of disease improvement; therefore, the accurate and stable delivery of bio products are regarded as the core factor to gauge the sustainability of bio drug manufacturers.
“Through the ISO 22301 certificate, Samsung's quality management ability will be recognized once again and it will be a great help in securing additional orders,” its CEO Kim Tae-han said in a statement relayed by the company. “Samsung will continue to identify internal and external risks and improve our processes so that we will become a company that leads global standards for crisis response by providing our customers with high service availability and business continuity.”