Amicogen, a specialized company in bio-pharmaceutical and healthcare materials (CEO Park Cheol), announced on the 9th that it has officially received the ‘ISO 9001’ and ‘ISO 13485’ certifications, recognizing its GMP-level quality management system. Through this certification acquisition, Amicogen has achieved a strict global standard in the development, manufacturing, and quality management of cell culture media (hereinafter referred to as media).
‘ISO 9001’ is an international standard that defines quality management systems and is the most renowned quality management system standard worldwide, obtained by over one million organizations in approximately 180 countries. Additionally, ‘ISO 13485’ is an international standard for medical device quality management systems, indicating that the organization meets more stringent regulatory requirements and has a system in place to ensure quality. By acquiring these certifications for media development, manufacturing, and quality management, Amicogen has been recognized for a quality management system that differentiates it from global competitors.
Amicogen introduced a rigorous quality assurance process at every stage from research and development (R&D) to production and supply chain management through the acquisition of ‘ISO 9001’ and ‘ISO 13485’ certifications and the application of ‘GMP Compliance.’ This system minimizes the critical risk of ‘Lot-to-Lot Variation’ in media manufacturing and guarantees consistency in manufacturing and quality. This means that Amicogen can meet the global pharmaceutical manufacturing standards required by its clients and actively support regulatory compliance.
The expertise of Amicogen’s Quality Management Office played a significant role in obtaining these certifications. The Quality Management Office is composed of personnel with extensive experience in various pharmaceutical companies and has a system capable of promptly responding to requests from domestic and global pharmaceutical companies. Notably, in 2021, when supply chain issues were prominent, Amicogen succeeded in supplying media materials for pharmaceutical manufacturing to a global German pharmaceutical company.
Son Changbin, head of the Quality Management Office, stated, “It is very meaningful to receive ‘ISO 13485’ certification for media, which is extremely rare,” and added, “This certification means that our company can provide safer and more reliable media tailored to the rapidly increasing demand in the pharmaceutical bio and medical device markets.”
He continued, “Having proven that we comply with international quality requirements through this certification, we will provide the highest quality media to customers worldwide and firmly establish ourselves as a global pharmaceutical bio materials company.”
Meanwhile, in March of this year, Amicogen secured the first large-scale media production facility in Korea, located in Songdo, Incheon. With an annual capacity of 106 tons, it can produce up to 300 tons or more. Amicogen has been continuously collaborating with domestic biopharmaceutical companies since 2020 to localize media and is currently in discussions with local pharmaceutical companies in the United States, India, and other global markets for market entry. Having completed all preparations for media supply, Amicogen is actively continuing its sales activities for supply in the second half of the year.
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