In China we are proud to have supported Yucan Bio in achieving China’s first US FDA approval for a serum-free culture medium for mesenchymal stem cells (MSCs). This marks only the second approval of its kind worldwide (510(k) No. K232543) and highlights the growing global shift toward safer, more standardized cell therapy solutions.
Serum-free media offer clear advantages over traditional formulations. With no components of human or animal origin and a defined composition, they significantly reduce risks tied to allergens, pathogens and unknown biological contaminants. As a result, they are becoming the platform of choice for pharmaceutical companies seeking safer, more reliable solutions for stem cell research and clinical application.
We help clients worldwide meet the strict standards set by pharma regulatory bodies. Through our integrated packaging and drug compatibility research platform, combined with the expertise of our toxicology team, we provide essential chemical characterization testing that enables stem cell media developers to meet regulatory expectations and achieve successful product registration.
Our facility in China is the only third-party lab in the country to have passed three consecutive US FDA on-site inspections, showcasing our strong track record in regulatory compliance. Our GMP-certified laboratory operates under international standards, including OECD, US FDA, NMPA, ICH, EMA and ISO.
With advanced capabilities and a deep commitment to quality, we continue to support the development of next-generation regenerative therapies, helping clients reduce R&D costs, accelerate timelines and bring innovative treatments to market faster.
For further information, please contact:
Colton Wong
VP Pharma APAC
t: +(86) 21 6064-5089
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
16th Floor, Block A, No.73 Fucheng Road, Century Yuhui Mansion,
Beijing, Haidian District, China