Ladies and gentlemen, distinguished guests, esteemed partners,
Thank you very much for attending our China Launch Event for the Pharmaceutical Mycoplasma Detection Culture Media, and for sharing your valuable time with us today.
The product we are unveiling today is not merely a culture medium. It is the culmination of our uncompromising pursuit of precision, reliability, and regulatory excellence — the embodiment of our company’s commitment to science-based quality and global compliance.
In recent years, mycoplasma contamination has come to be recognized as one of the most critical and insidious risks in the field of biopharmaceutical manufacturing, especially in the production of cell-based therapies, vaccines, and other sterile drug products. Regulatory authorities around the world have heightened their scrutiny, requiring increasingly sensitive and validated detection methods to safeguard product integrity.
Our new detection medium has been meticulously developed in full alignment with the standards of the Japanese Pharmacopoeia (JP), United States Pharmacopeia <USP 63>, and the ICH Q5D guideline. It offers dual compatibility with both liquid and solid-phase detection protocols, enabling high-sensitivity detection of organisms such as Mycoplasma orale and Mycoplasma hyorhinis across a wide range of sample types — including cell cultures, raw materials, and final products.
Manufactured entirely within our GMP-certified facility in Japan, this product complies with both ISO 9001:2015 and ISO 13485:2016, ensuring rigorous quality control from raw material intake to final batch release. Each lot undergoes comprehensive growth promotion testing, traceability documentation, and reproducibility verification to deliver batch-to-batch consistency, as well as full alignment with global regulatory expectations.
In introducing this product to China, we are not simply delivering a technical solution — we are providing an invisible shield for your GMP compliance, a trusted ally in your daily battle against contamination risk. We believe that quality is not a feature — it is a promise, and we are here to fulfill that promise with you.
Through today’s launch, we sincerely hope to build deeper partnerships with Chinese pharmaceutical manufacturers and QC professionals, contributing together to the advancement of safer, cleaner, and globally compliant drug manufacturing standards across Asia.
Because where others see risk, we offer certainty. Where others offer tools, we deliver trust.