Yuanda Pharmaceuticals Chooses Wiskind to Ensure a Full-Industry-Chain Production Environment for High-End Radiopharmaceutical Mass Production

Recently, the Chinese pharmaceutical industry received exciting news: Yuanda Pharmaceutical Group’s core product, Yttrium-90 ([⁹⁰Y]) microsphere injection, has been granted FDA approval in the United States for an additional indication. This makes it the first and only selective internal radiation therapy drug worldwide to simultaneously target both unresectable hepatocellular carcinoma and colorectal cancer liver metastases.

This milestone breakthrough not only marks China’s nuclear medicine moving from a follower to a global leader but also showcases the exceptional strength of Chinese innovative drugs to the world. Behind this achievement, in addition to Yuanda Pharmaceutical’s dedication and R&D capabilities, its Chengdu production base has served as a “super engine” for the industrialization of radiopharmaceuticals. Wiskind’s tailor-made professional cleanroom solutions have been a key factor in ensuring this engine operates efficiently.

Chengdu Base: Building a Globally Leading Full-Industry-Chain Platform for Radiopharmaceuticals

To promote high-quality development in the radiopharmaceutical industry, Yuanda Pharmaceutical invested over 3 billion RMB to establish a full-industry-chain, closed-loop radiopharmaceutical platform in Wenjiang District, Chengdu, integrating both R&D and production. The base officially commenced operations in June 2025, featuring 14 internationally certified GMP production lines, a full-chain AI operation system, and intelligent manufacturing systems, achieving comprehensive digitalization and automation of the production process.

Leveraging this base, high-end radiopharmaceuticals—including Yttrium-90 ([⁹⁰Y]) microsphere injections—have achieved localized mass production. Localization not only enhances the stability and responsiveness of drug supply but also effectively reduces treatment costs for patients, making this innovative therapy more accessible and affordable to those who need it.

Ultimate Cleanliness: The “Invisible Guardian” of Radiopharmaceutical Production

Radiopharmaceuticals are drugs that contain radioactive isotopes and are used for diagnosing or treating diseases. Yttrium-90 ([⁹⁰Y]) microsphere injection is a therapeutic radiopharmaceutical that precisely destroys tumor cells by emitting high-energy β-rays, playing a crucial role in cancer treatment.

Due to their unique nature, the production of radiopharmaceuticals requires extremely strict environmental conditions. According to China’s Good Manufacturing Practice for Radiopharmaceuticals, all related operations must be conducted within a cleanroom. In addition, the production environment must meet multiple stringent standards, including high cleanliness, precise temperature and humidity control, excellent sealing, corrosion resistance, and fire safety.

Wiskind: Empowering Safe Radiopharmaceutical Production with Innovative Solutions

Facing the stringent requirements of radiopharmaceutical production, Wiskind leveraged its extensive expertise in pharmaceutical cleanrooms to provide a tailor-made cleanroom enclosure system for Yuanda Pharmaceutical’s Chengdu base. The system uses glass–magnesium rock wool hand-assembled clean panels, composed of glass magnesium and high-quality water-repellent rock wool, forming a seamless structure with a highly flat surface. These panels offer excellent fire resistance, thermal insulation, corrosion resistance, and anti-contamination performance, creating a stable, clean, and safe production environment for radiopharmaceutical manufacturing, effectively ensuring product quality and operational safety.

A clean environment for radiopharmaceuticals must not only meet the basic GMP requirements but also achieve higher standards for dust control, cross-contamination prevention, and long-term stability. Wiskind builds on advanced technology and a commitment to quality, continuously safeguarding the production of radiopharmaceuticals.

Focusing on Pharmaceuticals: Partnering with Leading Companies to Advance Along the High-End Value Chain

As a key area of precision medicine, nuclear pharmaceuticals have experienced explosive growth in recent years, with a continuous emergence of domestic innovations and an increasingly complete industrial chain. 

Wiskind firmly believes in the vast potential of radiopharmaceuticals in tumor diagnosis and treatment and will continue to strengthen technological R&D and service upgrades. The company aims to provide the industry with high-standard, highly reliable cleanroom solutions, supporting the internationalization and high-quality development of China’s radiopharmaceutical industry.

Looking ahead, Wiskind will remain focused on the pharmaceutical cleanroom sector, partnering with more leading companies to jointly advance the pharmaceutical industry toward the high end of the global value chain.