Nanomicro Technology: Competing on the Frontline of Innovation to Empower Downstream Biopharmaceutical Purification

From a macroscopic perspective, the products manufactured by NanoMicro Technology for biopharmaceutical separation and purification resemble flour; however, their true structure is only visible under an electron microscope.

“Flour” is actually composed of highly uniform microspheres, each featuring countless interconnected nanopores. This structure results in an exceptionally large specific surface area, reaching the size of a standard football field per gram. It is precisely this high surface area that confers strong adsorption capacity. Therefore, through surface modification to impart specific adsorption properties for certain substances, these microspheres can isolate target bioactive drugs from complex systems.

Microsphere materials for biopharmaceuticals appear ordinary, resembling flour, yet their manufacturing technology is extremely challenging. For a long time, China has relied heavily on imports for chromatographic media microspheres used in the separation and purification of biopharmaceuticals, resulting in high costs and long lead times.

To achieve domestic self-sufficiency in key microspherical separation media for downstream biopharmaceutical processing, NanoMicro Technology has adhered to the philosophy of “winning respect through innovation” since its inception. By persistently committing to R&D and overcoming the technical challenges associated with the precise fabrication of microspheres, the company has achieved multiple world-first breakthroughs and successfully launched high-performance microsphere products for biopharmaceutical separation and purification, thereby breaking the import monopoly on microsphere materials in China.

Over the past decade-plus of R&D and innovation, NanoMicro Technology has chosen the most challenging path: disruptive or foundational innovation. Although this journey is long and arduous, it positions NanoMicro Technology for greater long-term success.

Now, NanoMicro Technology has become the only company in the world capable of large-scale production of monodisperse porous silica chromatography packing microspheres. Leveraging its world-leading nano- and microsphere preparation technology, the company has gained recognition from over a hundred pharmaceutical enterprises in China and has exported more than 10,000 liters of high-performance packing materials to major pharmaceutical companies in Europe, the United States, and South Korea, thereby reversing China’s previous reliance on one-way imports of chromatography packing materials.

In 2004, Dr. Jiang Biwang, the founder of NanoMicro Technology, returned to China after working in the United States for ten years. By chance, he learned that a relative from his rural hometown required long-term insulin injections for diabetes. At that time, insulin was largely dependent on imports and was prohibitively expensive, imposing a significant financial burden on his already modest family. Dr. Jiang earned his bachelor’s degree in Chemistry from Peking University and later obtained his Ph.D. in the United States, where he engaged in long-term research on polymer materials.

Dr. Jiang Biwang stated, “Although we cannot produce biologics themselves, downstream separation and purification account for approximately 50%–70% of the total production costs in the biopharmaceutical industry. At that time, China lacked domestically produced purification media, relying entirely on expensive imports. Developing high-performance chromatography materials would reduce the overall cost of biopharmaceutical manufacturing, thereby naturally lowering medication costs for the general public.”

From the perspective of industrial value, bio-The production of biopharmaceuticals is generally divided into upstream fermentation processes and downstream separation and purification processes.Over the past decade, upstream fermentation technology has advanced rapidly, with titers increasing from an initial 0.5 g/L to 5 g/L, and now reaching over ten grams per liter. This represents a more than tenfold increase in upstream production efficiency.

However, downstream separation and purification technologies have become disconnected from the development of upstream fermentation."Therefore, how to economically and efficiently concentrate, separate, and purify target biomolecules from complex mixtures has become a major technical bottleneck in global biopharmaceutical production, while also impacting drug quality and cost. A breakthrough in this field would hold significant implications for the global biopharmaceutical industry."

With the rapid development of biopharmaceuticals, their varieties are becoming increasingly diverse and their structures more complex. Meanwhile, regulatory authorities are imposing stricter purity requirements on biopharmaceuticals, making the separation and purification of these drugs increasingly challenging. Due to the complex structures, poor stability, and low concentrations characteristic of biological macromolecules, traditional purification methods for small-molecule drugs—such as recrystallization and fractional distillation—fail to meet the separation and purification requirements for biological macromolecules. Liquid chromatography, or chromatographic technology, offers exceptionally high separation and purification efficiency under mild conditions, thereby facilitating the preservation of the biological activity of target molecules during the process. Consequently, chromatography has become the most critical purification tool in biopharmaceutical manufacturing.

Chromatography media are the heart of biopharmaceutical separation and purification systems, with separation efficacy largely dependent on the chromatographic microspheres. Chromatography media used for biopharmaceutical separation and purification are subject to stringent requirements regarding material composition, particle size, morphology, uniformity, pore structure, surface functional groups, and mechanical strength.Due to the high technical complexity and significant entry barriers, China’s chromatography media industry is largely monopolized by a few foreign companies, with the Chinese market having long relied on imports for high-performance chromatography media.

When determining the strategic direction, Dr. Jiang Biwang faced two paths: one was a follow-the-leader strategy—imitating existing products for rapid industrialization; the other was pursuing complete independent innovation to develop disruptive products.

Dr. Jiang, an entrepreneur with a technical background, possesses the intellectual pride characteristic of scholars. He is more inclined to compete on the global stage of innovation, pursuing true breakthroughs rather than settling for what is merely deemed innovative within China.

He stated, “Chinese people are often accused worldwide of merely imitating and plagiarizing, lacking the capacity for genuine innovation. I am determined to prove that Chinese people also possess true high-end innovative capabilities. Therefore, only by creating disruptive products unavailable anywhere else in the world can we earn genuine respect and recognition.”

However, innovation is easier said than done. Taking monodisperse silica chromatography media as an example, NanoMicro Technology spent a full decade to industrialize this disruptive technology. It became the first company in the world capable of mass-producing silica chromatography media with precise particle sizes and high uniformity, thereby significantly enhancing its separation performance.

Choosing the path less traveled is destined to be fraught with thorns. NanoMicro Technology needs to overcome numerous challenges in industrialization.

A major challenge is the lack of a complete industrial chain, a dilemma frequently encountered by domestic innovators. In the United States, entrepreneurs can focus on their own technologies and products, as it is relatively easy to find matching products in the upstream and downstream supply chains. However, more than a decade ago, China’s related industries were still underdeveloped, which posed significant difficulties for the industrialization of NanoMicro Technology. As a result, NanoMicro had to address not only its own key technological issues but also problems related to upstream materials and equipment.

After a decade of dedicated effort, NanoMicro Technology has grown from its humble beginnings in a rented space of just over 100 square meters to operating two independent production bases spanning more than 30,000 square meters. Yet what Dr. Jiang Biwang takes greatest pride in is having demonstrated the independent innovation capability of Chinese people. As one of the pioneers in China’s drive for indigenous innovation, NanoMicro Technology’s success has proven that the path toward high-end independent innovation is viable.

As a "newcomer" to the nano-microsphere industry, NanoMicro Technology has won the recognition of over one hundred domestic pharmaceutical companies with its world-leading preparation technology for nano- and microspheres. Meanwhile, it has exported tens of thousands of liters of high-performance chromatography media to large pharmaceutical enterprises in Europe, the United States, South Korea, and other regions, reversing China's passive situation of relying solely on imports for chromatography media.

“In fact, what China lacks is not talent for technological innovation, but the patience and determination required to translate innovative technologies into products. I hope that more Chinese entrepreneurs and innovators will be willing to devote themselves to developing original technologies and, with patience and determination, achieve their industrialization. By creating world-class technologies and products in every niche sector, China can earn global respect and truly transform its industries from large to strong.”