The "Hidden Champions" Behind the Transformation of Biopharmaceutical Processes
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Traditional batch production is like baking cakes in batches, with each batch processed independently and interruptions and waiting periods between steps. This model is relatively simple for monoclonal antibody production. However, China's biopharmaceutical industry now stands at a critical crossroads—shifting from rapid, capital-driven expansion to a new phase defined by cost, efficiency, and global competition.
The industry's focus has moved from "Can we develop new drugs?" to "How can we manufacture new drugs efficiently, reliably, and competitively on the global stage?" Manufacturing processes, once behind-the-scenes, are now taking center stage strategically.
A recent process summit brought industry attention to this topic. Organized by Sartorius, a German life sciences company celebrating its thirtieth anniversary in China, this milestone marks a turning point in the industry cycle. Sartorius China General Manager Wang Xuyu noted that the company has witnessed China's biopharmaceutical boom. Today, the industry's core issues are "cost reduction and efficiency improvement" and "going global." Behind this is the ultimate demand for stable, efficient, and compliant production processes.
For Chinese pharmaceutical companies to go global, they must face the stringent standards for manufacturing processes set by international regulatory bodies such as the FDA and EMA. The quality of manufacturing processes has become a core strategic issue that determines a company's business success and international prospects.
The production model of biopharmaceuticals is undergoing a profound paradigm shift. The limitations of traditional batch production mode are becoming increasingly apparent in handling ever more complex biologic molecules. Continuous Manufacturing (CM), a global industrial trend, is becoming the key to breaking the mold.
The Global Wave of Continuous Manufacturing
Batch production is manageable for antibodies. But as biotechnology advances, drug molecules are becoming unprecedentedly diverse and complex. Wang Xuyu points out that today’s biologics have expanded from monoclonal antibodies to bispecific and multispecific antibodies, antibody-drug conjugates (ADC), and even gene therapy, cell therapy, and nucleic acid drugs.
These complex molecules are often extremely sensitive to production environments, and in the prolonged cycles of batch production, issues such as process instability and molecular degradation can easily arise, presenting great challenges to final product stability and consistency. Moreover, batch production requires enormous plant space and equipment investment, with scale-up dependent on larger reactors, making it inflexible and costly to operate.
Continuous manufacturing offers a brand-new solution. It links upstream and downstream production units into an uninterrupted, automated process flow, with materials continuously entering and products continuously produced, akin to a modern assembly line. This model brings significant advantages.
Global market data confirm the inevitability of this trend. According to Grand View Research, the global continuous bioprocessing market is expected to grow from USD 349.3 million in 2024 to USD 911.4 million in 2030, with a compound annual growth rate of 18.63%. The key driver is that continuous manufacturing can reduce production costs by 20–25% and shorten production cycles by 30–40%. More importantly, with real-time Process Analytical Technology (PAT) and automated controls, continuous manufacturing can ensure high product quality consistency, which is exactly what regulators value most.
Transforming a global technological concept into a solution tailored to local market needs tests a company’s strategic patience and execution skills. Sartorius’s path in promoting continuous manufacturing in China embodies its “customer-driven solutions” innovation philosophy.
The birth of Sartorius’s continuous flow process platform did not occur behind closed doors. At the communication meeting, Wang Xuyu shared that the original concept came from years of collaboration with French pharmaceutical giant Sanofi. At that time, Sanofi encountered challenges with traditional processes when developing a certain biologic molecule, which led to the idea of developing a continuous flow process. Based on trust in Sartorius’s upstream and downstream equipment and data integration capabilities, the two parties formed a joint project team to gradually turn the concept into reality.
The core logic of Sartorius’s innovation is clear: deeply engage with clients to understand and solve the toughest process challenges. This cooperative model ensures that the technology is closely aligned with real-world application scenarios from its inception.
When Sartorius shifted its vision for continuous manufacturing to China, it adopted the same careful, customer-centric approach. First was demand verification. By visiting over 40 Chinese clients, Sartorius confirmed the local companies’ urgent desire for more efficient and robust manufacturing processes.
Data show that while the penetration rate of upstream continuous processes such as N-1 perfusion in China is about 56%, achieving end-to-end full continuous processing faces its real bottleneck in downstream purification. The continuous transformation of downstream processes is challenged by automation equipment, process analytical technology, data integration, and regulatory requirements.
For any pharmaceutical company, adopting a disruptive new manufacturing platform entails significant risk, including high initial investment, complex process validation, and regulatory approval uncertainty. In China, this uncertainty is even greater. To lower the adoption threshold industry-wide, Sartorius partnered with the Shanghai Biopharmaceutical Industry Association, industry experts, and regulators to jointly initiate and publish the "White Paper on Continuous Flow Intensification Processes for Biopharmaceuticals," thus shifting from a mere equipment supplier to a co-builder of industry standards and a leader of technological pathways.
Growing Together with Clients: A Thirty-Year Partnership with Rongchang Bio
If driving industry standards showcases Sartorius’s breadth, then the nearly thirty-year deep partnership with Rongchang Bio vividly exemplifies its value as a “long-term partner.” This case translates all the abstract concepts of localization, partnership, and empowering innovation into tangible, concrete business practice.
This partnership began before Rongchang Bio shifted to biopharmaceuticals. Wang Xuyu recalls that when Rongchang first entered the biopharmaceutical field, "they didn’t even have a single tank,” and Sartorius provided demo equipment to help them start process development from scratch. This trust established in the client’s earliest days became the bedrock for long-term cooperation.
As Rongchang Bio progressed from preclinical stages to commercialization, Sartorius supported multiple innovative drugs’ manufacturing needs globally and domestically, always serving as a core partner for scale-up and capacity building. Information shows Sartorius helped Rongchang Bio establish dozens of production lines, provided advanced instruments such as cell culture reactors to boost manufacturing efficiency, aided large-scale production of innovative drugs like Taithaisip, and completed all facilities’ delivery in 2024.
Sartorius’s value extends far beyond equipment. When Rongchang Bio embarked on international expansion and sought business development (BD) overseas, Sartorius leveraged its global network to connect them with resources in the US and Europe, broadening international cooperation channels. This reflects Sartorius’s evolution from technical enabler to strategic partner.
“Drug development is a long-term commitment... Sartorius also has the patience and determination to grow together with clients,” Wang Xuyu added.
Conclusion
From making its first laboratory balance in Beijing to producing precision biomolecular interaction instruments in Shanghai; from delivering Rongchang Bio’s first reactor to helping Chinese pharmaceutical companies meet global regulatory challenges, Sartorius’s role now goes far beyond that of a supplier, providing critical tools, technologies, and methodologies to enable maturation of China’s biopharmaceutical industry.
As Wang Xuyu put it, Sartorius’s vision for the future is to continue empowering Chinese partners and together turn the ambition of “China’s new drugs” into the reality of “good drugs globally.” As technological needs and policy tailwinds converge, this thirty-year journey is now reaching its moment of value realization.
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