Traditional batch production operates like baking cakes in separate batches, with each batch proceeding independently and interruptions and waiting periods between processes. This model can handle the production of relatively simple monoclonal antibody manufacturing, but China's biopharmaceutical industry now stands at a critical crossroads, transitioning from capital-driven rapid expansion to a new phase defined by cost control, efficiency, and global competition.

The industry focus has shifted from "whether we can develop new drugs" to "how to manufacture new drugs efficiently, stably, and with global competitiveness." Manufacturing processes, once a behind-the-scenes operation, are now being pushed to the strategic forefront.

A recent process summit brought industry attention to this transformation. The organizer, Sartorius, a German life sciences company, marked its 30th anniversary in China. This milestone represents a turning point in the industry cycle. Wang Xuyu, General Manager of Sartorius China, stated that the company has witnessed the rapid development of China's biopharmaceutical industry. Today, the industry's core themes are "cost reduction and efficiency improvement" and "going global," which demand the highest standards of production process stability, efficiency, and compliance.

As Chinese pharmaceutical companies venture into global markets, they must face stringent production process standards from international regulatory agencies such as the FDA and EMA. The quality of manufacturing processes has become a core strategic issue determining companies' commercial success and internationalization prospects.

Biopharmaceutical production models are undergoing a profound paradigm shift. The limitations of traditional batch production modes become increasingly apparent when dealing with increasingly complex biomacromolecule drugs. Continuous Manufacturing (CM), as a global industry trend, is becoming the key to breaking through these limitations.

**The Global Wave of Continuous Manufacturing**

Traditional batch production was sufficient for antibodies but inadequate for today's diverse and complex drug molecules. Wang Xuyu pointed out that today's biological drugs have expanded from monoclonal antibodies to bispecific antibodies, 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. During the lengthy cycles of batch production, issues such as process instability and molecular degradation can easily occur, posing enormous challenges to the final product's stability and consistency. Additionally, batch production requires massive factory space and equipment investment, with scale-up dependent on larger reaction vessels, resulting in poor flexibility and high operational costs.

Continuous manufacturing offers an entirely new approach. It connects upstream and downstream production units into an uninterrupted, automated integrated process, with materials continuously entering and products continuously emerging, like a modern assembly line. This model brings significant advantages.

Global market data confirms the inevitability of this trend. According to Grand View Research forecasts, the global continuous bioprocess market size is expected to grow from $349.3 million in 2024 to $911.4 million in 2030, with a compound annual growth rate of 18.63%. The core driving force lies in continuous manufacturing's ability to reduce production costs by 20-25% and shorten production cycles by 30-40%. More importantly, through real-time Process Analytical Technology (PAT) and automated control, continuous manufacturing can ensure high product quality consistency, which regulatory agencies value highly.

Transforming a global technological concept into solutions adapted to local market needs tests a company's strategic patience and execution capabilities. Sartorius's approach to promoting continuous manufacturing in China reflects its innovation philosophy of "solutions originating from customers."

The birth of Sartorius's continuous flow process platform was not the result of closed-door development. Wang Xuyu shared during a communication meeting that the initial concept of this technology originated from years of collaboration with French pharmaceutical giant Sanofi. When Sanofi encountered challenges in developing a certain biomolecule that traditional processes couldn't solve, they conceived the idea of developing continuous flow processes. Based on trust in Sartorius's capabilities in upstream and downstream equipment and data integration, both parties formed a joint project team, gradually transforming the concept into reality.

This reveals Sartorius's core innovation logic: deeply engaging with customers to understand and solve the most challenging process problems. This collaboration model ensures that technology is closely aligned with practical application scenarios from its inception.

When Sartorius turned its continuous manufacturing vision to China, they adopted the same cautious and customer-centric approach. First was demand validation. By visiting over 40 Chinese customers, they confirmed local enterprises' urgent desire for more efficient and robust production processes.

Data shows that while upstream continuous processes such as N-1 perfusion have achieved approximately 56% adoption in China, the real bottleneck for achieving end-to-end fully continuous processes lies in downstream purification. Downstream process continuity faces multiple constraints including automation equipment, process analytical technology, data integration, and regulatory frameworks.

For any pharmaceutical company, adopting a disruptive new manufacturing platform means enormous risks, including high initial investments, complex process validation, and regulatory approval uncertainties. In China, this uncertainty is particularly prominent. To lower the adoption threshold for the entire industry, Sartorius chose to collaborate with the Shanghai Biopharmaceutical Industry Association, industry experts, and regulatory departments to jointly lead the development and publication of the "Biopharmaceutical Continuous Flow Enhanced Process White Paper," transforming its role from an equipment supplier to a co-builder of industry standards and a leader in technical pathways.

**Growing Together with Customers: A Thirty-Year Partnership with REMEGEN**

If promoting industry standard development reflects Sartorius's breadth, then the nearly thirty-year deep cooperation with REMEGEN vividly illustrates its value as a "long-term partner." This case transforms all abstract concepts about localization, partnerships, and innovation enablement into tangible business practices.

This collaborative relationship began before REMEGEN's transformation into a biopharmaceutical company. Wang Xuyu recalled that when REMEGEN initially entered the biologics field "without a single tank," Sartorius provided its demonstration equipment to help them start process development from scratch. This trust, established during the customer's earliest stages, laid the foundation for long-term cooperation.

As REMEGEN progressed step by step from preclinical to commercialization, Sartorius supported its multiple innovative drugs' production needs globally and in China, consistently serving as its core partner for process scale-up and capacity building. Information shows that Sartorius supported REMEGEN in establishing dozens of production lines, providing advanced instruments and equipment including cell culture reactors that improve production efficiency, facilitating large-scale production of telitacicept and other innovative drugs, with all facilities delivered in 2024.

Sartorius's value extends far beyond equipment. When REMEGEN embarked on its globalization journey, seeking overseas business development (BD), Sartorius leveraged its global network to help connect with resources in the United States and Europe, expanding overseas collaboration channels. This reflects its role extension from technical enabler to strategic companion.

"Drug development is a very long-term mission... Sartorius also has such patience and determination, willing to accompany such customers in their growth," Wang Xuyu added.

**Conclusion**

From initially producing the first laboratory balance in Beijing to now manufacturing precision biomolecular interaction equipment in Shanghai; from providing the first reactor to REMEGEN to helping Chinese pharmaceutical companies address global regulatory challenges, Sartorius's role has transcended that of a simple supplier, providing crucial tools, technologies, and methodologies for the industrial maturation of China's biopharmaceutical sector.

As Wang Xuyu stated, Sartorius envisions a future of continuing to empower Chinese partners, jointly transforming the ambition of "Chinese new drugs" into the reality of "globally excellent drugs." With the convergence of technological demands and policy tailwinds, this thirty-year strategic positioning is approaching its moment of value realization.