The "Invisible Champions" Behind the Transformation of Biopharmaceutical Processes

Traditional batch production is like baking cakes in batches, where each batch is conducted independently, leading to interruptions and waiting times between processes. This model is at a critical crossroads in the relatively simple monoclonal antibody sector of China's biopharmaceutical industry. It is shifting from capital-driven rapid expansion to a new phase defined by cost, efficiency, and global competition.

The industry's focus has shifted from "Can new drugs be developed?" to "How to manufacture new drugs efficiently, stably, and with global competitiveness?" The production process, once a behind-the-scenes aspect, is being pushed to the strategic forefront.

A recent process summit has drawn the industry's attention to this issue. The organizer, Sartorius, a German life sciences company, coincidentally marks its 30th anniversary in China. This milestone signifies a turning point in the industry cycle. Wang Xuyu, General Manager of Sartorius China, stated that the company has witnessed the rapid growth of China's biopharmaceutical sector. Today, the core proposition of the industry is "cost reduction and efficiency improvement" and "going global." Behind this is an extreme demand for stable, efficient, and compliant production processes.

Chinese pharmaceutical companies must face the stringent standards of international regulatory bodies such as the FDA and EMA regarding production processes. The quality of manufacturing processes has become a core strategic issue determining the commercial success and international prospects of enterprises.

The production model of biopharmaceuticals is undergoing a profound paradigm shift. The limitations of traditional batch production are becoming increasingly apparent when dealing with the increasingly complex biopharmaceuticals. Continuous Manufacturing (CM), as a global industrial trend, is becoming the key to breaking through these limitations.

The Global Wave of Continuous Manufacturing

Antibodies can still cope. However, with the development of biotechnology, drug molecules have become unprecedentedly diverse and complex. Wang Xuyu pointed out that today's biopharmaceuticals have expanded from monoclonal antibodies to bispecific antibodies, multi-specific antibodies, antibody-drug conjugates (ADCs), as well as gene therapy, cell therapy, and nucleic acid drugs.

These complex molecules are often extremely sensitive to production environments, and the lengthy cycles of batch production can lead to process instability and molecular degradation, posing significant challenges to the stability and consistency of the final product. Additionally, batch production requires large factory spaces and equipment investments, with scaling up relying on larger reaction tanks, resulting in poor flexibility and high operational costs.

Continuous manufacturing offers a new solution. It connects upstream and downstream production units into a continuous, automated overall process, with materials continuously entering and products continuously being produced, akin to a modern assembly line. This model brings significant advantages.

Global market data confirms the inevitability of this trend. According to Grand View Research, the global continuous bioprocess market size is expected to grow from USD 349.3 million in 2024 to USD 911.4 million by 2030, with a compound annual growth rate of 18.63%. The core driving force behind this is that continuous manufacturing can 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 a high degree of consistency in product quality, which is highly valued by regulatory agencies Transforming a global technological concept into a solution that meets local market demands tests a company's strategic patience and execution capabilities. Sartorius's promotion of continuous manufacturing in China reflects its innovative philosophy of "solutions originate from customers."

The birth of Sartorius's continuous flow process platform is not a product of closed-door development. Wang Xuyu shared at a communication meeting that the initial concept of this technology originated from years of collaboration with the French pharmaceutical giant Sanofi. At that time, Sanofi faced challenges in developing a certain biopharmaceutical that traditional processes could not solve, which led to the idea of developing a continuous flow process. Based on trust in Sartorius's capabilities in upstream and downstream equipment and data integration, both parties formed a joint project team to gradually turn the concept into reality.

It is not difficult to see the core logic of Sartorius's innovation: deeply engaging with clients to understand and solve the most challenging process problems. This collaborative model ensures that technology is closely aligned with practical application scenarios from the very beginning.

When Sartorius turned its vision of continuous manufacturing towards China, it adopted the same cautious and customer-centric approach. The first step was to validate demand. By visiting over 40 Chinese clients, they confirmed the urgent desire of local companies for more efficient and robust production processes.

Data shows that while the adoption rate of upstream continuous processes like N-1 perfusion has reached about 56% in China, the real bottleneck in achieving end-to-end continuous processes lies in the downstream purification stage. The continuous nature of downstream processes faces multiple constraints, including automation equipment, process analytical technology, data integration, and regulatory compliance.

For any pharmaceutical company, adopting a disruptive new manufacturing platform entails significant risks, including high initial investments, complex process validation, and uncertainties in regulatory approval. In China, this uncertainty is particularly pronounced. To lower the adoption threshold for the entire industry, Sartorius chose to collaborate with the Shanghai Biopharmaceutical Industry Association, industry experts, and regulatory authorities to jointly lead the formulation and publication of the "White Paper on Continuous Flow Enhanced Processes in Biopharmaceuticals." This transformed its role from a mere equipment supplier to a co-builder of industry standards and a leader in technological pathways.

Growing Together with Customers: A Thirty-Year Commitment with RemeGen

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

This partnership began before RemeGen transitioned to biopharmaceuticals. Wang Xuyu recalls that when RemeGen first ventured into the biopharmaceutical field with "not a single tank," Sartorius provided its demonstration equipment to help them start process development from scratch. This trust, intervening at the very beginning of the client's journey, laid the foundation for long-term cooperation.

As RemeGen gradually moved from preclinical to commercialization, Sartorius supported its production needs for multiple innovative drugs globally and in China, always being its core partner in process scaling and capacity building. Information indicates that Sartorius has supported RemeGen in establishing dozens of production lines, providing advanced instruments and equipment, including cell culture reactors that enhance production efficiency, to assist in the scaled production of innovative drugs like Taitasib, with all facilities scheduled for delivery by 2024 Sartorius provides value that goes far beyond equipment. When RemeGen embarked on its globalization journey and sought overseas business development (BD), Sartorius leveraged its global network to connect it with resources in the United States and Europe, broadening its overseas cooperation channels. This reflects its role extending from a technology enabler to a strategic partner.

"Making drugs is a very long-term mission... Sartorius also has the patience and determination to accompany such clients in their growth," Wang Xuyu added.

Conclusion

From initially producing the first laboratory balance in Beijing to now manufacturing precision biomolecular interaction devices in Shanghai; from providing RemeGen with its first reactor to assisting Chinese pharmaceutical companies in tackling global regulatory challenges, Sartorius's role has transcended that of a mere supplier, providing key tools, technologies, and methodologies for the maturation of China's biopharmaceutical industry.

As Wang Xuyu stated, the future Sartorius envisions is to continue empowering Chinese partners to collectively transform the ambition of "China's new drugs" into the reality of "global good drugs." With the convergence of technological demands and favorable policies, this thirty-year layout is now ushering in its moment of value realization