Bioprocess Insights: Zhou Weichang of WuXi Biologics on the Tipping Point of Explosive Growth in the Cell Culture Media Industry

Early this year, Dr. Zhou Weichang, Chief Technology Officer and Executive Vice President of WuXi Biologics, published an opinion piece in the professional journal GEN News, outlining future trends in bioprocessing technology development.

Zhou Weichang believes that the development of COVID-19 therapeutic drugs has achieved an unprecedented pace, which may herald the onset of a transformation in biopharmaceutical R&D. Accelerated development timelines have become one of the key features of future bioprocessing advancements. In addition to continuing to leverage innovative technologies to shorten R&D cycles, bioprocess development will further focus on reducing production costs.

Prior to joining WuXi Biologics in the winter of 2012, Zhou Weichang had worked in the U.S. biopharmaceutical industry for nearly two decades, including nearly nine years at Merck & Co., six years at PDL BioPharma, and five years at Genzyme. He is highly regarded in the industry for his globally leading achievements in protein expression and cell culture. His areas of expertise include the development and industrial-scale manufacturing of production processes for therapeutic proteins, monoclonal antibodies, and viral vaccines.

At WuXi Biologics, Zhou Weichang laid the foundation for establishing a biopharmaceutical process development platform, building a comprehensive technical team and CMC (Chemistry, Manufacturing, and Controls) platform from the ground up. Currently, the biopharmaceutical development team directly led by Zhou Weichang has grown to over 4,000 members, making it the largest team within WuXi Biologics and the largest of its kind internationally.

Drawing on extensive experience in process development and industrialization in both China and the United States, Zhou Weichang offers unique insights into the biopharmaceutical industry chain and emerging trends in biopharmaceutical manufacturing processes.

Cell culture media are among the most critical materials in the biopharmaceutical manufacturing process and represent an essential requirement for the industrialization of biomedicine. Recently,Artery New Medicine, in collaboration with Thermo Fisher Scientific, conducted an exclusive interview with Dr. Zhou Weichang.

Dr. Zhou Weichang recounted his connection to the cell culture media industry and the development trends of raw materials for media production, introduced WuXi Biologics’ latest process advancements, and shared cutting-edge insights into the industry—How Emerging Technology Innovations Are Shortening R&D Timelines, Reducing Costs, and Ushering in a New Era of Transformation in Biologics Development

Since its establishment in 2011, WuXi Biologics has achieved sustained rapid growth through its integrated CRDMO (Contract Research, Development and Manufacturing Organization) business model, which serves large enterprises while empowering small and medium-sized enterprises. In 2021, the company marked the inaugural year of its commercial manufacturing operations, with as many as nine commercial production projects.

WuXi Biologics’ performance has also risen year after year, with revenue climbing from RMB 330 million in 2014 to RMB 10.29 billion in 2021, and net profit surging from RMB 42 million to RMB 3.5 billion, representing a compound annual growth rate (CAGR) of 88.2%. Both in China and globally, WuXi Biologics ranks among the leaders in terms of growth rate and market share in the biologics research, development, and manufacturing services market.

Behind the rapid growth lies the tremendous opportunity brought by the booming global biopharmaceutical industry. Zhou Weichang remarked, “The development of China’s biopharmaceutical industry has played an indispensable role in this.”

VCBeat New Medicine:WuXi Biologics has experienced sustained high-speed growth in recent years; what do you think are the main reasons for this?

Dr. Zhou Weichang:First, WuXi Biologics is a technology platform-enabled company. In the past, companies involved in the field of biologics were typically “small but comprehensive” or “large and comprehensive,” integrating R&D, development, and manufacturing to build a full industry chain. However, nowadays, an increasing number of small and medium-sized enterprises are focusing on the R&D segment, and globally, there are far more companies specializing exclusively in biologics R&D than those operating across the entire industry chain.

Taking the United States as an example, there are only about 10 to 20 companies capable of becoming leaders across the entire industry chain. In contrast, there are thousands of companies engaged in biological drug research and development. This has formed a stable supply-and-demand relationship. While the core value of many biotech firms lies in identifying the most promising molecules and drugs, the subsequent steps—translating these best-in-class candidates from the laboratory to clinical trials and ultimately achieving commercial-scale manufacturing—are typically accomplished through CDMO (Contract Development and Manufacturing Organization) partners.

In the past, traditional CDMO companies in the industry primarily focused on manufacturing services. The emergence of WuXi Biologics as a technology-enabled platform has better met the R&D service needs of small and medium-sized enterprises centered on innovation, representing favorable timing. China’s increasing emphasis on the development of the pharmaceutical and healthcare industry, coupled with substantial investment support for the discovery, development, and production of biologics, constitutes favorable geographic and policy conditions.

Moreover, there is the advantage of human capital. In recent years, China has cultivated a large pool of top-tier talent, not only training many professionals in biopharmaceuticals at domestic universities but also attracting a significant number of overseas-educated returnees. Talent clusters have formed across all segments of the biopharmaceutical industry.

Amidst broader industry trends, WuXi Biologics has established end-to-end technical capabilities within the sector, enabling the rapid advancement of drug candidates from concept to clinical stages and supporting clients in bringing their products to market. Few companies worldwide possess such end-to-end capabilities; it is precisely this ability to meet customer demands that has driven WuXi Biologics’ sustained high-speed growth.

VCBeat New Medicine:WuXi Biologics has consistently emphasized placing product quality first. How, then, has it established a system that truly “puts quality first”?

Dr. Weichang Zhou:First,We have set the standards to be the highest in the world.The standards we have established and the quality system we have built comply with the requirements of global pharmaceutical regulatory agencies. Our mission is to empower any company to develop biologics for global use.

Achieving this is no easy feat. How did WuXi Biologics accomplish it? We have not only built robust technology platforms but also further established a comprehensive service chain for biologics, spanning from laboratory development to clinical and commercial manufacturing. Taking animal cell-expressed biologics as an example, WuXi Biologics possesses the capability to develop cell lines, along with expertise in cell culture, protein purification, physicochemical structural analysis, formulation, and large-scale production.

In addition to building capabilities,WuXi Biologics also places great emphasis on economies of scale.Globally, we have manufacturing facilities in different regions for our customers to choose from; products can be manufactured not only in China but also in the United States, Ireland, and Germany. Finally, we are building a highly professional and efficient technical team capable of problem-solving.

VBNewMed:How Does WuXi Biologics View Technological Innovation?

Dr. Weichang Zhou:Technological innovation is the foundation of WuXi Biologics and has always been given the highest priority.We have been continuously exploring how to leverage technological innovation to more effectively and swiftly overcome technical challenges, deliver solutions, and empower our clients.

I have worked in this industry for more than 30 years. In the early days of working with monoclonal antibodies, I found that even with the best culture media, cell expression levels were only 0.01 grams per liter. Producing antibodies at this expression level would cost approximately $10,000 or more per gram, making industrialization very difficult.

Through three decades of technological innovation and advancement, the overall standards of the industry have been significantly elevated. WuXi Biologics continuously explores and applies global innovative concepts and cutting-edge technologies, vigorously developing continuous flow manufacturing processes to achieve high yield, high quality, high flexibility, and low cost for biologics production. Currently, the production cost of monoclonal antibodies has been reduced to as low as $40 per gram. This exemplifies the appeal and value of technological innovation, which also serves as the foundation and guarantee for industrialization.

Zhou Weichang’s initial foray into the field of animal cell culture dates back to 1992, thirty years ago. At that time, Zhou was conducting scientific research at the University of Minnesota in the United States, where expensive cell culture media were essential for cell cultivation. Later, he joined Merck & Co. in the U.S., further advancing research on using animal cell culture techniques for viral vaccine production.

Every industry follows a certain development cycle. Over the past 30 years, Zhou Weichang has witnessed cell culture media evolve from a niche sector into the foundation of biopharmaceutical industrialization. “This has been a remarkable journey. For decades, Gibco has remained committed to scaling up the cell culture media business, reducing costs, improving efficiency, and ensuring a stable supply. Having done so for 60 years, it has supported the growth of the entire biologic drug industry—a truly formidable achievement.”

"China's biopharmaceutical industry needs enabling platform companies like WuXi Biologics, as well as supply chain players like Thermo Fisher Scientific. 'We are all part of an ecosystem, with each link interdependent; by optimizing every segment, we achieve greater speed and better outcomes—much like a marathon relay race, which is undoubtedly faster and yields superior results compared to an individual running a marathon.'"

VBHealthcare:What Does Cell Culture Media Mean to the Biopharmaceutical Industry in the Entire Biopharmaceutical Manufacturing Process?

Dr. Weichang Zhou:Many people would say that the production of most biologics begins with cell culture, a practice dictated by the nature of the industry. For the biopharmaceutical sector, failure to establish robust cell culture processes renders all other efforts futile; it leads to low cellular expression yields, thereby hindering the effective advancement of downstream steps such as purification, analysis, and formulation. Therefore,Cell culture and culture media are the cornerstones of this industry.

VCBeat New Medicine:What are the reasons behind WuXi Biologics’ decision to partner with Thermo Fisher Scientific’s Gibco for cell culture media selection?

Dr. Zhou Weichang:WuXi Biologics has always prioritized quality assurance and adhered to international standards. Therefore, whether for culture media, purification resins, or bioreactors, we select suppliers with the highest global quality credentials. As a leading global provider of cell culture media, Gibco has long supported cell culture applications across various fields, including vaccines, antibodies, recombinant proteins, and cell and gene therapies. Its products are suitable for diverse cell types and cell lines, such as mammalian, insect, yeast, and E. coli cells, and their quality has been thoroughly tested and validated over time. Now celebrating its 60th anniversary, Gibco has indeed reached a significant milestone.

VCBeat New Medicine:You have also had a 30-year relationship with Gibco. Have these three decades witnessed the development of both Gibco and the cell culture media industry?

Dr. Weichang Zhou:Yes, I first entered the field of animal cell culture in 1992, when I used many Gibco culture media. It has been 30 years now. Thirty years ago, animal cell culture was a very difficult task, with not only low cell concentrations but also low yields. However,Gibco’s culture media were a household name at the time, renowned not only for their superior stability but also for their ability to shorten cell doubling times, enhance the quality of cultured cells, and boost expression levels. As a result, Gibco’s cell culture media were widely regarded as a reliable choice.

Over the past 30 years, I have consistently focused on one critical issue: how culture media can prevent viral contamination of cells. The most crucial step in this process is the complete removal of all animal-derived components from the culture media. Initially, serum was eliminated and replaced with proteins. Subsequently, even animal-derived proteins were removed. More advanced approaches involve the use of chemically defined components. Early chemical formulations still contained animal-derived substances; for instance, certain amino acids were extracted from hair. These too are now being gradually phased out. To date, the optimal culture media, particularly for modern biopharmaceutical applications, are fully chemically defined and free of any animal-derived ingredients.

Over the past 30 years, cell culture media have evolved from serum-containing formulations to fully chemically defined ones, achieving a significant leap in quality that not only reduces contamination but also lowers costs.Media free of animal-derived proteins and serum will become a major direction for future industry development.

Furthermore, I was heavily involved in vaccine R&D early in my career. Currently, certain cell lines used for vaccine production still lack optimal culture media and remain dependent on low-concentration serum to support their growth. Therefore, animal-component-free culture media are poised to make significant advances in the vaccine field.

From my perspective, the adoption rate of continuous manufacturing processes in the industry will continue to rise. Since first introducing the concept of chemically defined (CD) media, Gibco culture media has continuously innovated and evolved. In the past two years, it has launched specialized media for continuous processing, enabling easier reconfiguration of production setups to meet flexible and dynamic demands. Consequently, the application of Gibco culture media in this process keeps pace with technological advancements, as it helps enhance yield and reduce costs.

VCBeat New Medicine:Apart from imported brands like Gibco, do you think the domestic cell culture media industry has developed rapidly in recent years? What are some of the major improvements?

Dr. Zhou Weichang:The domestic cell culture media industry has developed rapidly, driven by a deepening understanding of cell culture and a strong technical foundation for media development. Thirty years ago, cell culture was regarded as a “black box,” relying primarily on experience and empirical skills; requirements for culture media were only vaguely understood. Today, however, the composition of cell culture media is much better characterized.

Therefore, to some extent, developing culture media today is relatively less challenging than it was 30 years ago. However,Challenges remain. First, it is essential to fully characterize the components of the culture medium and ensure a stable supply chain for each component.A culture medium typically contains 70 to 80, or even 80 to 90, different components, each of which requires a robust supply chain—a highly challenging endeavor.Additionally, scaling up takes time.In addition to manufacturing culture media, companies must devote substantial time to demonstrating the stability of their supply chains, among other factors.

VCBeat New Medicine:At approximately what point in time did the domestic cell culture media industry experience explosive growth?

Dr. Zhou Weichang:I believe the time is now. In recent years, China’s biopharmaceutical industry has witnessed rapid development, with many people underestimating the pace of progress in Chinese biologics. Over the past decade, the growth rate of China’s biopharmaceutical sector has actually far exceeded my own expectations from back then.

Taking PD-(L)1 antibodies as an example, more than ten domestic companies have engaged in their research and development. Since the first product was launched in 2018, China has seen the emergence of over ten PD-(L)1 products within just four years—a number exceeding the total global count of PD-(L)1 therapies. Therefore, with the robust growth of biopharmaceuticals in both domestic and overseas markets, product demand will increase significantly, necessitating an expansion in cell culture scale, which in turn will drive up the demand for cell culture media.

Whether it is WuXi Biologics or any other company in the supply chain, they should all recognize that since China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017, the gap between China’s standards for biologic drug development and global standards has been narrowing.

Zhou Weichang believes that, in this broader context, a favorable factor is that over the past few years, industry players have been focused on building platforms, and certain domestic infrastructure has already been established. Whether it is the development of supply chains or the emergence of platform-type enterprises such as WuXi Biologics, these advancements are empowering the development and manufacturing of biologics. “Once the platforms are in place, further optimization and innovation will drive faster and better growth in the future.”

Therefore, China’s biopharmaceutical industry will also enter a new phase, characterized by “greater innovation, more originative breakthroughs, and an increasing number of first-in-class novel drugs.”

VBNewPharma:What do you think are the future development trends in biopharmaceutical manufacturing processes?

Dr. Weichang Zhou:First, ensure product quality., this is a cliché. No matter how fast or well you do it, quality must be ensured.

Under these circumstances, speed is of paramount importance. It has long been said that developing a biologic drug typically takes 10 years and requires an investment of $1 billion; however, many patients cannot afford to wait for such a lengthy period. Therefore, we must consider how to accelerate the process from concept to clinical development and ultimately to commercialization. WuXi Biologics has empowered multiple partners in the development and manufacturing of neutralizing antibodies against COVID-19, enabling many companies to progress from DNA to Investigational New Drug (IND) application within just 3 to 6 months, and to achieve market launch from DNA in less than a year and a half.

Second, reduce production costs.As the number of biopharmaceutical products targeting the same indication continues to grow, competition is becoming increasingly fierce, making cost reduction particularly critical.

Furthermore, technological advancements across the entire biopharmaceutical manufacturing value chain, such as continuous flow processing, can significantly reduce purification costs. Modern analytical techniques, mass spectrometry, and bioactivity assays—key product quality control technologies—will simultaneously drive cost reduction and quality improvement. In the future, high-concentration formulations and pre-filled syringe technologies will also present substantial opportunities for development.

VCBeat Pharma:As the biopharmaceutical industry upgrades, what upgrading requirements do you anticipate for the entire supply chain?

Dr. Weichang Zhou:I believe it is the scalability and stability of the supply chain.

Disruptions in the upstream supply chain can halt downstream production, making it essential to ensure supply chain stability. At the onset of the COVID-19 pandemic, a surge in global demand for finished pharmaceutical products led to a shortage of glass vials for filling. Consequently, even if bulk drug substance could be produced, filling operations could not proceed, which emerged as the most critical issue.

Process stability is also critically important. Given that the supply chain encompasses various aspects, WuXi Biologics places significant emphasis on the stability of cell culture media, single-use bioreactors, purification processes, and formulation processes, as these are fundamental to scalable manufacturing.

In the early stages of biologic drug development, production costs were often not the primary concern; rather, the focus was on ensuring the reliability and high quality of the pharmaceutical products. Currently, as demand for biologics continues to grow, the cost of manufacturing has become increasingly significant. Therefore, reducing costs through economies of scale in raw materials and supply chain management will be a key direction moving forward.

Stability and scalability require time to refine. Taking cell culture media as an example, developing a high-quality formulation can be achieved quickly, but demonstrating its stability requires many years of data, which can only be proven over time. The same applies to the development of biopharmaceuticals; for instance, the most challenging and least acceleratable aspect is drug stability testing.

VB New Medicine:Do you believe that China’s biopharmaceutical industry has already established a comprehensive supply chain system?

Dr. Weichang Zhou:Currently, I believe the supply chain across the entire industry remains highly robust. However, due to the outbreak of the COVID-19 pandemic, both the industrial and supply chains have been impacted to varying degrees over the past two years. Nevertheless, this has also created new opportunities, enabling domestic enterprises to intensify their research and development as well as production of culture media, bioreactors, and other related products, thereby supporting the development and manufacturing of biopharmaceuticals.

Undoubtedly, as the scale of China’s biopharmaceutical industry expands, demand for upstream life science tools will grow. In the future, we will rely not only on imported raw materials and culture media but also on domestically produced brands.Whether biopharmaceutical companies or supply chain enterprises, they must be deeply rooted in the local market to better serve domestic businesses.

Additionally,The domestic biopharmaceutical industry also faces a significant challenge: how to balance production capacity and demand.

From my perspective, companies in China’s domestic industry are currently constructing manufacturing facilities too early and on an overly large scale, with a tendency to overestimate production capacity. This trend is gradually becoming apparent, and many biopharmaceutical enterprises will face the challenge of overcapacity. Low facility utilization rates hinder the reduction of production costs.

VCBeat New Medicine:What factors do you believe will be the key drivers of industry transformation?

Dr. Weichang Zhou:Similar to past industrial transformations, there are many common driving factors, namely how to accelerate product development and enhance cost-effectiveness. This includes technological innovations; for example, cell culture media have undergone multiple iterations over the past years, and further innovations are expected in analytical methods, purification, and formulation in the coming years.

If gene therapy and cell therapy are to be pursued, greater technological innovation is required.Over the past five years, the industrialization challenges encountered by cell therapy and gene therapy have not differed significantly from those faced by antibody therapies 25 to 30 years ago. However, once these technologies become platform-based, production costs will be substantially reduced.

The scale-up of gene therapy is very similar to that of antibody production. In the field of gene therapy, which includes technologies such as mRNA, robust process amplification can be achieved once an effective delivery system is identified. However, there are significant differences between the scale-up of cell therapy and that of antibodies. I am considering whether early vaccine manufacturing technologies could be applied to the field of cell therapy. The production costs in cell therapy will undoubtedly decrease; while I cannot predict how long this process will take, we hope to accelerate its progress.

In summary, China’s biopharmaceutical industry continues to maintain rapid growth, necessitating closer collaboration across the upstream and downstream segments of the supply chain. Whether it is contract development and manufacturing organizations (CDMOs) or cell culture media, which plays a critical role in the upstream supply chain, both are indispensable components of this industrial ecosystem. The research and development of biologics has ushered in an era of transformation, with promising innovations in bioprocessing technologies on the horizon. These advancements will facilitate the faster, better, and more efficient development and production of biologic drugs that benefit humanity.