Driving Biopharma Commercial Success through Redefined CRDMO Partnerships

The contract research, development and manufacturing industry has advanced rapidly in recent years. There has been particular growth in biopharma capabilities, as an increasing number of drug developers have partnered and collaborated with CDMO companies able to provide flexible solutions to deliver novel, increasingly complex modalities, quickly and reliably. As well as investing in state-of-the-art biologics facilities, the development of specialized proprietary platforms can enhance quality and delivery, as demonstrated by WuXi Biologic’s recent next-generation platform WuXiHigh™2.0 for high-concentration biologics, its high-efficiency continuous perfusion manufacturing technology platform WuXiUP™ and its ultra-intensified fed-batch platform WuXiUI™. Most recently, in September 2025, WuXi Biologics launched WuXia^TM TrueSite, a targeted integration cell line platform to accelerate biologics development with high titer and superior stability.

In light of these recent developments, and in recognition of the fact that more and more companies are turning to outsourcing partners to meet their biologics research, development and manufacturing needs, we spoke to Dr. Chris Chen, CEO of WuXi Biologics, to ask how the top-tier CRDMO is helping biopharma companies stay ahead of rapid developments in the sector, and how they ensure that quality, reliability and speed of delivery are provided consistently across all WuXi Biologics sites worldwide.

Q: What are the main manufacturing pain points in today’s biopharma industry, and how is WuXi Biologics positioned to address and adapt to these challenges?

Chris: A key pain point lies in the misalignment between large-scale capacity on one side and the growing demand for flexible volume capabilities on the other. Fluctuating demand is now the norm, and a higher proportion of products are only needed in relatively small volumes. However, for larger CMOs, integrating small-batch production into their large-scale commercial lines is a struggle. For small and medium-sized biotech firms, this challenge is not just a logistical hurdle but a make-or-break factor for their product’s market entry and viability.

Additionally, the average titer of commercial biologics grew from 0.2g/L in the 1990s to 3.5g/L in 2023. Over 12% of commercial biologics’ titer is now above 6g/L, and our newly launched CHO cell line platform WuXia^™ TrueSite has achieved an average mAb titer of more than 8g/L. A 2000L bioreactor can now meet the demand of over 50% of marketed biologics. This is why we see biopharmaceutical companies transitioning from large-volume, single-product plants to small-volume, multi-product facilities. All this means that flexibility has become critical to handle products of diverse scales, from small batches for niche therapeutics to larger volumes for larger treatment groups.

We believe that these developments align with the advantages of single-use bioreactors (SUBs), which can be efficiently and quickly deployed to meet a range of required production volumes. This makes SUBs cost and resource efficient, while offering flexible and responsive manufacturing. Added to the fact that a scale-out strategy (e.g., using several smaller individual SUBs simultaneously to produce higher volumes) can achieve industrial-scale results at laboratory scale methodology, production can be significantly accelerated, as we can circumvent the challenges of process scale-up. The integration of our proprietary process development platforms (e.g., WuXiUI™, WuXiUP™) can bring even further productivity of 5-7X with reduced costs.

This is why we believe that, compared with large-scale stainless bioreactors, smaller SUBs are leading the future of biomanufacturing. It also explains why WuXi Biologics has built its manufacturing edge around Single-Use Technologies (SUT), a core pillar of our 500,000L+ global bulk capacity plan. Unlike stainless-steel systems that take years to build and require lengthy cleaning and maintenance, our SUT-based reactors cut setup and turnaround times by over 40%.

Our transition to SUT addresses the pain points of flexibility and responsiveness. To address the pain point of production volume limitations with individual SUBs, WuXi Biologics is continuously exploring the use of larger-volume SUBs alongside a scale-out strategy. For example, the WuXi Biologics MFG7 facility in Ireland houses twelve 4,000L SUBs, meaning it can realize flexible manufacturing at 4,000L, 8,000L, 12,000L and 16,000L, for different stages, scales and products.

By combining SUT with a scale-out strategy, we have manufactured over 300 batches at scales ranging from 4,000L to 16,000L across our global facilities, achieving a 98% success rate since 2022. During the COVID-19 pandemic, this approach enabled us to deliver tons of neutralized antibodies to GSK and AstraZeneca, showcasing the reliability of SUBs in large-scale manufacturing.

Moreover, we have completed the first commercial project Process Performance Qualification (PPQ) campaign for three sets of 5,000L individual SUBs at the Hangzhou site, and we plan to install multiple 6,000L SUBs at our Worcester site in the U.S. Even when a client's bioprocess has a low expression level of 1g/L, we can achieve a production scale of 30,000L by combining five 6,000L SUBs. Theoretically, by combining six 6,000L SUBs, the single-batch production scale can reach 36,000L, surpassing the 25,000L maximum volume limitation of a traditional stainless-steel bioreactor.

Q. WuXi Biologics has adopted a unique business model that integrates research, development and manufacturing – the ‘CRDMO’. How does this differentiate you in the manufacturing spectrum?

Chris: In today’s fast-evolving biologics market, it is increasingly important that an outsourcing partner is capable of supporting drug development across all phases. Clients benefit from streamlined services, consistent quality and – most importantly – a synergy of knowledge and technologies that can improve quality, productivity, and reduce costs along an entire drug program. We continue to achieve strong growth in manufacturing, which reflects the success of our business model and the values we’ve created.

These values are particularly tangible as molecules become increasingly diverse, and with complex modalities like bi- and multi-specific antibodies, and ADCs making up an increasingly large share of the pipeline. This requires a deep understanding of modalities, and the availability of technologies in cell line and process development and manufacturing.

There are 864 projects on our integrated platform, making it one of the world’s largest portfolios of complex biologics. Among them, over 45% are bi- and multi-specific antibodies and ADCs. We are strategically positioned to capitalize on emerging R&D trends and technologies, empowering our clients to stay ahead in the dynamic biologics industry.

Particularly for manufacturing, clients benefit from our extensive expertise in advanced technologies and process intensifications strategies, including advanced cell line development platforms, intensified culture modes, customized in-house medium formulations, and the application of PAT (Process Analytical Technology) and automation technologies to enable more precise, high-productivity process control. These are validated in the development phase and seamlessly integrated into manufacturing systems, resulting in cost reduction and enhanced efficiency.

Examples include leveraging our new WuXia^TM TrueSite cell line platform to achieve an average titer for mAbs of up to 8g/L with assured stability for scale-up. In addition, WuXi Biologics has integrated SUT with its WuXiUI™ ultra-intensified fed-batch bioprocess platform, a combination that increases productivity by 3-6 fold and drug substance output by up to 500% at a similar production scale. When used with the WuXiUP™ high-efficiency continuous perfusion manufacturing technology platform, the productivity can be 5-20 times higher than traditional fed-batch with downstream yields as high as 80-90%. These integrations can meet the manufacturing needs of any "Blockbuster" drug.

By intensifying processes, controlling pass-through costs, and utilizing capacity efficiently, we deliver the most cost-effective manufacturing solutions to global clients, regardless of the product type or development stage. Our solutions include cost control of consumables such as media and chromatography resins, as well as redevelopment of cell lines and design of high-yield processes. For example, for IND projects supported by WuXi Biologics, we can predict commercial-scale production costs based on existing processes, enabling clients to plan proactively and manage expenses efficiently.

Q: WuXi Biologics has a reputation for industry-leading timelines for IND, technology transfer and PPQ. It is said you can complete technology transfer and PPQ within 3-4 months, which is way ahead of the industry benchmark – how do you manage to achieve this?

Chris: Yes, with an accelerated schedule, the technology transfer-to-PPQ period can be reduced to just 3.5 months, well below the industry average. However, typically at WuXi Biologics, a client’s project takes 6 months to progress from technology transfer to PPQ completion, and 10 months to BLA (Biologics License Application) submission. These timelines are still 3–6 and 8–15 months shorter than industry standards, respectively. And when it comes to speed-to-market, this kind of edge can be a true game-changer.

This speed advantage stems from WuXi Biologics’ multi-dimensional strengths in technology advancements, integrated management and talents, and our service capabilities, which underpin these strengths, are worth breaking down a bit further.

From contract signing, a senior cross-functional CMC Lead and Project Manager are assigned to each client project. A dedicated CMC team is formed within 2 weeks, and the project is launched promptly within 4 weeks. The CMC Lead provides strategic and technical guidance to project teams – grounded in process technology, aligned with regulatory requirements of filing-region authorities, and compliant with ICH biopharmaceutical standards – to mitigate risks and resolve technical challenges.

The Project Manager oversees day-to-day project management, including team assembly, timeline development, and internal/external resource coordination. Strong project management and seamless client communication ensure on-time delivery. The commercial manufacturing team also includes over 800 experts spanning hundreds of disciplines. Subject Matter Experts with deep technical expertise make up over 60% of the team, while Function Leads focus on collaboration. These two roles complement each other, driving efficiency and synergy throughout manufacturing.

Q: We know that quality is the lifeline in biomanufacturing, alongside ensuring that everything complies with global regulatory standards. What do you think is key in delivering consistent high quality?

Chris: In the biopharmaceutical industry, the Cost of Poor Quality (CoPQ) is far greater than it appears. The industry likens it to an ‘iceberg of costs’ – beyond the direct economic losses to pharmaceutical companies and medication risks to patients, more indirect and intangible costs lie hidden ‘below the waterline’.

WuXi Biologics’ quality management is rooted in a proactive prevention philosophy, leveraging predictive quality management tools. Instead of a traditional reactive approach that focuses merely on meeting regulatory and client requirements, our proactive prevention approach centers on risk prevention and meaningful data. It identifies new improvement opportunities, continuously enhances quality and efficiency, and ensures product quality through concrete actions.

To underpin this philosophy, WuXi Biologics has established quality assurance (QA), quality control (QC), and operational systems that meet or exceed global regulatory standards, along with a quality management system aligned with the highest global benchmarks. These systems provide robust guarantees for product consistency, efficacy, safety and reliability across global operations. We have also obtained certifications from 12 major regulatory authorities, including the US FDA, Europe’s EMA, and China’s NMPA – laying a solid foundation for global manufacturing compliance.

Backed by a team of over 1,000 quality experts, we have maintained an exceptional track record in quality management. Since 2017, WuXi Biologics has completed 44 inspections by pharmaceutical regulatory authorities worldwide, achieving a 100% pass rate with zero critical findings and zero data integrity issues (including 22 inspections by the EMA and FDA). Meanwhile, we have successfully passed more than 1,700 client GMP/quality audits, consistently adhering to clients’ strict quality requirements and contributing to the success of their products.

Q: WuXi Biologics has built a robust global network of facilities. What arrangements have you made for critical raw material supply chains and parallel sourcing to ensure the continuity and security of manufacturing?

Chris: We’ve built a robust global network in China, the US, Ireland, Germany and Singapore, underpinned by our “Dual Sourcing Strategy” that sets us apart in the industry. This strategy allows clients to choose the site that best aligns with their market access needs, logistics preferences or timeline requirements, without compromising on quality or compliance.

Our global footprint also enables proximity to key innovation and manufacturing hubs – such as Dundalk, Ireland, where big pharmaceutical companies have established extensive manufacturing operations. Recently, our facility in Dundalk received its first approval from the EMA as a commercial manufacturing site for a global client’s innovative biologic. In Singapore, a global shipping hub and center for Asian biopharmaceutical innovation, WuXi Biologics’ CRDMO center – currently under construction – will act as a critical pivot to support the Asia-Pacific and global markets, further strengthening our robust global network.

We systematically manage a network of over 2,800 suppliers, and implement multi-source procurement to minimize reliance on any single supplier. Meanwhile, we continuously refine our safety stock calculation models, ensuring all projects can be launched within 4 weeks, and we remain deployment-ready at all times. Additionally, we conduct comprehensive supplier audits to guarantee full compliance with relevant regulations.

Q: As biotech and large pharmaceutical companies raise requirements for R&D efficiency, how should the core competitiveness of future CDMOs reflect the value of an "innovation partner"?

Chris: First, continuous innovation capability remains core to a CRDMO like WuXi Biologics. Our client base and project pipeline have grown rapidly – an outcome driven by our relentless pursuit of technological advancement. We have deployed cutting-edge technology platforms across the entire drug lifecycle, which enhance product potency, boost cell line titers, and improve stability and scalability. Through innovation, we translate technological progress into stronger clinical-stage molecules, faster concept-to-market timelines, and lower long-term manufacturing costs.

We continue to upgrade our existing technology, and 2025 has seen the launch of multiple innovative platforms. To name just a few: the fourth generation of our flagship CHO cell line platform WuXia™ TrueSite, which leverages targeted integration technology to streamline clone screening and ensure expression stability; WuXia293^Stable, a HEK 293 cell line platform designed for difficult-to-express molecules; and WuXiHigh™ 2.0, a high-throughput formulation development platform capable of achieving protein concentrations of up to 230mg/mL.

Furthermore, amid rapid changes in the global biopharmaceutical market, enhancing flexibility to respond more quickly to client needs has become critical. This includes flexible capacity allocation, accelerated development timelines, and rapid process scale-up capabilities.

Winners in the future will be companies that can serve as true long-term innovation partners for pharmaceutical companies, rather than merely functioning as "service providers." CRDMOs create value for clients by integrating core capabilities – vertical sector expertise, cutting-edge technologies, and accumulated project experience. We are not just "lending an extra hand"; we become an extension of our clients’ capabilities, whether they are large pharma companies or smaller emerging biotechs. In doing so, we make their pursuit of life-saving drugs easier and faster.

Editor’s Note

For more information, or to arrange interviews, please contact Tristan Jervis at Impact Shine Communications on +44 (0) 771 363 8396 or e-mail t.jervis@impactshinecommunications.com

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2025, WuXi Biologics is supporting 864 integrated client projects, including 24 in commercial manufacturing.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.