WuXi Biologics accelerates development, manufacturing with robust model, platforms

The contract research, development and manufacturing organization (CRDMO) industry has advanced rapidly over the past decade. In particular, growth in biopharma capabilities reflects the increasing number of drug developers choosing to partner and collaborate with CRDMO companies able to provide flexible solutions that deliver complex modalities, quickly, and reliably.  

WuXi Biologics is a top-tier CRDMO that is helping biopharma companies stay ahead of rapid developments in the sector. At the recent J.P. Morgan Healthcare Conference, WuXi Biologics highlighted strong overall project growth, with bi‑and multi-specific programs emerging as the company’s fastest‑growing engine, now reaching 196 projects in the pipeline. The company also announced the expansion of its global network into the Middle East last December.  

In this Q&A, Dr. Chris Chen discusses the WuXi Biologics approach, including insights into their highly advanced technology platforms that may well be a cornerstone for achieving high quality biologics development and manufacturing.  

WuXi Biologics has adopted a unique model that integrates research, development and manufacturing — the CRDMO. How does this differentiate you?  

Chen: In today’s fast-evolving biologics market, we believe that it is increasingly important that an outsourcing partner is capable of supporting drug development across all phases. This enables streamlined services, consistent quality and — perhaps most importantly — a synergy of expertise and technologies, together with a deep understanding of modalities, combining to improve quality, productivity, and reduce costs across an entire drug program.  

Clients’ programs, especially those highly challenging complex molecules, benefit from our advanced technologies, such as a new cell line development platform, 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 of each project, and seamlessly integrated into manufacturing systems, resulting in cost reductions and enhanced efficiencies. We leverage these tools to deliver the most cost-effective manufacturing solutions to global clients, regardless of the development stage. 

There are 945 projects on our integrated platform, and bispecific/multi-specific antibody and ADC projects continuing to expand rapidly, with each growing by approximately 30% to reach 196 and 252 projects, respectively. Together, these complex modalities now account for nearly 50% of the total pipeline. This reflects the success of our business model and the values we’ve created. We are strategically positioned to capitalize on emerging R&D trends and technologies, empowering our clients to stay ahead in the biologics industry. 

How do you ensure that level of expertise for every project? 

Chen: From contract signing, a senior cross-functional Chemical, Manufacturing, and Controls (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 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 quality and efficiency throughout manufacturing. 

What do you think is key in delivering consistent high quality?  

Chen: Our quality management is rooted in a proactive prevention philosophy, leveraging predictive quality management tools. This approach centers on risk prevention, the identification of new improvement opportunities, continuous enhancement of quality and efficiency, and ensuring product quality through concrete actions. 

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.  

Besides the rigorous quality system, we’ve also established digital technologies like electric batch records (EBR), and computational modeling and analytics to ensure data integrity and quality assurance.  

As a result, we have obtained certifications from 12 major regulatory authorities, including the U.S. 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, WuXi Biologics has completed 46 inspections by pharmaceutical regulatory authorities worldwide since 2017, achieving a 100% pass rate with zero critical findings and zero data integrity issues. We have also successfully passed more than 1,800 client GMP/quality audits, consistently adhering to strict quality requirements. 

As biologics expand across diverse indications and innovative therapies, production needs are becoming more varied. How is the industry responding to these fluctuations, and what strategies ensure flexibility and cost efficiency? 

Chen: This is one of the key pain points in our industry right now. Fluctuating demand is now the norm, and a higher proportion of products are needed in relatively small volumes. 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. We have successfully run more than 2,000 batches using our 2,000L, 4,000L, and 5,000L SUBs, achieving a success rate of 99.5%. 

We also apply a scale-out strategy, using several SUBs simultaneously to produce higher volumes. 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. Added to the fact that a scale-out strategy can achieve industrial-scale results, production can be significantly accelerated, as we can circumvent the challenges of process scale-up. We have run over 300 batches at scales ranging from 4,000L to 16,000L across our global facilities, achieving over 98% success rates.  

Furthermore, the integration of our proprietary technology platforms (e.g., WuXiUI, WuXiUP) can bring even further productivity with reduced costs. Our WuXiUI ultra-intensified fed-batch bioprocess platform, when integrated with SUT, 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%. 

Can you tell us more about these technology platforms that WuXi Biologics is developing and leveraging to enhance product development and delivery?   

Chen: Continuous innovation capability remains core to a CRDMO like WuXi Biologics. 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. We translate technological progress into stronger clinical-stage molecules, faster concept-to-market timelines, and lower long-term manufacturing costs.  

The past few months saw the launch of multiple innovative platforms. To name just a few: the fourth generation of our flagship cell line platform WuXia TrueSite, an industry-leading targeted integration (TI)-based CHO cell line platform designed to reshape biologics development by accelerating timelines, enhancing product quality, and ensuring consistent scalability for antibody and complex protein therapies. The platform has achieved an average mAb titer exceeding 8.0 g/L, with over 99% of clonal cell lines maintaining stable protein expression after passaging for 60 generations, and shortened cell line development to 2.5 months (from 4 to 5 months). High-dose solutions, including high-throughput formulation development platform WuXiHigh, are capable of achieving protein concentrations of up to 230mg/mL and Hyaluronidase Co-Formulation.

We also launched a digital twin platform PatroLab, which combines advanced real-time process monitoring with Raman-based PAT and predictive in silico modeling to enhance process performance, shorten development timelines, and ensure consistent, high-quality biologics manufacturing. 

How does all this translate into accelerated timelines and a “better” partnership? 

Chen: We have shown that, by applying our end-to-end platform at scale, our advanced technology platforms, and agile service teams, the technology transfer-to-PPQ period can be reduced to just 3.5 months, which is well below the industry average. 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. This kind of innovative edge can be a true game-changer.  

It is our firmest belief that — in order to maintain a leading position in this industry — we must continue to serve as true long-term innovation partners for pharmaceutical companies, rather than merely functioning as a “service provider.” CRDMOs like WuXi Biologics strive to 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 emerging biotechs. In doing so, we make their pursuit of life-saving drugs easier and faster.