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Process Development & Scale Up

With extensive facilities and highly-trained personnel and a global presence across two continents, we are fully equipped to meet the needs of our clients worldwide. Our capabilities include supporting early-stage and late-stage development for both mammalian and microbial systems, as well as various product modalities and process modes, ensuring flexibility and adaptability to your specific requirements.

Experienced team

~1000 scientists and process engineers

Proven track record

500+ developed processes scaled up to manufacturing

Reliable pilot production

Success rate exceeding 99% in over 1200 pilot drug substance production batches

Efficient timelines

2-3 mths – early-stage development, 3-5 mths – commercial process development, 4-8 mths – process characterization

Multiple development laboratories and facilities

5 sites in US and Asia

Regulatory expertise

~500 IND approvals and 30+ market authorizations

Partner with us for your biologics process development and scale-up needs

Benefit from our global presence, experienced team, efficient timelines, regulatory expertise, and comprehensive support.
Contact us today to discuss how we can bring your biologics projects to fruition.

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Key Features

The Upstream Process Development Department (CCPD) at WuXi Biologics is at the forefront of implementing diverse cell culture modes to meet the unique needs of our clients. Our capabilities include TFB (traditional fed batch), IFB (intensified fed batch), CFB (concentrated fed batch), and perfusion cell culture, along with our novel WuXiUPTM (ultra-high productivity continuous bioprocessing), WuXiUITM (ultra-intensified fed-batch) platforms for ultimate flexibility to meet your project goals.

Whether you have a small independent study or an more extensive integrated IND or a later-stage process development project, our team is equipped to handle it efficietly with right-the-first-time project execution abilities. Our team utilizes a variety of state-of-the-art cell culture bioreactor systems and cutting-edge analytical equipment to ensure the success of your upstream process development, optimization, and characterization.

  • Bioreactors ranging from 3 to 15 liters
  • Finesse
  • Applikon control system
  • Wave-type disposable bioreactors
  • High-throughput process development in ambr250 or ambr15 systems
  • Perfusion and concentrated fed batch culture platforms leveraging ATFTM technology, and the Cedex Bio HT high-throughput bioanalyzer.

WuXi Biologics provides downstream process development which applies state-of-the-art technology to purification process development, process scale-up, and process characterization. The team also supports technology transfer to cGMP production activities at all phases. DSPD has extensive experience developing downstream processes across a myriad of purification unit step operations for a wide-variety of biologics including: monoclonal antibodies, bispecific antibodies, Fc-fusion proteins, antibody drug conjugates, recombinant proteins and enzymes.

Expertise is available for the development of multiple downstream technologies and unit step operations at both clinical and commercial scale:

  • Product capture (chromatography resins/membranes)
  • Viral inactivation (e.g., low/high pH, solvent)
  • Purification and polishing chromatography (chromatography resins / membranes)
  • Concentration or Buffer Exchange (e.g., Ultrafiltration / Diafiltration / Tangential Flow Filtration)
  • Viral clearance (e.g., nanofiltration)

Our team delivers high-quality and robust downstream processes in a competitive timeline. Our scientists are highly-trained, maintain comprehensive knowledge and skillsets and in-depth project related experience in downstream process development, which enabled us to develop over 500 downstream processes for clinical and commercial production.

Non-GMP Pilot Production (NPP) provides customers with comprehensive biopharmaceutical drug substance process scale-up and non-GMP material generation services, currently operating in 5 sites (Shanghai, Waigaoqiao district, Shanghai, Fengxian district,  Wuxi, Mashan distict, Cranbury, NJ, and King of Prussia, PA) across two countries.

NPP boasts advanced upstream and downstream facilities featuring state-of-the-art equipment to supports various cell culture modes. Our upstream cell culture capabilities include single-use bioreactors from HyPerforma S.U.B, HyPerforma DynaDrive S.U.B, Biostat STR, Xcellerex XDR, and Mobius at 50 L to 500 L scale.  These systems provide for diverse scale-up evaluations, and are supported by well-established platform strategies. For downstream purification, we have the BioSMB Process 80 for continuous direct product capture, multiple ÄKTA systems for chromatography unit step operations, and other purification options. With a success rate of >99%, we have delivered over 1,200 drug substance batches.

Service Highlights

The WuXiUPTM Ultra-High Productivity bioprocessing platform has broken through the time and titer barrier with 5-10x productivity compared to traditional fed-batch processes. WuXiUP is a fully integrated continuous process capable of generating ~6 g/L/day productivity and delivering over 60 kg protein per batch from a 1,000 L disposable bioreactor, – which is comparable to the yield coming from a single 10,000 L – 20,000 L stainless steel bioreactor.

Over 130 successful WuXiUP processes across 50 different molecules have been developed, with >20 processes scaled up to GMP manufacturing and included as part of successful IND and BLA submissions.

WuXi Biologics’ proprietary WuXiUI ultra-intensified fed-batch bioprocessing platform aims to revolutionize upstream process performance, by offering enhanced productivity and reduced cost of goods (COGS) in commercial manufacturing with unparalleled flexibility.  Through extensive application in over 26 cell lines expressing various recombinant proteins such as mAbs, bispecific antibodies, and fusion proteins, our platform consistently achieves 3-6 times higher upstream productivity compared to conventional fed-batch processes.

WuXi Biologics has created in-house cell culture media and established a state-of-the-art media development platform to provide our clients both high-quality and cost-effective media for eventual use in clinical and commercial production. We have developed a library of chemically defined in-house media that are compatible with a wide range of host parental cells, process modes, and product modalities.  These in-house media have demonstrated superior performance and cost competitiveness compared to leading commercial cell culture media. Additionally, our development platform leverages intelligent formulation design, media powder evaluation, and high-quality qualification procedures to provide rapid and targeted media optimization for our clients.

The WuXiHighTM platform offers tailored strategies for developing drug substance and drug product formulations with high concentrations (up to 200 mg/mL), applicable across a wide-range of biologics. The platform provides customized UF/DF processes, unique viscosity reducers and synergistic excipient combinations to improve formulation stability and lower viscosity. 

WuXiHigh offers a development toolbox to mitigate high pressure, low yield, pH/excipient shift, and aggregation generation during UF/DF operations. The platform also incorporates advanced computer simulation technologies like homologous modeling, molecular dynamics simulation, and machine learning. This integration streamlines formulation development, leveraging computational simulation results, high-throughput experimental screening, and experimental validation to enhance efficiency and reduce risk during high concentration product drug product development.

Our PD services implement multiple process analytical technologies (PATs) to provide efficient, accurate and robust development of standalone or integrated upstream and downstream unit step operations.  One of the key PAT tools utilized is our advanced Raman-based process analysis systems, which have been implemented across PD to GMP production at  scales ranging from 3L to 2,000L. These systems (e.g., AKTA pcc 75, BioSMD PD) include real-time monitoring and intelligent development design to help reduce costs, enhance efficiency and achieve robust large-scale manufacturing.

We utilize our advanced central control system and PAT tools to debottleneck the productivity gap between upstream intensified processes and conventional batch mode downstream processes. The tools also support the development of stand-alone processes such as an independent continuous capture (CC) step to end-to-end integrated processes (e.g., cell culture seed train to DS bulk).

From early-stage process development to late-stage process characterization, we provide customized cell culture and purification processes using the latest high-throughput and automation systems.  Using these advanced systems we can effectively accelerate our clients’ DNA to IND to BLA product development timelines.


Of the various high-throughput, automated systems we employ are two, 24/7 unmanned automated bioreactor smart labs and Ambr 15TM and Ambr 250TM systems (including an Amber 250TM perfusion mode module) to enable efficient clone screening and process optimization across diverse cell culture modes.  A TECAN Liquid Handling System is also applied for high-throughput purification process screening, especially for difficult-to-purify molecules. These various platforms allow us to develop and optimize multiple processes in parallel, leading to faster scale-up for production and to establish a timeline from DNA to final clone in just 9 weeks.

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