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Breakthroughs in Every Drop: Introducing WuXiHigh™ 2.0 for High-Concentration Biologics

Break the Viscosity Barrier Up to 230 mg/mL

WuXiHigh 2.0 is transforming biologics drug development for high-concentration formulations. This next-generation technology platform advances solutions that overcome viscosity and enable seamless scale-up. Combining innovative science with deep expertise in drug product formulation, fill-finish, and drug device combination products. WuXiHigh 2.0 helps innovators accelerate development and bring therapies to patients more efficiently.
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Redefining the Standard

While the highest FDA-approved biologic concentration stands at 200 mg/mL, WuXiHigh 2.0 has achieved 230 mg/mL—establishing a new benchmark. That added concentration translates to greater flexibility in injection volume, which can reduce dosing frequency, ease cold-chain logistics, and enhance drug substance manufacturing and drug product manufacturing efficiency.
MetricIndustry StandardWuXiHigh 2.0
Protein required50–60 g≤ 20 g
Screening scale12 formulations24 formulations
Screening timeline3.5 months8 weeks or less
Viscosity reduction~20%up to 90%
Excipient options5 common24 unique
Filling accuracy≤ 20 cP at 5%≤ 50 cP at 4%

Fast-Tracked Formulations

Whether you are developing monoclonal antibodies, bispecifics, Fc fusions, ADCs, vaccines, or biosimilars, traditional formulation screening can be slow and inefficient. WuXiHigh 2.0 breaks this cycle with high-throughput techniques that conserve protein, expand formulation options, and compress development timelines. Leveraging low-field NMR, dynamic light scattering, and other modern tools, the platform minimizes cost while accelerating time-to-clinic.

Tackling Viscosity Head-On

High concentration often leads to formulation problems: increased viscosity, formulation instability, and painful injection. Standard excipients offer only limited help. WuXiHigh 2.0, in contrast, uses over 24 proprietary excipient combinations to significantly reduce viscosity—by up to 90%—while maintaining formulation stability and injectability. Fully integrated solutions for lyophilized pharmaceuticals or the manufacturing of prefilled syringes or other drug-device combination products matches the formulation to its ideal format. The result: enhanced patient comfort without compromising drug performance.
Tackling Viscosity Head-On
Designed for Scale

Designed for Scale

As high-concentration biologics scale from development to commercial production, high viscosity clogs filters, increases pressure, and creates filling challenges that drive up costs. WuXiHigh 2.0 is built to overcome these bottlenecks. With robust filling processes, the platform delivers precise, reliable performance—even under high-viscosity conditions. WuXi Biologics’ facilities can fill formulations with viscosities up to 50 cP while achieving 4% accuracy. Our ultrafiltration and diafiltration processes also enable the seamless manufacturing of high-concentration drug substance.

Your Partner throughout the Drug Product Development Process

Whether you are initiating biologics formulation development or seeking clinical supply services, WuXi Biologics drug product development provides the scientific rigor and CDMO support to help you succeed. From the formulation development process to drug formulation process, biological product manufacturing, and end-to-end clinical supply services, we meet the needs of those pushing the limits of innovation.

Related Resources

WuXiHigh 2.0 InfographicLearn More