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Drug Product Development

End-to-End Biologics Drug Product CDMO Services

WuXi Biologics’ drug product development services address complex formulation challenges, reduce development risks, and accelerate timelines across all clinical stages from early development through commercial manufacturing. We specialize in the development of clinical and commercial programs with expertise in:

  • Liquid, frozen, and lyophilized dosage forms
  • Container closure systems (CCSs) such as vials and pre-filled syringes (PFSs)
  • Drug-device combination products, including PFSs, safety PFSs, and auto-injectors
  • Global clinical supply services

We act as a trusted partner to help you overcome technical barriers, streamline development, and achieve high-quality outcomes.

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Comprehensive Capabilities for Drug Product

Our integrated capabilities are designed to overcome key drug product development hurdles, including solubility, stability, fill-finish compatibility, and regulatory readiness:

  • Formulation development at protein concentrations from 1.5 µg/mL to 230 mg/mL using the WuXiHigh™ 2.0 technology platform
  • Integrated high-throughput and automation instrumentation that accelerates your path to BLA
  • Development of liquid, lyophilized, and frozen dosage forms
  • Drug product process development for standard and ready-to-use (RTU) vials and PFS
  • Capabilities spanning early-stage R&D formulation development through late-stage final formulation lock, process characterization, qualification, and validation
  • Suitable for both large pharmaceutical corporations and early-stage companies

WuXi Biologics’ Drug Product Development Program

Drug product development begins with early-stage developability assessments to avoid costly setbacks later in the lifecycle. Our expert team supports formulation optimization across a wide range of biologics and vaccine formats:

  • Monoclonal antibodies (mAbs), bispecific antibodies (BsAb), and multispecific antibodies
  • Fc-fusion proteins and other recombinant proteins
  • Antibody fragments like Fab and single-chain variable fragment
  • Viral and virus-like particle (VLP) products
  • Nucleic acids: plasmid DNA (pDNA), messenger RNA (mRNA), and oligonucleotides
  • Antibody-drug conjugates (ADCs) and other bioconjugates

Specialized services include:

  • Early-stage developability assessments
  • Optimal formulation identification using DoE or one-factor-at-a-time approaches
  • High-throughput biophysical screening (dynamic light scattering, differential scanning calorimetry, differential scanning fluorimetry, and more)
  • In-use compatibility studies to support clinical dose preparation, storage, and administration
  • Forced degradation and stability studies for shelf-life assessment
  • Shipping simulation and validation for stability in transit
  • E&L studies to assess packaging interaction
  • Filter validation

We tailor high-throughput formulation development for high-concentration biologic drug products. WuXiHigh 2.0 delivers custom formulation strategies for concentrations up to 230 mg/mL while minimizing formulation risk and accelerating the path to clinic or market.

Key Features

  • Supports monoclonal, bispecific, and multispecific antibodies, fusion proteins, and other modalities
  • Incorporates proprietary excipients and viscosity reducers
  • Integrates simulation technologies: homologous modeling and molecular dynamics
  • Combines computational modeling, high-throughput experimental screening, lab verification

Tools and Capabilities

  • High-throughput systems: UNcle, RheoSense, DLS, and low-field nuclear magnetic resonance
  • Tailored process development for drug substance and drug product
  • Viscosity handling up to 50 cP
  • Over 100 high-concentration projects completed with a deep knowledge base

WuXi Biologics scientists tailor formulations for phase-appropriate performance, and also for compatibility with your preferred CCS, reducing the risk of late-stage incompatibilities.

CCS Options

  • Ready-to-store and RTU vials: 2R, 6R, 8R, 10R, 14R, 20R, 50R sizes
  • PFSs: 1 mL long, 1 mL standard, 2.25 mL, and 3 mL formats; staked needle, Luer lock design
  • Safety PFSs: PFS with a passive needle safety device (NSD)
  • Auto-injectors with a user-friendly design
  • Pilot, clinical, and commercial GMP manufacturing across all CCS types and scales

Our drug product development experts streamline fill process development, scale-up, and characterization, helping you avoid costly rework and accelerate time to GMP production.

Backed by automated, advanced fill-line technologies, WuXi Biologics provides a full suite of services for process development and technology transfer. We support RABS, isolator-based lines, and Vanrx systems, including:

  • End-to-end fill process development: drug substance thawing to drug product visual inspection
  • Lyophilization cycle development and optimization
  • Pilot-scale fill-finish and lyophilization for preclinical and stability studies
  • Container and closure selection and integrity testing

With rising chronic disease and at-home care trends, patient-friendly drug delivery systems are essential. Combination products such as PFSs with NSDs and auto-injectors enhance adherence and safety.

WuXi Biologics offers the expertise and infrastructure to design and develop delivery systems aligned to your product, patient, and regulatory needs.

Passive Systems

  • Syringes: 1 mL long, 1 mL standard, 2.25 mL, 3 mL; staked needle or Luer Lock
  • Plunger stoppers: 1 mL long and 1–3 mL; available nested or rapid transfer port bag
  • Fill volumes: 0.15 to 3 mL
  • Flange types: cut, round, small round, extended
  • Customization: color, material, plunger rod, flange

Auto-Injectors

  • Collaboration with leading syringe and auto-injector vendors
  • Evaluation of standard and client-specific designs
  • Human factor testing and final assembly support

WuXi Biologics’ Center of Excellence for technology transfer brings together drug product CDMO experts and GMP manufacturing teams. Their close collaboration ensures a seamless, efficient transition from late-stage development to commercial production—reducing delays and de-risking global supply planning.

After technology transfer, we apply unified, single-source process technologies to deliver streamlined GMP manufacturing solutions. Our global network includes automated and isolator-based production capabilities, supported by robust quality systems. Twelve global regulatory agencies have audited these systems, and clients have validated them through more than 760 successful quality audits.

We operate 11 GMP drug product facilities with capacity exceeding 100 million vials and 30 million PFSs annually. Several sites use Vanrx—a robotic, isolator-based system ideal for aseptic small- to medium-scale batches.

Our analytical teams support every stage of the drug product CDMO lifecycle, from first-in-human formulations to final validation. Advanced in-house tools and methods accelerate timelines.

Supported by deep expertise and a global GMP network, WuXi Biologics delivers clinical supply services that reduce complexity, ensure chain-of-custody, and meet tight study timelines.

Included Services

  • Labeling: precision clinical labeling
  • Secondary packaging: custom, blinded, or patient kit-ready formats
  • Warehousing: GMP and multi-temperature with GPS-tracked logistics
  • Returns, reconciliation, and destruction
  • Comparator drug sourcing

Benefits

  • GMP expertise: leading clinical supply services operator in China
  • Single-sourcing: from drug substance through Phase III
  • Cold chain: custom incubators and temperature monitoring
  • Global reach and dependable supply chain execution

Connect with our experts today to learn how we can advance your project. For deeper insights, please explore our publications and scientific posters.

Related Resources

[Infographic] WuXiHigh 2.0 in Action

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[Technology Brief] Stabilize Proteins and Reduce Viscosity with WuXiHigh 2.0 for High-Concentration Biologics

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[Service Overview] Drug Product Development

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