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PawBio

One-stop solution for superior
animal health outcomes

PawBio

 

WuXi Biologics brings its renowned quality and experience to animal health. From U.S. to China, our globe-spanning network supports drug substance (DS) and drug product (DP) research, development, and manufacturing so you can commercialize drugs for companion animals with similar quality of human care. At the heart of this mission is an advanced technology platform that accelerates progress, reduces costs, and delivers impactful results. By bridging human healthcare experiences with breakthrough innovations, you can unlock the full potential of human-animal translation.

 

 

Single-source technology

From concept to commercialization, reduce both the time-to-clinic and project risks with the use of our technology platforms, such as WuXiaTM, WuXiUPTM, WuXiUITM, etc.

 

Dual supply sites 

Facilities in the U.S. and China advance the manufacturing of veterinary medicine to meet the standards of USDA, FDA, EMA, and other global agencies.

Effective cost management

Unite innovative technology and manufacturing excellence through established processes that increase productivity while decreasing the cost of goods sold (COGS).

Global regulatory filing

A robust registration experience supports the filing of animal health products with global regulatory authorities.

 


What we offer

 

Companies entering the animal biologics industry face unique challenges. Navigating a complex regulatory landscape, coupled with lower revenue potential compared to human biologics, demands careful cost management. Competition for resources with contract development and manufacturing organizations (CDMOs) that prioritize human health further complicate the path forward.

 

WuXi Biologics addresses these challenges head-on. We support global clients from pharmaceutical companies, biotechnology companies, and academic institutions, with expert regulatory guidance and an advanced production system that ensures cost-effective production. From cell line development through commercial supply, our streamlined programs are designed to start quickly and ensure your animal health products reach the market efficiently. Our approach emphasizes flexibility, quality, and execution excellence at every stage, tailored to meet your unique needs.

 


Research

WuXi Biologics brings deep expertise, modern facilities, and advanced antibody generation to PawBio, supporting your discovery of innovative veterinary biologics. Every research activity employs top-tier technology for optimal outcomes.

  • Project preparation
    • Antigen design
    • Tool cell line engineering
  • Antibody generation
    • Single B cloning
    • Phase-displayed
    • Hybridoma
  • Lead optimization
    • Developability improvement
    • PETization
    • Affinity maturation*
  • In vitro and in vivo evaluation
    • Molecular, biochemical, and cellular assay efficacy
    • PK/PD models
    • Exploratory toxicology models*

*And more

Development

Our fully integrated service model streamlines biologics development. This approach allows us to expedite timelines, ensuring faster delivery of high-quality products. PawBio adapts established technology to suit animal health products and offer a more cost-effective development process than legacy solutions.

 

  • Developability assessment
  • Cell line development
  • Upstream cell culture process development
  • Downstream purification process development
  • Formulation and DP process development
  • Non-GMP pilot production
  • Biosafety testing
    • Cell bank characterization
    • Unprocessed bulk
    • Viral clearance validation

Manufacturing

Our dual-site manufacturing optimized operations between U.S. and China to best meet the regulatory requirements of global animal health authorities. With a dedicated facility in China and U.S.-based biologics manufacturing, we provide comprehensive support for PawBio, including USDA coverage. Our quality system is certified by 21 regulatory agencies, including FDA, EMA, NMPA, and PDMA.

 

  • Cell banking
  • DS and DP manufacturing
  • DS and DP stability studies
  • Clinical supply service solutions
  • INAD and BLA package
  • INAD and BLA filling

Analytics

With unmatched expertise in method life-cycle management, cutting-edge technology platforms, and a comprehensive range of analytical methods, WuXi Biologics delivers exceptional capability and capacity for highly efficient execution.

 

  • Product characterization
  • Method development and qualification
  • Non-GMP and GMP product release
  • Non-GMP and GMP product release stability study

 

Related Resources


Effective COGS control case study
Animal Health Biologics Service Overview Flyer

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