Animal Health Biologics

Flexible Support across the Product Lifecycle

PawBio serves pharmaceutical companies, biotechnology firms, and academic institutions worldwide. Whether initiating a new program or preparing for commercialization, clients can access support at any point during research, development, manufacturing, and regulatory strategy. Our integrated services are designed to launch quickly, progress efficiently, and adapt to evolving needs.

Research Services

PawBio supports early-stage discovery with high-performance tools and facilities. Services include protein and antibody generation in quantities ranging from microgram to gram, suitable for screening, functional testing, and candidate development.

From project preparation to in vitro and in vivo evaluation, advanced technologies and quality-focused processes power all research activities. Reliable outcomes and reduced downstream risk are key goals.

Process Development

PawBio adapts WuXi Biologics’ platform-based development model to suit the unique demands of an animal health biologic. This approach forges a more streamlined, cost-effective pathway than traditional methods.

In-house expertise and flexible options that simplify technology transfer and scale-up support each program. Comprehensive biosafety testing—including cell bank characterization, viral clearance studies, and unprocessed bulk release testing—ensures product safety and regulatory alignment.

GMP Manufacturing

PawBio offers dual-site GMP manufacturing across the US and China, allowing global reach and regulatory alignment. In China, manufacturing capacity includes support for animal health programs, enhancing US-based biologics production for global registration needs. Twenty-one regulatory authorities, including FDA, EMA, NMPA, PDMA, and USDA, have certified our global network of drug product and manufacturing sites.

With over 400 successful technology transfers in both human and animal health, PawBio streamlines development-to-manufacturing transitions, delivering speed without compromising quality. Capabilities include:

• Cell banking
• Drug substance and drug product manufacturing
• Drug substance and drug product stability studies
• Clinical supply service solutions
• IND and BLA filing

Regulatory Strategy

PawBio provides end-to-end regulatory support, offering strategic guidance and submission preparation aligned with global and regional requirements. Services cover IND, BLA, and USDA submissions and documentation aligned to the standards of EMA and other authorities.

PawBio provides end-to-end regulatory support, offering WuXi Biologics’ industry-recognized quality systems, environmental controls, and certifications to reinforce our regulatory support. PawBio also reflects WuXi Biologics’ commitment to environmental, social, and governance (ESG) standards.

Technology Platforms That Deliver More

WuXi Biologics’ proprietary technology platforms form the foundation of PawBio’s development and manufacturing abilities. These modular systems combine tools, processes, and technical expertise to drive speed, scalability, and quality across diverse modalities.

Frequently Asked Questions