Infectious Diseases
Accelerating Infectious Disease Drug Discovery
The emergence of novel pathogens, antimicrobial resistance, and increasingly complex therapeutic approaches continues to reshape infectious disease drug discovery. Successful programs require clinically relevant disease models, translational biomarkers, and integrated pharmacology to evaluate efficacy, mechanism of action, resistance, and safety across diverse pathogens and therapeutic modalities.
WuXi Biology and Testing provides an integrated discovery platform that supports antiviral, antibacterial, antifungal, and vaccine development, from target validation through candidate selection to IND-enabling studies. Our capabilities combine discovery biology, DMPK, bioanalysis, and safety assessment to help accelerate the development of innovative therapies for infectious diseases.
By the Numbers
Projects Per Year
Bacterial & Fungal Species
In Vivo Infection Models
Addressing Emerging Infectious Disease Challenges
Developing effective therapies for infectious diseases requires more than demonstrating anti-infective activity. Drug candidates must achieve sufficient exposure at the site of infection, overcome resistance mechanisms, engage diverse pathogen variants, and translate successfully from preclinical models to the clinic.
WuXi Biology and Testing integrates infectious disease pharmacology with translational biomarkers, PK/PD evaluation, bioanalysis, and safety assessment to support informed decision-making throughout drug discovery. Our platform combines disease-relevant models, mechanism-of-action studies, resistance profiling, and comprehensive pharmacology across viral, bacterial, and fungal infections to accelerate candidate selection and reduce development risk.
Supporting Diverse Anti-Infective Therapeutic Modalities
Challenges
Identifying pathogen-specific targets and optimizing compounds that demonstrate potent antimicrobial activity while minimizing resistance and off-target effects.
Solutions
- Target identification and validation
- Biochemical and cell-based screening assays
- Antiviral, antibacterial, and antifungal activity assays
- Mechanism-of-action studies
- Serum shift and drug combination
- Resistance profiling
- Hit-to-lead optimization
Challenges
Demonstrating target engagement, immune activation, or pathogen neutralization while addressing modality-specific mechanisms of action.
Solutions
- Antigen and target characterization
- Cell-based infection and neutralization assays
- Resistance profiling
- Immunogenicity assessment
- Vaccine evaluation
- Gene and protein expression analysis
- Translational biomarker identification
Challenges
Demonstrating efficacy against clinically relevant pathogens while establishing exposure-response relationships and overcoming antimicrobial resistance.
Solutions
- In vitro, ex vivo, and in vivo infection models
- MIC and MBC determination
- Time-kill studies
- Combination and synergy studies
- PK/PD evaluation
- Translational biomarker assessment
Challenges
Evaluating immune-mediated efficacy, pathogen neutralization, and durable pharmacodynamic responses in translational infection models.
Solutions
- Vaccine efficacy studies
- Neutralization assays
- In vivo challenge models
- Immunogenicity assessment
- Biomarker-driven pharmacology
- Candidate comparison using integrated efficacy and PK data
Challenges
Characterizing exposure while optimizing ADME properties, tissue distribution, and PK/PD relationships to support dose selection.
Solutions
- In vitro ADME studies
- Pharmacokinetic studies
- LC-MS/MS bioanalysis
- Metabolite identification
- PK/PD modeling
- Tissue distribution analysis
Challenges
Understanding exposure, biodistribution, immunogenicity, and pharmacodynamic activity to support clinical translation.
Solutions
- Ligand-binding bioanalysis
- ADA and immunogenicity testing
- Biomarker assays
- Biodistribution studies
- PK/PD integration
- Clinical virology support
Challenges
Establishing safety margins while supporting progression into IND-enabling studies.
Solutions
- General toxicology
- Safety pharmacology
- Clinical pathology
- IND-enabling toxicology studies
Challenges
Addressing modality-specific pharmacology, immunogenicity, and safety requirements before first-in-human studies.
Solutions
- Integrated safety assessment
- Immunogenicity evaluation
- Bioanalysis and biomarker testing
- GLP toxicology studies
- Regulatory support for IND-enabling programs
Infectious Disease Models Across Diverse Pathogens
Successful anti-infective drug discovery depends on selecting disease models that accurately reflect pathogen biology, host responses, and clinical disease progression. Our platform supports discovery programs for viral, bacterial, and fungal infections using complementary in vitro, ex vivo, and in vivo models to evaluate therapeutic efficacy and mechanism of action.
Capabilities include:
- Viral infection models
- Bacterial infection models
- Fungal infection models
- Host-pathogen interaction studies
- In vitro, ex vivo, and in vivo pharmacology
- Disease-specific efficacy models
- Histopathology and tissue analysis
- Translational disease biology
Clinical Virology and Microbiology and Translational Evaluation
Generating clinically relevant preclinical data requires more than demonstrating pathogen inhibition. Our infectious disease platform integrates microbiology, virology, molecular analyses, bioanalysis, and translational biomarkers to characterize therapeutic activity, support mechanism-of-action studies, and strengthen confidence in clinical translation.
Capabilities include:
- Clinical virology testing
- Clinical microbiology testing
- Viral load and pathogen burden analysis
- Clinical strain isolation and susceptibility test
- Molecular biomarker analysis
- Immunological biomarkers
- Bioanalysis and PK/PD biomarkers
- Mechanism-of-action studies
Addressing Antimicrobial Resistance
The continued emergence of antimicrobial resistance demands new strategies for evaluating anti-infective therapies. Our platform combines susceptibility testing, resistance profiling, and PK/PD-guided pharmacology to help optimize drug candidates, evaluate combination therapies, and support the development of treatments effective against resistant pathogens.
Capabilities include:
- Strain engineering
- MIC and MBC determination
- Time-kill studies
- Post antibiotic effect
- Drug combination and synergy studies
- Resistance profiling
- Clinical isolate testing
- PK/PD-guided efficacy evaluation
- Mechanism-of-action analysis
- Candidate optimization
Related Services
Discovery Biology
Advance drug discovery with integrated target biology, pharmacology, disease models, and translational research.
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DMPK
Optimize drug candidates through integrated ADME, pharmacokinetics, metabolism, and PK/PD studies.
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Bioanalysis
Generate high-quality PK, biomarker, immunogenicity, and bioanalytical data throughout drug development.
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Safety Assessment
Support confident development with integrated toxicology, safety pharmacology, pathology, and IND-enabling studies.
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Frequently Asked Questions
Infectious diseases are illnesses caused by bacteria, viruses, fungi, parasites, or other microorganisms. Some infections are mild and self-limiting, while others can become severe or life-threatening, particularly in vulnerable populations.
Pathogens continually evolve, leading to antimicrobial resistance, genetic variation, and emerging infectious threats. Developing effective therapies requires understanding both pathogen biology and the host immune response while demonstrating efficacy and safety in clinically relevant models.
Modern infectious disease research includes small molecules, antibodies, vaccines, peptides, oligonucleotides, mRNA therapeutics, viral vector-based therapies, and other emerging treatment approaches. The most appropriate modality depends on the pathogen, disease biology, and therapeutic strategy.
Antimicrobial resistance occurs when microorganisms evolve mechanisms that reduce or eliminate the effectiveness of antimicrobial drugs. AMR is considered one of the most significant global public health challenges and is driving the need for new therapies and innovative treatment strategies.
Preclinical evaluation typically combines in vitro assays, disease-relevant animal models, microbiology and virology studies, pharmacokinetic and pharmacodynamic analyses, biomarkers, and safety assessments to establish efficacy, mechanism of action, resistance, and translational potential.
Pharmacokinetic/pharmacodynamic (PK/PD) studies evaluate the relationship between drug exposure and antimicrobial activity. These analyses help optimize dosing strategies, predict therapeutic efficacy, and support candidate selection before clinical development.
Clinical isolates are bacteria, viruses, or fungi obtained from infected patients. Evaluating drug candidates against clinical isolates helps determine whether therapies remain active against pathogens encountered in real-world clinical settings, including resistant strains.
Biomarkers provide measurable indicators of infection, immune response, target engagement, and treatment effect. They help researchers understand disease mechanisms, monitor therapeutic responses, and improve translation from preclinical studies to clinical development.
Successful infectious disease programs often combine discovery biology, disease pharmacology, DMPK, bioanalysis, and safety assessment to generate the efficacy, exposure, biomarker, and safety data needed to advance drug candidates.