Overview
Custom Biologics provides comprehensive bioanalytical testing for biologics, vaccines, gene therapies, and biosimilars. Our assays support preclinical and clinical development, helping researchers measure potency, mechanism of action, and therapeutic activity with precision.

Why Choose Our Biologics Assays?

• Specialized Expertise: Experienced team in biologics characterization and bioanalytical assay development.

• Regulatory-Ready: Assays designed to meet GLP and GMP standards.

• Tailored Solutions: Custom assay development to match your product and study needs.

• Rapid Execution: Streamlined workflow to accelerate study timelines.

Applications

• Potency and mechanism of action testing for biologic drugs

• Pharmacokinetic and toxicokinetic studies in multiple matrices

• Immunogenicity testing (anti-drug antibodies, neutralizing antibodies)

• Biosimilar comparability and characterization

Our Process

1. Study Planning: Collaborate to design assay strategies for your biologic product.

2. Experimentation: Conduct bioanalytical assays in our specialized laboratory.

3. Data Reporting: Deliver comprehensive reports with assay results and interpretation.

4. Client Support: Maintain ongoing communication to guide decision-making.

Get Started
Accelerate your biologics development with Custom Biologics’ precise and regulatory-ready bioanalytical assays. Contact us to begin.