Analytical Services for mAb, ADC, and Protein Drugs
Analytical and bioanalytical methods are crucial in the development of monoclonal antibodies (mAb), antibody-drug conjugates (ADC), and other protein drugs. From early-stage discovery and preclinical testing to clinical trials and CMC (Chemistry, Manufacturing, and Controls) support, robust analytical methodologies ensure the safety, efficacy, and quality of therapeutics. Their role is indispensable in advancing innovative therapies and bringing life-saving treatments to patients.
Analytical Services for mAb, ADC, and Protein Drugs
Our Expertise
We are dedicated to accelerating your biologic drug development process and ensuring the safety, efficacy, and quality of your therapeutic candidates. Our expertise spans genomics, proteomics, microbial analysis, and immunoassays, supporting a wide range of biologics, including monoclonal antibodies (mAbs), Antibody-drug conjugates, protein drugs, and other therapeutic proteins. Explore our detailed service offerings below, categorized into preclinical studies, clinical studies, and Chemistry, Manufacturing, and Controls (CMC)
Analytical Support Through All Stages of Product Lifecycle
Phase
Technologies
Applications
Development
- Clone selection/screening
- Genetic stability testing
- Growth kinetics analysis
- mAb /Protein Expression and Characterization
Preclinical Studies
- Immunogenicity studies
- Biomarker analysis
- In vitro efficacy studies
- Cytokine release assays
Clinical Studies
- Clinical PK/PD studies
- Patient stratification
- Immunogenicity testing
- Biomarker validation
- Companion diagnostics development
- Cytokine release assays
CMC Support
Regulatory Guidance
This draft guidance provides recommendations for developing assays to evaluate potency as part of a potency assurance strategy for active immunotherapy products (ACTIMPs), including peptide- and protein-based ACTIMPs that are not cellular or gene therapy products. It supplements FDA's December 2023 draft guidance "Potency Assurance for Cellular and Gene Therapy...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.” The draft guidance provides recommendations for streamlined approaches to assess long-term safety from monoclonal antibodies that recognize a single molecular target (referred to as monospecific...
This guidance describes the Agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under section 351(a) of the Public Health Service Act (PHS Act). Additionally, this guidance is intended to...
