Custom Bioanalytical Method Development Services
Tap into our deep protein chemistry expertise for compliant bioanalytical method development and validation that will help advance your drug product. Prolytix’s bioanalytical method development services provide relevant, timely data for rapid tech transfer and are supported by 35+ years of experience with large molecule drugs and protein analysis. Our team offers method development services for assays, including:
- Pharmacokinetics Assays
- Immunogenicity Assays
- Biomarker Assays
- Characterization
- Protein Identification & Quantification
- Host Cell Protein (HCP)
Our R&D services support preclinical, clinical, and CMC studies to help ensure that your protein-based or other large-molecule biotherapeutic reaches commercialization quickly and efficiently.
Techniques and Methods Utilized
Protein-Based Therapeutics
- Aggregation State
- Biomarker Assay Development and Validation
- Host Cell Protein Solutions
- Enzyme Kinetics/Functional Assays
- Liquid Chromatography (HPLC/FPLC)
- Ligand-Binding Assays (LBAs)
- Antibody Conjugation
- Critical Reagent Manufacture
- Quantitative Western Blot
- SDS-PAGE/Capillary Electrophoresis (CE)
- Charge Variant Analysis (cIEF)
- Process Development
- Protein Purification
- Preclinical Sample Analysis
Immunogenicity
- Anti-Drug Antibody (ADA) Assays
- Screening Assays
- Neutralizing Antibody Assays
- Confirmatory Assays
Hematology & Coagulation
- Clotting and Chromogenic Substrate Assays
- Hemostatic Risk Assessment
- Plasma Fractionation
- Platelet Aggregation
- Thrombin Generation Assays (TGA)
- Thromboelastography (TEG)
Why Is Analytical Method Development and Validation So Important?
Analytical method development evaluates to ensure an assay is effectively constructed to determine a drug’s composition. This process ensures that the method is suitable for measuring samples’ concentration and establishing the drug’s identity, purity, physical characteristics, potency, and safety.
To qualify an analytical method, Prolytix scientists compare specific samples of the compound to a standard to establish reproducibility, ensuring the method is suitable for its intended purpose.
Analytical method validation is crucial. The FDA and other leading regulatory bodies only accept fully validated methods, and the company must prove that its methods meet FDA guidance. Validation confirms that a protocol ensures robust, valid results regardless of the sample quality.
Analytical method development and validation are critical aspects of drug development and manufacturing. Whether you need methods developed or validated, Prolytix can help.