Prolytix provides bioanalytical services for large-molecule developers of recombinant proteins, monoclonal antibodies (mAbs), bispecifics, and other proteins from late discovery through release. With more than 35 years of expertise and integrated GLP, GCLP, CLIA, and GMP facilities, our transparent communications, close client collaboration, and dedication to high-quality data support decision-making and expedite regulatory filings. All our bioanalytical testing facilities maintain an outstanding FDA and client inspection track record.
Monoclonal Antibodies (mAbs) and Polyclonal Antibodies (pAbs) Bioanalytical Services
As precision medicine advances, researchers continue to discover new ways to use monoclonal antibodies (mAb) and polyclonal antibodies (pAb) to treat immunologic conditions, cancer, and other diseases.
With extensive protein chemistry expertise, a consultative and multidisciplinary approach, and efficient turnaround times, Prolytix provides analytical services to support mAb and pAb drug development.
Learn more about our Analytical Methods for Antibodies
Bi and Tri-Specific Bioanalytical Services
Bi and Tri-specifics offer a promising avenue for addressing a myriad of health challenges, including cancer, chronic inflammatory, autoimmune and neurodegenerative diseases, and other conditions.Â
Prolytix protein chemists have developed a reputation for excellence, backed by 35 years of legacy expertise in protein analysis services. We offer a comprehensive range of exceptional-quality bioanalytical services to support bispecific drug development.
Learn more about our Analytical Methods for Bi and Tri-Specific Proteins
Recombinant Protein Bioanalytical Services
Recombinant protein analysis requires a multistep approach. Prolytix has the protein chemistry expertise to design a valuable, cost-effective approach to help determine the potency and purity of recombinant proteins.
Using phase-appropriate techniques, Prolytix provides a wide range of analytical and bioanalytical services for recombinant protein therapies, from method and process development to GMP release testing and GMP stability testing.
Learn more about our Analytical Methods for Antibodies
Enzyme Replacement Bioanalytical Services
Our advanced analytical platform is designed to support the development of enzyme replacement therapies. We provide a robust suite of assays to ensure your product meets the highest standards in pharmacokinetics, pharmacodynamics, immunogenicity, biomarker validation, and CMC bioanalytical testing, helping you demonstrate therapeutic equivalence and quality for patients with rare metabolic disorders and other enzyme deficiency conditions.
Learn more about our Analytical Methods for Enzyme Replacement
Biosimilar Bioanalytical Services
Our cutting-edge analytical platform is designed to support the development of biosimilars by demonstrating similarity to the reference product. With robust assays covering pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and CMC bioanalytical testing, we ensure that your biosimilar meets the highest standards of quality, safety, and efficacy.
Learn more about our Analytical Methods for Biosimilars
Explore our Bioanalytical Services
- Pharmacokinetics Assays
- Biomarker Assays
- Characterization
- Protein Identification & Quantification
- Host Cell Protein Analysis
- Method Development
- Process Development
- GMP Stability Testing & Storage
- GMP Release Testing
High-Resolution Mass Spectrometry Services
In addition to the wide range of techniques and methods used by Prolytix bioanalytical experts, we also offer comprehensive HRMS characterization services, including:
- Host Cell Protein (HCP) Analysis
- Peptide Mapping
- Post-Translational Modification
- N-Glycan Analysis
- Capsid Characterization
- Sequence Variance Analysis
- Proteomic Analysis
Multiomics and LC-MS/MS solutions powered by strategic partner, Allumiqs