Bioanalytical Testing Services

Prolytix supports large-molecule developers from late discovery through release. With more than 35 years of expertise and integrated GLP, GCLP, CLIA, and GMP facilities, our expertise, transparent communications, close client collaboration, and dedication to high-quality data support decision-making and expedite regulatory filings. All of our testing facilities maintain an outstanding FDA and client inspection track record.

Our capabilities and team’s expertise apply to:

• Recombinant Proteins, Monoclonal Antibodies (mAbs), Bispecifics
• Coagulation & Hematology
• Food Allergens

Bioanalytical Services

Conducted in GLP, GCLP, CLIA, and GMP facilities, our bioanalytical services support all phases of a therapeutic’s product lifecycle.

Pharmacokinetics (PK) 

• Determines drug exposure in the body over time using parameters to evaluate the absorption, distribution, metabolism, and excretion (ADME) of the drug
• Target analyte quantitation via:
  • ELISA
  • HPLC
• Electrochemiluminescence (ECL)
• In-vivo support available after sample collection
• Full support of in-vitro studies

Immunogenicity

• Multiple ADA screening assay formats with high reliability and sensitivity for the semi-quantitative or qualitative of potential antibodies. 
• Assay formats vary between proteins and likely depend on the therapeutic protein class. 
• Formats to detect antibodies with desired specificities (IgM, IgG subclasses, etc.)
• Direct/Indirect ELISA
• Bridging ELISA
• Electrochemiluminescence (ECL)

Biomarker Testing

• Custom assay development and validation
• Commercial kit qualification and validation
• Transfer sponsor-specific proprietary assays for qualification of validation
• Through understanding of regulatory expectations
• Coagulation assays
• Hemostatic risk assessment
• Platelet aggregation studies
• Thrombin generation assays (TGAs) and thromboelastograph (TEG)
• Quantitative western blot

Characterization Services

• Physicochemical properties
• Biological activity/potency
• Immunochemical properties
• Purity, impurities, and contaminants
• Quantity
• Protein ID and quantification
• Gel-band identification
• Post-translational modifications
  • Oxidation
  • Deamidation
  • Glycosylation
  • Disulfide mapping
  • Pegylation
  • Phosphorylation
• Aggregation
• Charge heterogeneity
• Host Cell Proteins
• PS20/PS80
• Relative Potency

GMP Release and Stability Testing Services

Release Testing

• Bulk, final product, and in-process materials 
• Validation studies on all tests and processes used to demonstrate product compliance
• Pre-defined GMP release testing protocol

Stability Testing

• Drug stability testing procedures for large molecule biopharmaceutical and proteinaceous IVD reagents
• Real-time and accelerated stability programs and shelf-life determination. 
• ICH-compliant storage under a wide range of temperature and humidity requirements

Bioanalytical Methods Utilized

Prolytix utilizes state-of-the-art bioanalytical methods to ensure the highest quality testing and data.

• Compendial 
• Excipients: pH modifiers, tonicity, amino acids, preservatives, chelators, surfactants, inhibitors
• Osmolality measurement
• Residual moisture determination
• HIAC liquid particle analysis
• Thrombin generating assays
• HPLC/UPLC methods (reverse phase, size exclusion, ion exchange)
• SDS-PAGE
• Clotting assays (factor assays, PT, aPTT, NAPTT)
• Anti-drug antibody assays
• Relative potency
• Protein concentration