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
CRO With 100% On-Time Delivery
100% On-Time Delivery. Is This True?
No CRO can guarantee to be 100% on-time 100% of the time, but last year, Prolytix averaged 100% on-time delivery. We’ll share the processes and track record that make this possible.
White Paper: Improvements to PS80 Detection in Drug Product Formulations
This technical white paper describes the mixed-mode HPLC method Prolytix developed to notably improve the determination of polysorbates, such as PS80, in drug product formulations.
Prolytix stands out as a service provider of choice due to an impressive depth of blood and protein knowledge and a higher touch service model versus larger players.
Senior program manager, biotech company focused on immune deficiency disorders
The scientific knowledge and rigor Prolytix brought to the table was excellent, and turnaround time was fantastic compared to the large, global CROs. Prolytix clearly understood the scope of our request, their written reports were clear and exceeded our expectations for GMP scientific reports.
CEO, biotech company focused on development of immuno-oncology and infectious diseases therapeutics
The Prolytix team was timely, precise, concise, and helpful in developing the best immunoassay for our needs. We successfully improved upon the published finding and also gained certainty about species specificity. It is essential to have good assays to clearly understand biology. I am very grateful to have had the opportunity to work with this team and hope to work with you again in the near future.
Director, Immunology & Biomarkers, midsized biotech company