Prolytix provides bioanalytical services for coagulation and hematology, as well as for plasma-based protein therapeutics, 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.
Evaluation of Hemostatic Risk
This process involves a comprehensive assessment of the balance between bleeding and clotting tendencies. By integrating results from various analytical assays, clinicians can predict bleeding risk, tailor treatments, and optimize patient outcomes.
Learn more about the analytical tests for Hemostatic Risk
Hemophilia A / B
These X-linked bleeding disorders result from deficiencies in Factor VIII (Hemophilia A) or Factor IX (Hemophilia B). They are characterized by prolonged bleeding, particularly into joints and muscles, and require targeted replacement or non-factor therapies based on severity.
Learn more about the analytical tests for Hemophilia A/B
Hemophilia C (Factor XI Deficiency)
Hemophilia C is caused by a deficiency of Factor XI and is generally associated with a milder bleeding phenotype. Its variable clinical presentation necessitates a nuanced evaluation using both conventional and global coagulation assays to guide management.
Learn more about the analytical tests for Hemophilia C
von Willebrand Disease
The most common inherited bleeding disorder, von Willebrand Disease, stems from either quantitative or qualitative defects in von Willebrand factor. This affects both platelet adhesion and Factor VIII stabilization, making a detailed laboratory workup crucial for proper classification and treatment.
Learn more about the analytical tests for von Willebrand Disease
Direct Oral Anticoagulants (DOACs)
DOACs provide predictable anticoagulation by targeting specific coagulation factors (either Factor Xa or thrombin). While they simplify anticoagulant therapy, specialized assays are sometimes needed to assess drug activity in situations such as bleeding, urgent surgery, or renal dysfunction.
Learn more about the analytical tests for DOACs
Biomarker Testing
- Custom assay development and validation
- Commercial kit qualification/validation
- Transfer sponsor-specific proprietary assays for qualification of validation
- Understanding of regulatory expectations for biomarker analytical validations based on the context of use to provide custom assay development and/or validation
- Biomarker testing technologies:
- Meso Scale Discovery-Electrochemiluminescence (MSD-ECL)
- ELISA
- HPLC
- Off-the-shelf coagulation assays
- Hemostatic risk assessment
- Platelet aggregation studies
- Thrombin generation assays (TGAs) and thromboelastograph (TEG)
- Quantitative Western Blot
Plasma-Based Proteins Bioanalytical Services
Whether you want to understand plasma proteins better or smooth the transition from the lab to the clinic, or you’re developing a novel plasma protein therapy, Prolytix has the protein chemistry expertise to deliver high-quality results quickly.
Prolytix performs isolation and characterization of quality plasma proteins for in vitro research use. Our scientists have extensive proteomics experience and are here to help you solve your early-phase large-molecule drug development challenges.
Explore our Plasma Protein Bioanalytical Services
- Host Cell Protein Analysis
- Method Development
- Process Development
- GMP Stability Testing & Storage
- GMP Release Testing
High-Resolution Mass Spectrometry Services
- Peptide Mapping
- N-Glycan Analysis
- Sequence Variance Analysis
- Proteomic Analysis
Multiomics and LC-MS/MS solutions powered by strategic partner, Allumiqs