Bridge the gap between in silico predictions and real-world lab results. Prolytix empowers AI-driven biotech companies with rapid, GMP-compliant bioanalytical testing, scalable manufacturing support, and expert regulatory guidance. From high-throughput screening to assay validation and PK/PD studies, we deliver the data and quality you need to refine models, accelerate timelines, and increase clinical success rates.

From hemophilia diagnostics to evaluating off-target coagulation effects, Prolytix delivers a full suite of coagulation and hematology testing solutions. Our expertise spans TEG, TGA, factor assays, platelet aggregation, von Willebrand factor analysis, DOAC testing, and more—backed by custom assay development, proprietary controls, and innovative method creation to meet unique program needs.

Prolytix provides expert biomarker assay services for bioanalytical and GMP testing, supporting discovery, validation, and monitoring for preclinical and clinical studies. Utilizing advanced platforms, we deliver fit-for-purpose methods, high-quality data, and regulatory-compliant solutions, accelerating drug development and empowering informed decisions for your therapeutic innovations.

The analytical assay requirements for a biosimilar are crucial to demonstrate its similarity to the reference biologic. These assays are designed to assess the physicochemical, biological, and functional characteristics of the biosimilar to ensure that it matches the reference product in terms of quality, safety, and efficacy.

Ensure the safety and efficacy of your protein therapeutics with custom ADA assays built for high sensitivity, reliability, and regulatory compliance. From monoclonal antibodies to gene therapies, our GLP, FDA- and MHRA-inspected facility delivers the expertise you need—anywhere in the world.

Trust Prolytix to provide data that are not only accurate but also optimally resolved, driving greater confidence in your excipient analysis results. Download our resource to learn more.

Developing novel biotherapeutics that are safe and effective requires a strategic and collaborative approach. At Prolytix, we offer integrated bioanalytical services that span your product’s entire life cycle, providing you with critical insights for confident decisions. Download our fact sheet to learn more.

Choosing the appropriate analytical and bioanalytical CRO partner is critical to the success of your biotherapeutic drug development program. Selecting the wrong partner could delay timelines and increase costs, putting your innovation at risk. For large molecule and protein chemistry expertise to accelerate your drug development, go with the pro — Prolytix. Download Now: