Anti-drug antibodies (ADAs) can hinder development of complex therapeutic modalities, like bispecific molecules and gene therapies. It is critical to understand the potential for ADA formation by the host of these therapeutic drug products as well as the impact of ADA on critical in vivo parameters such as PK and drug clearance rate. Having a robust […]
Anti-drug Antibody (ADA) Assays for Complex Molecule Development Read More »
In today’s fast-evolving biotech landscape, artificial intelligence (AI) is not just a tool—it’s a catalyst for revolutionary change. AI-driven companies are using advanced algorithms to predict molecular behavior, identify novel drug targets, and streamline clinical decision-making. However, even the most sophisticated in silico models require one essential element to reach their full potential: robust, high-quality
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.
AI Drug Discovery to Lab Breakthroughs: Turning Models into Reality | Fact Sheet Read More »
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.
Coagulation & Hematology Assays for Biologic Therapies | Fact Sheet Read More »
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.
Biomarker Assay Development and Analysis Services | Fact Sheet Read More »
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.
Biosimilar Development Support: Testing & Characterization | Fact Sheet Read More »
In the world of complex research projects, achieving a balance between scientific rigor and operational efficiency is no small feat. At the heart of this challenge lies our PMO’s commitment to three guiding principles: clear prioritization, structured flexibility, and stakeholder alignment. 1. Clear Prioritization We collaborate closely with scientific teams to identify critical project milestones
How PMOs Balance Scientific Rigor and Operational Efficiency Read More »
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.
Immunogenicity Testing and ADA Assay Services | Fact Sheet Read More »
