Prolytix leverages 35+ years of protein chemistry experience to support the large-molecule drug product lifecycle from discovery through release. As your bioanalytical testing partner, Prolytix leverages our vast protein chemistry expertise, skilled project management team, and agile, consultative approach to deliver an average of 100% on-time delivery and high-quality data to streamline decision-making.
Our capabilities and team’s expertise include:
- Recombinant Proteins, Monoclonal Antibodies (mAbs), Bispecifics
- Coagulation & Hematology
- Food Allergens
Whether you need analytical characterization to support chemistry, manufacturing, and control (CMC) or method development and validation to support clinical and drug release testing, discover how Prolytix can accelerate and de-risk your drug development program.
Explore Our Bioanalytical Services
R&D Services
Prolytix’s GLP, GCLP, and CLIA facilities, plus 35+ years of experience developing and conducting critical bioanalytical testing services, will swiftly and safely advance your large molecule drug product to market.
Large Molecule Characterization Services
Prolytix is a bioanalytical CRO with extensive experience characterizing critical aspects of large molecule therapeutics, providing high-quality data to expedite development decision-making.
GMP Release & Stability Testing
Our team supports your drug product’s journey through discovery, clinical trials, regulatory approval, and commercialization with testing performed at our GMP-compliant facilities.
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Host Cell Protein Analysis
Ensure the safety and efficacy of your drug product with a full suite of Host Cell Protein (HCP) analysis and protein characterization using high-resolution mass spectrometry (HRMS).
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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