Prolytix

About Prolytix

Prolytix performs GMP release testing for both commercial and clinical trial drug substances and drug products. We test bulk, final product, and in-process materials in our fully compliant, FDA-inspected facility. Combined with our other Chemistry, Manufacturing, and Control (CMC), Excipient and drug development services, you’re assured the highest quality from early-phase clinical development through commercial release. 

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Certifications
  • CE
    CE
  • FDA
    FDA
  • GMP
    GMP
  • ISO
    ISO
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Sales Markets
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Categories
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  • US
  • 2022
    On CPHI since
  • 4
    Certificates
  • 25 - 49
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Primary activities
Analytical Services
Laboratory Services
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Contact info
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Meet us at

CPHI Americas 2025

Pennsylvania Convention Center, Philadelphia
20 May 2025 - 22 May 2025
View Exhibitor Profile

Prolytix Resources (1)

  • Improvements to PS80 Detection in Drug Product Formulations

    Whitepaper Improvements to PS80 Detection in Drug Product Formulations

    A Mixed-Mode High-Performance Liquid Chromatography Method for the Determination of Polysorbates Offers Notable Improvements Over a Conventional Reverse Phase HPLC Method. We are presenting an innovative enhancement to the conventional reverse phase (RP) High Performance Liquid Chromatography (HPLC) method utilized for the analysis of polysorbates, including Polysorbate 80 (PS80).The new and improved approach to polysorbate analysis involves mixed-mode HPLC. Mixed-mode HPLC offers several advantages over the RP method, including reduced run times, improved signal resolution, minimal sample preparation, and decreased reliance on consumables. These enhancements not only improve data analysis, but also lead to substantial cost savings compared to the RP method, while also reducing the potential errors associated with extensive sample handling.