Pharmaceutical Stability Analysis

Drug-resistant cell model generation service

The stability of proteins is a critical factor in their manufacture, storage and use. Creative BioMart provides a complete range of ICH stability conditions and cGMP test methods to assure the accurate profile of your biopharmaceutical product during all stages of drug development, from early research & development to commercial or post approval studies. Our stability testing service provides essential data on how the quality of a pharmaceutical varies over time under the influence of different environmental factors such as temperature, humidity, photostability, cycling and freeze/thaw. Custom storage conditions are available to support your specific procedures and timelines—whether you require storage only, temperature, humidity, photostability, cycling and freeze/thaw and testing, testing only, and/or project management assistance. Plus, stability reports can be tailored to meet your needs.

Creative BioMart is integrated within the laboratory testing complex and provides following services:

Service Items:

  • All temperature and humidity conditions needed to comply with ICH guidelines
      • 75% relative humidity/40°C
      • 60% relative humidity/25°C
      • Ambient humidity/25°C, 30°C, 40°C, 50°C, 55°C
      • Refrigeration at 5°C
      • Freezer at -20°C and -80°C
      • Liquid nitrogen
  • A Alternate custom conditions can also be created;
  • Forced degradation study;
  • Freeze/thaw study;
  • Photostability study;
  • Mechanical stress;
  • Container compatibility;
  • In-use studies (IV bags, infusion pumps, etc.);
  • Drug-substance stability testing;
  • Accelerated stability;
  • Long-term stability.

Stability Analysis Techniques:

  • Gel Electrophoresis;
  • Western blot;
  • ELISA/Immunoassays;
  • Isoelectric focusing;
  • Capillary electrophoresis;
  • Amino-acid analysis;
  • Chromatography and Mass Spectrometry;
  • Immunochemistry techniques;
  • Dynamic light scattering (DLS);
  • Far- and near-UV circular dichroism spectroscopy;
  • Fluorescence spectroscopy;
  • Differential scanning calorimetry (DSC);
Pharmaceutical Stability Analysis

Our pharmaceutical testing applies specialized knowledge to increase your competitive advantage. Creative BioMart's pharmaceutical stability testing services supply numerous benefits:

  • Receive quicker regulatory approvals;
  • Get high-quality testing customized to your requirements;
  • Save costs;
  • Reduce or eliminate risks;
  • Get rapid, reliable turnarounds;

Request more information to see how Creative BioMart can help you with Pharmaceutical Stability Analysis.

Welcome to contact us or send an email to info@creative-biomart.com for project quotations and more detailed information.

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