Stability studies of small molecules and proteins

Ensuring Efficacy of Your Active Compounds

In the rapidly evolving fields of biotechnology and pharmaceuticals, ensuring the stability of active compounds—whether small molecules or proteins—is crucial for the success of your products. Stability studies are essential to understand how these compounds behave under various environmental conditions over time. At GlycoMScan, we offer comprehensive stability studies designed to meet the needs of biotech companies, startups, and pharmaceutical firms.

Why Stability Studies Matter

  • Quality Assurance: Stability studies help identify potential degradation products and their impact on the safety and efficacy of your compounds, maintaining high-quality standards. One analysis that we offer these days is the quantification and release rate of payload from antibody-drug-conjugates (ADCs).
  • Regulatory Compliance: Regulatory agencies require extensive stability data to approve new drugs and therapies. Ensuring your compounds meet these stringent requirements is essential for market entry.
  • Shelf Life Determination: Understanding the stability of your compounds helps in determining their shelf life, ensuring they remain effective and safe for use throughout their intended duration.
  • Formulation Development: Stability data are essential for developing robust formulations that can withstand various storage and transportation conditions.

Stability Study Services:

  • Expertise in Small Molecules and Protein
  • Payload release from antibody-drug conjugates
  • Long-term Stability Studies: Assess the stability of your compounds over extended periods to understand their shelf life and long-term efficacy.
  • Accelerated Stability Studies: Expedite the stability testing process by subjecting your compounds to elevated stress conditions, providing quicker insights into their behaviour.
  • Real-time Stability Studies: Monitor the stability of your compounds under real-world storage conditions to gather realistic and applicable data.
  • Stress Testing: Evaluate the stability of your compounds under extreme conditions (temperature, humidity, light) to identify potential degradation pathways.

Our Methodology:

  • Initial Assessment: Comprehensive evaluation of your compounds' properties and stability requirements.
  • Study Design: Tailored stability study protocols designed to meet regulatory guidelines and specific project needs.
  • Sample Storage: Controlled storage conditions that mimic real-world and stress scenarios.
  • Regular Monitoring: Periodic sampling and analysis to track the stability of your compounds over time. 
  • Detailed Reporting: Comprehensive reports that include data interpretation, degradation analysis, and stability projections.