Protein Formulation and Process Development along with GMP Fill Finish Services from a Single Experienced Source

Stability Programs

When conducted efficiently, stability testing can save time and money in the product lifecycle. Integrity Bio offers full service drug substance and drug product stability testing to support your expiry, management decisions, and regulatory submissions. Our veteran staff understands integrated global strategies to design and implement compliant and cost-effective stability programs. We nurture a strategic partnership to maximize communication and stability testing program reliability.

Regulatory Compliance

  • Ensure compliance to ICH guidelines and CFRs
  • Timely and accurate evaluation of product stability

Stability Chambers

  • State-of-the-art validated chambers
  • Full range of stability recommended and accelerated storage conditions
  • 24-hour monitored facilities with overlapping back-up systems
  • Dedicated responsive staff to address alarms and temperature excursions

Stability Testing

  • Reliable stability indicating test methods with cGMP testing capabilities
  • Scientifically sound and timely method transfers
  • Full QC analytical development and qualification/validation

Stability Study Management

  • Tailored stability protocol design and sample coordination
  • In-house stability testing, sample storage, and data trending
  • High-quality and timely technical reports and data summaries
  • Timely notification of OOT and OOS results