Stability

Stability
Supporting Shelf-Life, Storage and Regulatory Confidence
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Stability testing is essential for establishing shelf-life, defining storage conditions and ensuring product integrity across preclinical, clinical and commercial programs. Minaris Advanced Testing offers comprehensive stability testing of biologics and advanced therapy products, aligned with ICH Q1 guidelines and global regulatory expectations.

Our services include long-term, real-time, ongoing and accelerated testing programs, enabling you to make informed decisions on product labeling, shipping and lifecycle strategy.

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ICH Q1-Compliant Stability Testing Services

Minaris Advanced Testing provides full protocol development and execution, tailoring every study to your product and regulatory strategy.

Long-Term Stability Studies

Simulate real-world storage over the intended shelf-life

Real-Time Stability Studies

Assess product behavior under standard storage conditions

Ongoing Stability Studies

Support post-approval monitoring and commercial compliance

Accelerated Stability Studies

Expedite time-to-data by simulating extended storage

Fit-for-Purpose Design Across Product Types

Our stability testing services support a wide range of modalities:

  • Autologous and allogeneic cell therapies
  • Viral vector gene therapies (AAV, LVV and other platforms)
  • Viral vaccines
  • Recombinant proteins and monoclonal antibodies
  • Gene-edited and stem cell products

Assay Integration and Method Support

All stability-indicating assays are developed, transferred, or qualified/validated under GMP. We offer:

  • Protocol and pull-point planning
  • Analytical sciences method qualification and validation
  • Individual time-point and comprehensive study reporting
  • Submission-ready documentation for global regulatory authorities
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Stability Testing Facilities and Infrastructure

Minaris Advanced Testing’s stability testing services are based in Philadelphia, PA, USA. Situated near our manufacturing and QC release testing labs, it performs testing for ATMPs and standard biologics across multiple modalities.

All facilities operate under robust quality systems with audit readiness for the FDA, EMA, PMDA, and other global regulatory agencies.

  • The testing facility located in Philadelphia is the cornerstone of Minaris’ testing network. At 140,000 square feet, it is one of the largest dedicated biosafety and analytical testing buildings in the industry. The campus integrates molecular biology, virology, microbiology and QC laboratories under one roof, enabling seamless coordination across testing disciplines. Expanded in 2021, our testing facility increased sample throughput by more than 130 percent, with significant gains in virology, microbiology and quality control. Today, the site supports over 1700+ developed assays.

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Whether you need GMP release testing for a commercial therapy or exploratory analysis for an early-phase asset, we’re here to help. Access our full testing catalogue or submit a sample request today.

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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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