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Stability Studies

Stability Testing

How Are You Managing Your Stability Studies?

Biological products can be sensitive to environmental factors.  Temperature, humidity, and light can impact a product’s attributes that might be critical to maintaining its quality, safety, and efficacy.

Regulatory agencies require sponsors to evaluate the impact of various environmental conditions on a product’s critical quality attributes. This evaluation is essential for determining the product's shelf life and ensuring that its attributes remain stable throughout the intended storage period.

Our GMP compliant testing services can assist you with the development and execution of long-term, short-term, and accelerated stability studies per ICH Q5C guidelines at all stages of your development process.

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Why Work with Us?

4500+

Stability samples currently stored

400+

Timepoints pulled last 12 months

230+

Active protocols

Partner with us for reliable stability testing

We deliver comprehensive GMP-compliant testing services for stability programs to ensure that your stability program meets the unique needs of your therapy.

Woman working in a lab on stability testing studies.

Partner with us to:

  • Unlock the full potential of your stability-indicating methods by harnessing the expertise of our highly skilled scientists, ensuring seamless development, transfer, validation, and execution for optimal product integrity.
  • Count on our expert regulatory and technical guidance to help you select the ideal testing packages, ensuring compliance and excellence at every step of your journey.
  • Tap into our comprehensive capabilities to unlock tailored solutions that perfectly align with your unique needs.
  • Leverage our expertise to design robust stability program protocols in accordance with ICH Q5C and ICH Q1 guidance and receive recommendations for key Critical Quality Attributes for stability testing that align with ICH Q6B expectations.

Tailor a stability protocol for your needs

Proven expertise

  • Technical and regulatory expertise to support the design and execution of your stability program
  • Streamlined process and clear workflow from proposal to report to ensure fast turnaround
  • Structured templates for stability protocols to define materials, time intervals, storage conditions, and testing methods

Tailored programs for your molecule

  • Benefit from our extensive experience with a wide range of biologics, including mAbs, ADCs, vaccines, cell therapies, gene therapies, mRNA/LNP, and other innovative modalities
A 3D illustration of a monoclonal antibody.
A 3D illustration of an ADC
A 3D illustration of a viral vector.
A 3D illustration of an mRNA/LNP
  • Take advantage of our accelerated testing conditions, designed to meet all regulatory requirements and ensure the integrity of your product
  • Offering a variety of storage conditions tailored to your product's requirements

Connect with an Expert

Thank you for your interest. Tell us about your project and we’ll connect you with one of our experts.

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