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Stability Testing Services

Stability Testing

Biologics stability programs to meet regulatory requirements

Biological products and therapies have specific physiochemical and biological attributes that can be particularly sensitive to environmental factors. Attributes critical to a product’s quality may change with time and under specific conditions. Therefore, regulatory agencies require that these critical quality attributes be tested to determine a product’s shelf life and to confirm that a product remains stable throughout its intended storage period. Our GMP-compliant testing services can assist clients with the development and execution of long-term, short-term, and accelerated stability studies per ICH Q5C guidelines at all stages of the development process.

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Our Track Record

4500+

Stability samples currently stored

400+

Time points pulled last 12 months

230+

Active stability protocols

Partner with us to de-risk your stability testing

We deliver comprehensive GMP-compliant testing services for individual time points, as well as regulatory and technical expertise to ensure that your stability program meets the unique needs of your therapy. Partner with us to:

  • Benefit from the extensive experience of our highly skilled scientists to ensure robustness of your stability-indicating methods
  • Rely on our regulatory and technical guidance on the choice of testing packages
  • Leverage our global network and comprehensive capabilities to streamline operations

We follow the ICH Q5C guidance to design stability programs and can recommend commonly used Critical Quality Attributes for stability testing according to ICH Q6B expectations:

  • Compendial (pH, osmolality, concentration)
  • Identification (intact mass, amino acid analysis, glycan profiling, sequence mapping)
  • Impurity testing (size variants, charge variants)
  • Potency/binding (Fc gamma receptor, C1q binding assay, cell-based assays)
  • Biosafety (bioburden, endotoxin, sterility)
  • Process residuals (detergents, surfactants, residual proteins, and DNA)

Tailor a stability program for your needs

Proven expertise

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

Tailored programs for your molecule

  • Experience with various types of biologics including mAbs, ADCs, vaccines, cell therapies, gene therapies, mRNA/LNP, and other novel modalities
  • Global footprint with a variety of storage conditions
  • Special conditions allowed such as accelerated and stress tests to meet your specific needs

Supporting Technical Content

Taking Charge of Your Stability Program - White Paper

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

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