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Stability Characterization

Stability Testing Programs

Stability studies during biosimilar development are critical along a candidate's road to becoming a commercial drug. Based on the ICH Q5C guidance, the stability analysis tests the potency, purity, molecular characterization, and product characteristics of a biosimilar candidate under various environmental conditions over a specific timeframe. Many factors can affect the stability of biologics and biosimilars, therefore, there is complex analytical methodologies to profile the stability characteristics. A range of studies must be designed to provide assurance of the stability of the product.

Creative Biolabs' Expertise to Progress the Biosimilar Development Efforts

Creative Biolabs is a leader in the antibody development and manufacturing of recombinant antibody products. We have completed thousands of custom antibody expression projects and we will utilize our experience to support biosimilar studies. Our team has extensive experience and expertise in monoclonal antibody analysis including physicochemical, biological activity, stability assays. Our know-how and long standing expertise in antibody development process enables us the leading partner for your biosimilar development project. We formulate a detailed biosimilar stability study plan to provide assurance of the potency and biological activity of biosimilars, optimization of formulation, and determination of the shelf life. Our staff can support stability studies from start to finish and help prevent problems that might arise otherwise. We carry out routine stability analysis, as well as complex analytical testing, including:

  • Long-term drug stability study
  • Accelerated stability study
  • Stress stability study
  • Photo-stability study
  • Real-time real-temperature stability study, temperature cycling, freeze-thaw study
  • Forced degradation testing
  • Mechanical stress
  • Shelf life assessments
  • Shipping study
  • In-use study
  • Stability of diluent(s)
  • Tailored Stability Study

Stability Testing Methods

At Creative Biolabs, we have the tools and experience needed to rigorously characterize stability of biosimilars. We evaluate biosimilar and therapeutic protein stability using state-of-the-art analytical facilities and techniques including:

  • Western blot
  • Capillary electrophoresis (CE)
  • Peptide mapping and sequencing by LC-MS/MS
  • Analytical ultracentrifugation (AUC)
  • Dynamic light scattering (DLS)
  • Circular dichroism (CD)
  • Differential scanning calorimetry (DSC)
  • Nuclear magnetic resonance (NMR)
  • Infra-red spectroscopy (FTIR)
  • cGMP cell-based bioassays
  • Aggregation analysis
  • Glycan profiling
  • Immunochemistry techniques
  • Spectroscopic profiles

Find Out More Stages in Biosimilar Development:

The process of a Biosimilar development.Fig.1 The process of a Biosimilar development. (Creative Biolabs)


Creative Biolabs is a company focused on the development of antibody products. We have expereince in manufacturing a series of recombinant biosimilar antibodies. Our biopharmaceutical scientists have the extensive knowledge, expertise, and capabilities that navigate the challenges of biosimilar development, clinical use, and approval process. We are experienced in process development, manufacturing, regulatory and provide industry-leading bioanalytical support. We deliver insight to our customer and deploy a range of tests to bring a biosimilar to market. We are seeking partnerships with companies who are interested in co-developing biosimilars. It will be our pleasure to share your ideas with us.

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More About Biosimilar


  1. Demirhan, D. Stability evaluation of the biosimilar monoclonal antibody using analytical techniques. Turkish Journal of Pharmaceutical Sciences. 2023, 20(1): 48.

For research use only. Not intended for any clinical use.

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