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Analytical Development

We use our insight and experience to inform a tailored approach to your biologics' analytical requirements.

We deliver a comprehensive range of in-house analytical services to ensure your biologic product meets specification requirements throughout its lifecycle.

Meeting your timeline and budget requirements, our labs are equipped with state-of-the-art instrumentation which our experts leverage to provide development and validation services tailored to your in-process and release testing needs.

Our scientists offer deep expertise in method development, data acquisition, analysis and interpretation of complex biopharmaceuticals in line with the most demanding global regulatory standards. We support the testing of your biopharmaceutical molecules from a GLP and CGMP research facility, ensuring you get reliable results.

 

 

In-Process Analytics

  • HPLC/UPLC based methods
  • Process related impurity (HCP, HcDNA) analysis
  • Clone analysis through gel electrophoresis, western blot,
    biolayer interferometry, RTPCR

 

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Method Development

  • RP, NP, HILIC, IEX and SEC methods
  • Transfer, validation and verification

 

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Product Characterization

  • Glycan profiling
  • Structural characterization
  • Thermal analysis
  • Intact mass analysis
  • Peptide mass fingerprinting
  • Sequence confirmation
  • Disulfide bond confirmation
  • Identification of post translational modifications (PTMs)
  • Process/product related modifications or impurities
  • Determining secondary and tertiary protein structure

 

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Stability Analysis

  • Extractables and Leachables (E&L) studies
  • Photostability
  • Forced degradation
  • Impurity purification and characterization

 

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