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cGMP biological assays

LGC biological assays

Biological assays to support biopharmaceutical development


LGC has developed and validated a range of bioassays which can provide support for biopharmaceutical development including:
 
  • Product characterisation
  • Stability assessment
  • Clinical trial material and product batch release testing
  • Neutralising antibody activity as part of immunogenicity screening. 

Bioassays are developed, validated and performed to the relevant regulatory guidelines of cGMP, GLP and GCP. We have state of the art instrumentation in our dedicated biopharmaceutics laboratories offering pharmacokinetic, immunogenicity and biological product assessment: 
 
  • Cell-based assays
  • Electrochemiluminescence
  • Luminescence
  • Absorbance
  • Time-resolved fluorescence.

Immunogenicity - anti-drug antibody screening and neutralisation assays
 
We have contributed to a wide variety of biopharmaceutical, working at the cutting edge of anti-drug antibody and neutralising antibody screening. Our experience includes:
 
  • Monoclonal Antibodies (mAbs)
  • Antibody fragments 
  • Antibody Drug Conjugates (ADCs)
  • Proteins
  • Peptides
  • Bispecifics
  • Biosimilars. 

We will choose the most appropriate analytical tools for your specific company and assay from our extensive range of techniques and platforms.

For further information on how LGC can assist with biological assay development, please contact us