Comprehensive biopharmaceutical product analysis and potency laboratory services addressing the challenges of identity, purity, safety and quality for proteins, monoclonal antibodies (mAb), vaccines, oligonucleotides and biosimilars.
Biopharmaceuticals (such as recombinant proteins, monoclonal antibodies, vaccines, peptides, oligonucleotides, biosimilars) can present unique analytical challenges during their development and manufacture. Their structural characteristics must be well understood to ensure product's quality and identity. Any process or product related impurities must be identified and quantified and biophysical properties and biosafety must all be explored to ensure a safe biologic medicine.
Intertek provides extensive GLP and cGMP biopharmaceutical services for biologics from early stage through to GMP manufacture and beyond. With over 20 years experience in the analysis of protein products or oligonucleotides Intertek's comprehensive services have been developed with the relevant regulatory guidance in mind. For protein products in particular, services in line with the requirements of ICH Q6B guidelines including structural characterization, physico-chemical property analysis, impurity profiling and cell based bioassays offer a one-source solution for our clients, supporting their product development from early stage through to manufacturing. Intertek has expertise in advanced and comprehensive characterization studies, method development and validation (employing a diverse range of specialized techniques), stability studies, QC testing, GMP batch release analysis and more.
Protein Analysis Services (ICH Q6B)
Vaccine Analysis Services
Oligomedicine Analysis Services