Biopharmaceutical Development and QA/QC  

During process development and before entering clinical trials, the primary structure of a recombinant protein must be confirmed, and all potential post-translational modifications (PTM) must be characterized to assess the associated risk. Peptide mapping is the fundamental technique for this purpose, whereby the recombinant protein is enzymatically digested into peptide fragments that are chromatographically separated to give a fingerprint of the primary structure. When coupled to mass spectrometry, peptide mapping can also give precise identification of various PTMs.

Bioanalytical method development is the critical step in the biopharmaceutical pipeline as it bridges the transition to pre-clinical and clinical phases. Ligand-binding assay (LBA) has been the common technique for biologics, however, LC-MS is emerging as an alternative to reduce time and cost needed for method development and to gain increased selectivity and efficiency.

Data integrity compliance has become one of the most important components of the pharmaceutical industry’s responsibility to ensure the safety, efficiency and quality of drugs to protect human health. However, regulatory agencies have observed an increasing number of Current Good Manufacturing Practice (CGMP) violations related to data integrity in recent years. Regulatory agencies expect data to be reliable and accurate on the CGMP criteria for all laboratory instruments, including UV-Vis and FT-IR, as well as all other standalone instruments.