Build your biopharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from biopharma industry suppliers.

Five cGMP Mapping Resources

Rotronic Instrument Corp.

Five mapping resources to make your mapping project easier and more efficient. Learn about the proper number of sensors, calibration, warehouse mapping, regulations and guidelines, and choosing the best sensor.

Biotherapeutic comparability assessment of sequence and modifications by LC-MS/MS

Sean McCarthy, Sr. Market Manger, Biologics, Sibylle Heidelberger, Technical Marketing Manager, Biologics, SCIEX

Comparisons between biotherapeutic batches is of vital importance in the process of drug development and production. Peptide mapping by LC-MS gives a thorough comparison of modifications as well as of the protein backbone for sequence variation. Using the SCIEX X500B QTOF System, a comparison is made of two manufacturer lots of trastuzumab using a simple, yet powerful workflow.

Fully Automated Digestion, Separation and Analysis of the Human Prolactin Receptor Transmembrane Protein by LC-MS/MS

Shimadzu

Detection and quantification of peptides from transmembrane proteins is important for detection of biomarkers and new protein based drugs. This paper presents a fully automated online digestion and LCMS MRM analysis of two model transmembrane proteins, a method that improves reproducibility and decreases chances of contamination.

Development of a Two-Column Manufacturing Process for Adenovirus

Mark Fitchmun, Mark Snyder, and John Chicca, Bio-Rad Laboratories

Large-scale downstream processing of viruses for clinical applications poses challenges different from those of other biotherapeutics. These challenges arise from the size and complexity of the virus. This study presents purification results of a process developed for the manufacturing of a recombinant adenovirus.