As biosimilars move into the forefront of consciousness in the biopharmaceutical industry, analytical methods, especially comparability studies, have an increasingly important role to play. Additionally, as more products progress from phase 1 to 2–3 studies and require production-scale manufacturing, analytical methods are an important component of technology transfer or in-house scale-up efforts. The Analytical Methods for Biologics track will elucidate these challenges, and will include discussions about the latest changes in immunogenicity guidance, posttranslational modifications, analytical strategies, comparability testing, and…
April 2008
Products, Services, and Literature
Process Monitoring Product: SciLog conductivity, pressure, and temperature (pictured) sensors Applications: In-line single-use purification monitoring Features: Sensors come with embedded memory with stored IDs, serial numbers, lot numbers, calibration, and any calibration offsets. Products are cleanable with NaOH or sterilizable by autoclaving, ethylene oxide, or gamma irradiation. Sensors and monitors document parameter changes during processing and send them to a printer, programmable logic controller (PLC), or to a spreadsheet on a personal computer. They come in a variety of sizes…
BioProcess International Analytical and Quality Summit
This event offers key strategic insights from industry leaders regarding assay qualification and validation optimization, improvement of the pace and quality of analytical results, and improvement of product quality through increased process understanding. It brings together three conference programs including The 4th Annual Analytical Method Validation, the 2nd Annual Biophysical Analysis for Bioprocessing, and IBC’s 5th Annual Process Quality Forum on Process Characterization and Control. Analytical Method Validation This event gives assay development and validation scientists a broad view of…