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Best Practices For Successful Filter Integrity Testing Using The Water Intrusion Test (WIT) Method

Hydrophobic filter cartridges which utilize sterilizing-grade polyvinylidene fluoride or polytetrafluoroethylene membranes are widely used in the pharmaceutical industry to sterilize compressed air or gases for product contact, as well as acting as sterile tank vents. However, hydrophobic membranes can also make filter integrity testing in situ difficult, as the membrane must be fully wetted prior to testing by the widely accepted integrity test methods of Bubble Point and Forward Flow. The Water Intrusion Test (WIT) is widely accepted within the…

Increasing Protein Yield – Optimization of Suspension CHO Transient Transfection

with Dr. Laura Juckem High-efficiency transient transfections of suspension- adapted Chinese hamster ovary (CHO) cells enable researchers to bridge upstream and downstream processes. This helps to provide confidence that a recombinant protein will have the same properties throughout its development as a biologic. As drug targets become increasingly complex, proper protein folding and posttranslational modifications become more relevant. Early upstream work with the same cell type — e.g., CHO instead of HEK 293 cells — ensures similar product quality from…

Tabular Data for “Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence”

Supplemental Tables The authors compiled a list of key cell therapy bioprocessing technologies through expert-user interviews; reviews of trade and industry literature; and discussions with technology manufacturers. Then they obtained technical specifications from publicly available documents and (whenever possible) confirmed them with the technology manufacturers to ensure their accuracy. Here are their results! Due to the size of the table structure, we were unable to print these results within our Cell Therapy Supplement, in March 2014. We instead have posted…

Electrophoresis: Analysis By Size and Charge

BPI Lab An essential method in modern analytical laboratories, electrophoresis separates macromolecules (DNA, RNA, and proteins) for analysis based on their size and charge. The popular sodium-dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) technique uses a gel medium. Capillary electrophoresis (CE) can separate ionic species by charge and hydrodynamic radii as well as frictional forces in small electrolyte-filled capillaries. Cheryl Scott looks at the history and applications of these techniques, highlights their appearance in past BPI articles, and points to some…

Localized Surface Plasmon Resonance for Bioprocess Development, Manufacturing, and Validation

Vendor Voice in this preprint from our September 2011 issue, authors from Lamdagen describe a new label-free sensor platform for bioprocess development, monitoring, and validation during therapeutic antibody manufacture. The technology, referred to as localized surface plasmon resonance (LSPR), is made possible through the creation and use of nanostructured metallic films. The two areas most likely to benefit from this new technology are process development and monitoring and Quality Control. More effective process development efforts can lower costs of therapeutic…

Implementation of the ASTM Standard for Manufacturing Systems Verification

Example Documents Many companies use risk assessments, yet their test protocols remain bloated and cumbersome, with a focus on protocol adherence rather than verification of system functionality. In the September 2011 issue, Peter Watler introduces the ASTM E 2500-07 international industry consensus standard for conducting risk-based design and qualification of GMP manufacturing systems.It uses risk- and science-based practices to focus on critical aspects affecting equipment systems throughout their design-qualification-operation lifecycle.This moves the process from a rigid, protocol-enforced accumulation of documentation…