FEATURED ARTICLES
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DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
WHITE PAPERS & CASE STUDIES
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Crude Peptide Purification Optimization For Scalable Manufacturing
Transitioning lentiviral vectors to final drug product raises quality demands. A simplified membrane-based capture step minimizes downstream losses that can constrain systemic dosing.
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Getting Started On A Successful Path To Microbial QC Automation
Moving microbial QC toward automation involves team-building, facility readiness, staff concerns, validation, regulatory alignment, and cost justification that extends well beyond simple labor savings.
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Comparative Evaluation Of NHP And VHP For Isolator Decontamination
Comparative evaluation reveals how optimizing hydrogen peroxide cycle parameters improves pharmaceutical isolator bio-decontamination efficiency while maintaining Annex 1 sterility compliance.
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Reduce Complexity, Not Quality In CAR T Cell Manufacturing
Fragmented CAR T cell manufacturing workflows drive up costs and extend timelines. This case study quantifies what consolidating manufacturing and QC through automation actually delivers.
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Developing A Science- And Risk-Based Bio-Decontamination Control Strategy For Pharmaceutical Isolators
Modern contamination control links barrier design, bio-decontamination science, and risk-based validation to ensure reliable surface sterility.
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FM Approval Standard 4882
A fire in a pharmaceutical cleanroom can be contained, but for sterile manufacturers, smoke can turn a localized event into a far wider decontamination, requalification, and production-recovery challenge.