FEATURED ARTICLES
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![Finding the hidden costs-GettyImages-1478035639]( "DEA Reveals Hidden Costs Of Analytical Validation Guidelines")
DEA Reveals Hidden Costs Of Analytical Validation GuidelinesBy 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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![GettyImages-1219370954-scientist-in-lab-with-cell-culture]( "Reduce Complexity, Not Quality In CAR T Cell Manufacturing")
Reduce Complexity, Not Quality In CAR T Cell ManufacturingFragmented 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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![GettyImages-2150276083-lab-mask-tablet-PPE-cleanroom]( "Developing A Science- And Risk-Based Bio-Decontamination Control Strategy For Pharmaceutical Isolators")
Developing A Science- And Risk-Based Bio-Decontamination Control Strategy For Pharmaceutical IsolatorsModern contamination control links barrier design, bio-decontamination science, and risk-based validation to ensure reliable surface sterility.
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![Audit and inspection-iStock-1205235181]( "FM Approval Standard 4882")
FM Approval Standard 4882A 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.
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![DSC00550]( "The Strategic Value Of In-House Delumping For Homogeneous API Production")
The Strategic Value Of In-House Delumping For Homogeneous API ProductionAPI batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.
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![GettyImages-1938555153 tablet, lab]( "Enhancing Quality And Environmental Monitoring Efficiency Through Paperless Sampling")
Enhancing Quality And Environmental Monitoring Efficiency Through Paperless SamplingAt roughly 600,000 samples per year, manual EM documentation creates real compliance and operational risk. This whitepaper details how a fully integrated digital sampling system addresses both.
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![data search, information discovery, file management, digital analysis, and advanced data retrieval systems-GettyImages-2284270263]( "Digital CMC Maturity: Rethinking QTTP And Control Strategy")
Digital CMC Maturity: Rethinking QTTP And Control StrategyDigital CMC maturity depends on structured, science- and risk-based knowledge. Learn how connecting development, validation, regulatory, and lifecycle information can accelerate timelines.
PRODUCTS & SERVICES
Advanced positive-pressure isolators with integrated nebulized decontamination protect sensitive cell processing and aseptic filling operations while ensuring strict cGMP compliance.
Scale medical device assembly with a compact system designed for clinical trials and small batches. Optimize parameters and simplify device changeovers.
Scale oral solid dose production with a modular capsule filling system featuring rapid trolley changeovers, high-containment isolation, and inline weight verification.
Safely scale potent capsule encapsulation with high-containment isolation up to OEB 5, integrated wet-in-place cleaning, and 100% inline weight verification.
Our solutions have been specified in the testing process for the top two GLP-1 manufacturers
Bioanalytical organizations are responsible for generating accurate, reproducible data that supports development decisions, regulatory submissions and ultimately faster drug approvals. As sample volumes grow and studies become more complex, maintaining quality, compliance and efficiency can become increasingly difficult.
IDBS Polar Request brings lab work request management directly into the Polar platform—alongside experiment execution, structured workflows and compliance. It connects the demand for scientific work to the people, inventory and capacity needed to deliver it.
Synthetic oligonucleotide therapeutics, such as antisense oligonucleotides (ASOs) and small interfering RNAs (si-RNAs), require thorough analysis to establish purity and quality.