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| Quality By Design In The Pharmaceutical Industry | White Paper | Siemens | Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage. |
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By Katie Anderson, chief editor, Pharmaceutical Online | Copy and paste may be frowned upon in most work tasks, but not in the case of “fleet management.” In the past few years, Roche and Novo Nordisk collaborated to introduce this concept of applying copy/paste action to standardized, decentralized facilities. | |
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INDUSTRY INSIGHTS CONTINUED |
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| Characterizing Binding Interactions By ITC | Application Note | TA Instruments | Isothermal Titration Calorimetry is a powerful technique for analyzing biochemical binding events, which is crucial for understanding molecular interactions and enzyme kinetics in biomedical research. |
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| New Standards For Elastomeric Components In Sterile Packaging | Article | By Christian Collazo-Sarra, Pace Life Sciences | USP’s new elastomeric packaging standards shift testing to full system‑level evaluation, strengthen integrity and usability expectations, and place compliance responsibility on drug developers. |
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| Alternative Endotoxin, Non-Endotoxin Pyrogen Test Method | Article | MilliporeSigma | The ability of the Mono-Mac-6 cell line to detect non-endotoxin pyrogens is sometimes questioned. To demonstrate its performance, tests have been performed using a wide panel of monocytic TLRs ligands. |
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| How To Mitigate Particulate Contamination In cGMP | Article | Thermo Fisher Scientific | Maintaining cGMP standards, controlling particulate contamination ensures drug safety, quality, effectiveness, and shelf life while preventing immune reactions and regulatory noncompliance. |
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| Operational Readiness Frameworks For Pharma And Biotech | Article | By Paige Kane, CAI | Achieving top performance in life sciences requires a continuous journey from Operational Readiness (OR) to sustained Operational Excellence (OE), ensuring safe startup and long-term efficiency. |
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