INSIGHTS ON QUALITY CONTROL
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The Seamless Path To Market: End-To-End CDMOs As Your Strategic Ally Douglas CDMO
Partner with an experienced end-to-end CDMO to streamline development, reduce risk, and accelerate your drug’s path to market in today’s complex and competitive pharmaceutical landscape.
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Improved GLP-1 Receptor Agonist Peptide Recovery
Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.
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Leveraging A Modern HPLC System For Peptide Drug Substances Analysis
This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.
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Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability
Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Antibody Drug Conjugates and enhance ADC development processes.
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Building A Connected Quality And Manufacturing Ecosystem In Life Sciences12/27/2024
Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.
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Change Management In Pharmaceutical Quality Control Laboratories10/29/2024
Gain expert insights into the driving forces behind change management, the associated obstacles within a QC lab, and best practices for guiding change when implementing new technology or procedures.
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Aseptic Expertise And Delivery Of Services8/20/2024
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance12/9/2024
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety7/23/2025
Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.
QUALITY CONTROL SOLUTIONS
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The Powder Rheology Accessory expands the DHR’s capabilities to powders, enabling the characterization of behaviors during storage, dispensing, processing, and end-use.
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Discover a 21 CFR Part 11-compliant digital validation platform designed for conducting IQ & OQ on your microbial QC testing systems dedicated to bioburden testing, sterility testing, and air monitoring.
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In pharmaceutical testing, the development and validation of analytical methods are absolute musts when it comes to reliable quality control. Natoli Scientific is at the forefront of offering comprehensive analytical method development and validation services designed to ensure the integrity of your company’s drug formulations. Our expert team develops robust methods tailored for each unique compound, with an approach that emphasizes precision, accuracy, sustainability, and compliance with regulatory standards such as the FDA and ICH guidelines. These methods are meticulously validated to confirm their reliability across a range of analytical parameters including specificity, sensitivity, linearity, and reproducibility.
This validation process is critical for verifying that our methods produce consistent, trustworthy results throughout the product’s lifecycle, thus fostering confidence in the safety and efficacy of pharmaceutical products.
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Automatic Tablet Press Enclosure designed to provide personnel protection tablet pressing operations involving a Carver Press 800 ANE with dimensions 35.43” x 23.62” x 39.37 [900mm X 600mm X 1000mm]. Enclosure features a polypropylene superstructure, black phenolic base dished to contain spills, and (3x) removable sliding doors for easy loading/unloading of equipment and processed product.
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API Process Development System designed to provide personnel and product protection while working with powder and liquid substances. Designed to house a Mettler Toledo Easy Max 102, Vacuum Oven, and IKA LR 1000.