INSIGHTS ON QUALITY CONTROL
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![Cleanroom GettyImages-184293451]( "The Pain Of Change – Could Suppliers Be Part Of The Cure?")
The Pain Of Change – Could Suppliers Be Part Of The Cure?Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.
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![GettyImages-2036497889-lab-computer-research]( "Compliance To Confidence: Annex 1 For Small-Batch, High-Value Production")
Compliance To Confidence: Annex 1 For Small-Batch, High-Value ProductionGet strategies for meeting the updated GMP Annex 1 in small-batch aseptic filling. Learn about contamination control, quality management, and equipment design for high-value liquid and powder products.
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![Pipette With Cell Culture Plate-GettyImages-520238063]( "Automation-Assisted Washing Of Multicellular 3D Spheroids")
Automation-Assisted Washing Of Multicellular 3D SpheroidsAutomated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.
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![Syringe vaccine]( "Understanding cGMPs For Phase 1 Investigational Drugs")
Understanding cGMPs For Phase 1 Investigational DrugsLearn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.
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Innovative Technology For Developing, Scaling Peptide-Based Therapeutics11/18/2024
Watch as experts walk through several technologies and case studies, focusing on liquid-phase peptide synthesis, crystallization, method development for impurity analysis, and more.
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Monitoring Microbial Contamination Of Mammalian Cell Cultures2/21/2025
Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.
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Thermal Analysis In The Pharmaceutical Industry12/30/2024
Thermal analysis techniques provide valuable insights into pharmaceutical material properties, ensuring compatibility, stability, and quality control in drug development and production processes.
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Development Of Separation Methods For GLP-1 Synthetic Peptides6/30/2025
Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.
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Vial Breakage During Lyophilization: Root Causes And Mitigation10/16/2024
Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.
QUALITY CONTROL SOLUTIONS
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![Milliflex Quantum Rapid Detection System]( "Rapid Bioburden Testing System To Detect Microbial Contamination Earlier")
Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.
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![GettyImages-1214763114 Medical Research Scientist Working In Laboratory]( "Culture Media For Biological Indicators")
Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.
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![Lighthouse]( "Container Closure Integrity Testing Using Gas Ingress")
The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly-sensitive and non-destructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS Headspace Gas Analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.
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![Affinity-ITC]( "Microcalorimeters For In-Depth Characterization")
Powerful tools for characterizing protein-protein interactions, structural stability, and formulation compatibility.
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![GettyImages-1087219142 Scientist Using Digital Tablet Computer In Manufacturing Laboratory]( "Analytical Method Development And Validation")
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.
