INSIGHTS ON QUALITY CONTROL
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Nitrosamine Impurities Deadline: Are Your Products Compliant?
Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.
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Detecting Drug-Excipient Incompatibility In Pharmaceuticals
Here, we focus on how the apparent melting approach can provide a rapid screening protocol for the detection and analysis of drug-excipient incompatibility in mixtures and formulas.
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Studying Analyte Binding To Syringe Filters During Filter Validation
Filter validation is a critical part of various pharmaceutical QC tests. Since QC tests require accurate analyte quantitation, analyte binding is an important factor.
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Modernizing Compendial SEC Methods For Biotherapeutics
Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.
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Why Biological Indicators Survive A Validated Cycle5/10/2022
We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive.
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Biological Indicators And The European Pharmacopoeia5/10/2022
Here, we review the information concerning biological indicators in European Pharmacopoeia General Chapter 5.1.2, which is more detailed and covers a wider scope than the previous version.
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DSC Characterization Of Crystalline Structure: Apparent Melting5/5/2023
Here, we compare theory and results for thermodynamic and apparent melting and explain why it is important to distinguish between them when interpreting results from DSC.
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Comprehensive Peptide Mapping Of Protein Therapeutics8/31/2023
Explore how the peptide mapping workflows templates provided by a software designed for the characterization of biotherapeutic digests alongside data visualization and interrogation.
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Key Strategies For MES Software Integrations1/4/2023
To stay competitive in an increasingly dynamic field, pharma and biotech manufacturers are implementing numerous beneficial technologies to automate and streamline production. Explore the power of MES integration.
QUALITY CONTROL SOLUTIONS
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Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.
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Explore a wide variety of DHR temperature systems and accessories, designed for superior performance and ease-of-use.
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As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP 2.6.7 and USP 63 as both broth and agar plates. These ready-to-use Friis, Frey, and Hayflick culture media help to make the cumbersome compendial procedures of testing cell cultures, raw materials, intermediates, and final products for mycoplasmas easier.
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Trust Cambrex's analytical development and testing experts to rapidly advance your biologic for the greatest chance of success. Led by our broad experience and collaborative approach, we are committed to finding the shortest, most efficient path to success for our customers.
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The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.