Insights On Quality Control
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Seamlessly Integrating An E-WorkBook With A Customer's LIMS
8/12/2024
Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.
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Effect Of X-Ray Inspection On Pharmaceutical Products
7/23/2024
Explore the use of X-ray inspection systems for the internal examination of pharmaceutical products, particularly non-transparent packaged drugs.
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Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres
12/30/2024
Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.
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Rapid Separation Of Circular RNA Using An mRNA Analysis Kit
8/11/2023
Achieve high-resolution separation of circular RNA (circRNA) species from linear RNA products, and detect impurities present at 0.1% of that main product, using an mRNA analysis kit.
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Manufacturing Solutions
3/4/2025
Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure exceptional quality and compliance with cGMP regulations.
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Mitigating CMC Issues Using A Holistic Approach To Developability Assessment
3/27/2025
Comprehensive chemistry, manufacturing, and control (CMC) developability testing is essential to mitigate the risk of costly late-stage failures and to proactively address potential challenges.
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ICH Q9 Revision 1: Enhancing Quality Risk Management
8/12/2024
ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.
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How To Unlock The Secret To Repeatable, Scalable Low Turnover
6/7/2024
Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.
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Strategic CMC Planning Through A Phase-Appropriate Quality Approach
5/28/2024
A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.
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Contamination Control Strategy With QRM Principles
11/19/2024
Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.