INSIGHTS ON QUALITY CONTROL
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What Is LearnGxP?
Stop the cycle of "click-through coma" in GXP training. Discover how scenario-based learning and role-specific curricula reduce compliance risks and drive meaningful engagement.
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Accelerate Biologics Product Release With Seamless Viral Testing
Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.
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Antibody-Drug Conjugates – Catalysts For Chemistry
Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.
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Ensuring Performance And Compliance: Successful FAT Of Filling Line Isolator For Creative Lifesciences, Taiwan
Rigorous Factory Acceptance Testing ensures filling line isolators meet performance and safety standards. This validation is vital for aseptic integrity and protecting both product and operator.
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Aggregate Analysis Of Tirzepatide12/11/2025
A new size exclusion method effectively analyzes Tirzepatide aggregates, demonstrating robust separation and reproducibility with minimal need for organic solvents or acidic modifiers.
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Leveraging A Modern HPLC System For Peptide Drug Substances Analysis8/22/2024
This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China11/11/2024
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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A Powerful Non-Destructive Tool For Tablet Characterization10/6/2025
Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.
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Quantifying Endotoxins Via Absorbance Or Fluorescence3/20/2026
Find out how endotoxin assays use Factor C activation to generate measurable absorbance or fluorescence signals, with guidance on selecting detection formats and implementing scalable workflows.
QUALITY CONTROL SOLUTIONS
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PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.
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The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
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Secure your laboratory environment when handling infectious materials. High-containment systems provide leak-tight protection for BSL 2+ through 4 applications, ensuring operator safety.
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A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).
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Grow and scale up your manufacturing with the right support, and choose from 92,000+ chemicals provided through an extensive global network of 3,500+ manufacturers.