INSIGHTS ON QUALITY CONTROL
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Practical Solutions For Protein Analytics And Residual DNA Testing
Discover practical solutions for common quality control bottlenecks in biotherapy manufacturing. Learn how to improve protein analytics and DNA testing robustness and accelerate time to market.
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Vial Breakage During Lyophilization: Root Causes And Mitigation
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.
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Optimizing Contamination Control: Strategy Planning And Execution
A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.
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Development Of Separation Methods For GLP-1 Synthetic Peptides
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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Antibody-Drug Conjugates – Catalysts For Chemistry5/16/2024
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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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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How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows2/3/2025
The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.
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Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance6/6/2024
Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.
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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.
QUALITY CONTROL SOLUTIONS
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Applied Biosystems genetic analyzer, model 3500, integrated autosampler, 120 volts, serial# 24158-161.
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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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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.
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Downflow Booth for Freeze Dryer/Lyophilizer designed for product protection when conducting vial-filling and loading vialed product into a freeze-dryer. Features a 304 stainless steel alloy superstructure and perforated stainless steel base.
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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.