INSIGHTS ON QUALITY CONTROL
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Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2
Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.
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HPLC Autosampler Performance I: Challenging USP Methods
In this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.
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Accelerate Your R&D And QC With These 3 Key Analysis Methods
Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis.
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China
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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Advancing Cell Therapy Manufacturing: Rapid Sterility Testing5/7/2024
The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.
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Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres12/30/2024
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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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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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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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.
QUALITY CONTROL SOLUTIONS
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Combination Powder and Fume Hood with HEPA filtration and house exhaust connection designed to process liquid and powder substances. Fume Hood designed to house stir plate and analytical balance. It features cup sink; air, water, and gas fittings; and alarm for monitoring and maintaining recommended face velocity of 75 LFPM. Fume and Powder Hoods separated by sliding door to eliminate cross-contamination during processing. Powder Hood uses front airfoils and rear plenums to maintain laminar airflow across the work surface, which is vented through a HEPA filtration system to house exhaust.
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Discover how microbial testing services can streamline QC workflows, ensure regulatory compliance, and reduce resource strain with tailored equipment and expert support.
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Discover the advantages of an intuitively simple HPLC system developed specifically for biopharmaceutical quality control laboratories.
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In an increasingly competitive environment, working with the right CDMO is vital for successful drug lifecycle management. We now serve more than half of the world’s leading biopharmaceutical companies, sharing their mission to expedite patient access to life-saving biologics.
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FMS/BioTrak/Portable/Remote/Environmental Sensors