INSIGHTS ON QUALITY CONTROL
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Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications
Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.
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Detection And Quantification Of Amorphous Content In Materials
Complementary analytical techniques like DSC, MDSC, cRHp, DVS, and SolCal accurately quantify amorphous content in pharmaceuticals to ensure stability, compatibility, and efficiency.
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Advancing Cell Therapy Manufacturing: Rapid Sterility Testing
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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Aseptic Expertise And Delivery Of Services
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance12/9/2024
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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Monitoring Microbial Contamination Of Mammalian Cell Cultures2/21/2025
Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.
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Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC1/21/2026
Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.
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CMO Validation As A Service8/20/2024
Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.
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Experience The Future Of Bioseparations4/16/2024
Learn about an HPLC System designed to improve outcomes in QC labs with ease of use and simplicity at its core.
QUALITY CONTROL SOLUTIONS
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Airborne ultrasound is a referenced technology in the new USP <1207> Chapter Guidance as a deterministic test method for seal quality testing, is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality integrity testing.
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Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer, benchtop design, serial# 38716.
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Discover the advantages of an intuitively simple HPLC system developed specifically for biopharmaceutical quality control laboratories.
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Developed for plasma protein binding determination and free fraction analyses, the Supel™ BioSPME 96-Pin Devices greatly improve upon the speed and simplicity of current sample preparation techniques.
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Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.