INSIGHTS ON QUALITY CONTROL
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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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0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?
Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.
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The Importance Of Having A Strong Reject Characterization Program
Discover how linking inspection results to systematic defect analysis strengthens data integrity, accelerates root cause resolution, and satisfies regulatory process knowledge requirements.
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Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
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Development To Large-Scale cGMP Production7/25/2024
For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.
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Vial Breakage During Lyophilization: Root Causes And Mitigation10/16/2024
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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Glucagon-Like Peptide-1 (GLP-1) Analogues Applications Notebook12/11/2025
View this collection of application notes about the chromatographic analysis and purification of GLP-1 analogues, including Semaglutide, Tirzepatide, Liraglutide, and Exenatide.
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Lessons From FDA 483s And Warning Letters: Cleanroom Compliance12/8/2025
Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
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The Hidden Costs Of Paper Logbooks3/19/2026
Stop losing time and capacity to manual paperwork. Learn how digital workflows eliminate compliance risks and unlock the actionable data needed to optimize life sciences manufacturing.
QUALITY CONTROL SOLUTIONS
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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.
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Advance organizational expertise with structured training designed for technical mastery. Explore specialized lessons that empower teams to optimize complex workflows and maintain compliance.
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Learn how high‑potency infrastructure, strong impurity control, and scalable payload‑linker capabilities help teams manage risk, maintain purity, and advance toward clinical‑stage ADC development.
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The X2 and X6 Packaged X-ray Inspection Series enhance safety by detecting contaminants and improving product quality with advanced technologies, supporting productivity, compliance, and brand protection.
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Mikart’s small-scale non-GMP lab accelerates development by enabling rapid testing and iteration at a lower cost.