INSIGHTS ON REGULATORY COMPLIANCE
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Why And Where To Monitor In Aseptic Processing Areas
Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value.
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How Bend Bioscience Standardized Operations And Boosted Compliance
Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.
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Automation-Assisted Washing Of Multicellular 3D Spheroids
Automated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.
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A New Framework For Identifying Nitrosamine Risks And Derisking Products
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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Accelerate Production Through Digital Commissioning And Qualification12/17/2024
Watch to learn how digital validation streamlines commissioning and qualification (C&Q), improving productivity, compliance, and cost-efficiency across your organization.
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Developing A Comprehensive Regulatory Approach For LNP Drugs2/26/2024
The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
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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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PUPSIT As Part Of A Contamination Control Strategy (CCS)8/21/2024
Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.
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Ensuring AI Compliance In Life Sciences: 5 Critical Requirements7/24/2025
Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.
REGULATORY COMPLIANCE SOLUTIONS
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1,500 mL max rotor capacity 100,000 max RPM 802,400 x g
Security and tracking Remote monitoring and control eXPert simulation software.
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Gene therapies hold immense potential to provide long-lasting treatments for a wide range of diseases. At Cytiva, we offer GMP-compliant, end-to-end manufacturing solutions designed to support the development and commercialization of advanced medicines across multiple modalities – including AAV, adenovirus (AV), lentivirus (LV), plasmid DNA (pDNA) and exosomes. Our dependable suite of technologies and expertise ensures scalability, quality, and regulatory confidence at every stage of your journey.
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Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.
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Streamline maintenance with a paperless platform that boosts uptime, ensures GMP compliance, and improves efficiency through automation, mobility, and KPI-driven insights.
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The SCIEX Triple Quad™ 5500+ system is engineered to deliver best-in-class quantitative analysis.
The best just got better. The SCIEX Triple Quad™ 5500+ system is equipped to conquer your laboratory’s most complex workflows and opportunities. With this LC-MS/MS system, you have the sensitivity and performance to meet analytical and regulatory demands for low-level trace detection with ease.