INSIGHTS ON QUALITY ASSURANCE
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FDA Product Recalls: A Wake-Up Call For Life Sciences Manufacturers
Discover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.
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Scale-Up Of A Transient rAAV Production Process
Scalable rAAV production is achievable with a transient cell line and optimized bioreactor setup, delivering high titers and reduced impurities, now validated at 200 L scale for commercial readiness.
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The Transformational Impact Of A Digital Backbone
Relying on fragmented data becomes problematic when teams need to dissect cell line performance data and that data is not in a digital backbone.
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Navigating The Regulatory Space To Biosimilar Approval
The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.
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Advanced Aseptic Filling Assembly Helium Integrity Testing10/15/2025
Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.
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The Impact Of Annex 1 (2022) On Sterility Assurance4/24/2025
Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.
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Kneat Solutions Bio-Expo Live February 2025: Quality, Data, And Analytical Solutions3/17/2025
Discover how top pharma companies streamline validation, reduce cycle times by 40%+, and ensure compliance with a digital validation platform that also aids in real-time reporting and compliant testing.
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Ten Ways To Solve Your Document Review Headaches In Life Sciences7/15/2025
Struggling with document chaos in life sciences? Join James Wilding to uncover smart strategies and tools that streamline reviews, boost compliance, and enhance collaboration.
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Intensified Antibody Purification With Membrane Chromatography11/10/2025
Learn how membrane chromatography can help overcome downstream bottlenecks in mAb purification, reduce costs, and support process intensification from development to GMP scale.
QUALITY ASSURANCE SOLUTIONS
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Spreadsheets don't belong in your QbD process. Discover the ValGenesis iRisk platform that has a single repository to ensure easy access to your data, seamless data transition, smart detection for your areas of concern, and assessment reusability.
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The pharmaceutical industry continues to bring breakthroughs in the field of new vaccines and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.
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Reusable Process Challenge Device (PCD) designed for routine monitoring of pre-vacuum steam sterilizers.
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As your personal partner and pharma consulting expert, we sincerely understand the specific process and regulatory challenges of pharmaceutical, biotech, and medical device manufacturers in detail.
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Alconox, Inc. provides a range of validation information to help support the company's brands.