INSIGHTS ON LIQUID DOSE MANUFACTURING
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Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process
Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.
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Explore A High-Performing Basal Medium And Feed Pairing
A customer sought to replace a chemically defined CHO medium with a more efficient medium and feed pairing strategy in bioreactors.
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Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing
Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.
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Safeguarding Biologic Integrity Through Enhanced Component Compatibility
For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.
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A Standardized Gloveless Robotic Isolator10/16/2024
By eliminating human intervention—the primary risk factor compromising drug sterility and quality—gloveless aseptic processing technology offers manufacturers greater flexibility, safety, and regulatory compliance in their filling operations.
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A Risk-Based Decision Framework For Selecting Aseptic Barrier Technologies3/20/2026
EU GMP Annex 1 requires a risk-based approach to selecting Isolators or RABS. This framework evaluates human intervention and decontamination to ensure robust sterility assurance.
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Practical USP <1665>/<665> Guide To E&L Risk Assessment2/17/2026
A practical USP <1665> and <665> framework helps manufacturers evaluate and manage extractables and leachables risk, supporting quality, safety, and regulatory compliance.
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The Successful Implementation Of A New Aseptic Filling Line10/10/2024
Discover how a Quality by Design approach can streamline the development of new sterile product filling lines, featuring a real-life example illustrating its effectiveness.
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Navigating Your Holistic Approach To CCI For Biologic Drug Products6/12/2024
Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.
LIQUID DOSE MANUFACTURING SOLUTIONS
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The addition of global Sterile Fill-Finish and extensive lyophilization capabilities ensures that we are able to build on our enviable reputation and deliver on our promise of delivering life-changing therapies to patients worldwide.
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Sterile fill-finish and device assembly capabilities span global sites, offering scalable solutions, analytical testing, and regulatory compliance for combination products and small-batch technical programs.
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Maximize glove testing efficiency
Improve your glove testing with the FZ-GTS 4.0. This innovative system delivers unmatched flexibility to adapt to your testing needs, seamlessly integrating with existing workflows for increased efficiency.
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Reusable Process Challenge Device (PCD) designed for routine monitoring of pre-vacuum steam sterilizers.
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The Isolator Glove Testing System enables for Annex 1 compliant wireless and tubeless leak testing of gloves installed in Isolators or RABS. The GTS with the latest software technology offers an extremely flexible and fully integrable solution for glove testing as part of glove management.