INSIGHTS ON LIQUID DOSE MANUFACTURING
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Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance
Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.
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Meet Regulation Requirements With RTU Vials And Cartridges
Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.
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Maintaining Sterility Through Precise Component Design And Manufacture
Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.
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Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs
Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.
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Contamination Control Strategies: Comparing Cleanrooms, RABS, Isolators10/20/2025
Sterile manufacturing relies on three main contamination control strategies (CCSs): cleanrooms, RABS, and isolators. Understand how each system compares in sterility assurance, startup cost, and operational flexibility.
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Compressed Gas Systems In Aseptic Manufacturing10/18/2024
Learn about compressed gas systems and why effectively identifying and managing the risks associated with these systems is critical for maintaining product quality and ensuring compliance with GMP.
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Responding To Fill-Finish And Automation Scale-Up Challenges5/21/2025
Behind every life-saving cell therapy is a complex manufacturing journey. Examine the critical role of automation in overcoming production challenges and ensuring quality.
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Ensuring Product Safety And Purity With Mycoplasma And Sterility Testing10/7/2024
Discover how the Applied Biosystems™ MycoSEQ™ Plus system and Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing System can help accelerate your cell therapy manufacturing process.
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EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging8/27/2024
Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.
LIQUID DOSE MANUFACTURING SOLUTIONS
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Versatile tube welding where you need it most.
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Suitable for a variety of glass containers including ampoules, vials, cartridges and syringes, CVT Core is the best-in-class choice for companies inspecting challenging high value drugs, such as suspensions, viscous drugs, foaming liquids or lyophilized products.
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Used 10 sq meter (107 sq ft) Telstar Freeze Dryer, model Lyomega 100GN2, stainless steel construction, front loading/unloading with access door, with (10) 90 cm wide x 120 cm deep usable shelves, (11) total shelves, external condensor, stoppering with top mounted hydraulic ran with pump, refrigeration and vacuum skid with Cumulus PX20 refrigeration package, (2) 2.2 kw Telstar vacuum pumps with (1) 1.7 kw Aerzen booster pump, integrated control panel with Allen Bradley SLC 5/05 PLC controller, and external hmi control, serial# 231796. Built 2006.
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Cell and gene therapies have increased in popularity in recent years, and thanks to their ability to provide one-time treatments these therapies will play a significant role in treating some of the world's most challenging diseases. These drug products treat patients afflicted with genetic disorders and cancers by targeting the source of disease and altering its genetic makeup to eliminate its cause or symptoms. These therapies are expensive and complex and have been proven effective in numerous cases, but they present a challenge in producing them at scale and at a reasonable cost.
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BPCs are single-use, flexible container systems commonly used for critical liquid-handling applications in the biopharmaceutical industry.