PCI – 7th June 2024
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Current Features

Comparing Organoids and Patient-derived Xenograft Models for the Development of Antibody-drug Conjugates

Antibody-drug conjugates (ADCs) are one of the most rapidly expanding forms of oncology treatment and therapeutic successes have led to an unprecedented expansio...
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Lipid Nanoparticles (LNPs) for Nucleic Acid Delivery 

Lipid nanoparticles (LNPs) are one of the most prominent tools for nucleic acid delivery. Their versatility allows the encapsulation of different cargos (siRNA, ...
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Accelerating Cell Line Selection with Integrated Analytical Strategies

Cell line development is a critical determinant of success in biologics manufacturing. It lays the foundation for product yield, quality and long-term process st...
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Leveraging Strategic Partnerships to Enhance Flexibility in Facility Design and Bioprocesses

Flexibility is an operational imperative in today’s fast-evolving biopharmaceutical industry. Contract development and manufacturing organisations (CDMOs), as in...
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Turning the Temperature Up on Cold Chain Logistics

As biopharma therapies become more sensitive, costly and complex, traditional compliance frameworks are no longer enough. Real-time visibility and IoT innovation...
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Developing Endotoxin Limits, Risk Assessment and In-process Testing for CGT Products

Cell & Gene Therapy (CGT) products face a unique challenge in the required pyrogen testing for injectable wares. Since this test was written for conventional...
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Why Renting Product Inspection Systems Makes Strategic Sense for Pharma Manufacturers

Production lines don’t pause for procurement. When pharmaceutical manufacturers face a sudden spike in demand, new quality control requirements or equipment failure,...
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The Importance of Mass Spectrometry 

Mass spectrometry (MS) has long been a cornerstone analytical technique in the pharmaceutical and biopharmaceutical industries. Its ability to provide detailed molec...
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Plan, Lead, Deliver: A Framework for Regulatory Writing Success 

Q: Is your team simply writing a dossier, or are they following a clear strategy?A: The most effective teams do both, but strategy should come first. Preparing a sub...
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