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Pharmaceutical Technology, December 2023
Training for Operational Excellence
December 03, 2023
Cover Story
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The bio/pharmaceutical industry is struggling with the challenge of staffing and training.
Selecting Excipients for Enhancing Solubility of Hot-Melt Extrusion Formulations
December 03, 2023
Development
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12
Matching excipients to API properties is essential.
Risks and Rewards of Investing in RNA-based Genetic Medicine Manufacturing
December 03, 2023
Manufacturing
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12
Collaboration is a key component to achieving long-term success with genetic medicines.
Revolutionizing Biomanufacturing: The Digitalization Advantage
December 03, 2023
Manufacturing
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Digital transformation allows for smarter and connected biomanufacturing operations.
Stability Studies: An Essential Step for Quality Management in Drug Development
December 02, 2023
Analytics
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12
Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
Establishing a Framework for Reliable Pharma Labeling
December 02, 2023
Analytics
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By taking a strategic and evidence-based approach, companies can leverage the insights gained from stability studies to establish robust labeling.
Revitalizing Quality Management Processes through Digitalization
December 02, 2023
Quality/Regulations
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12
Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.
Elaboration, Expansion, and Evolution in Outsourcing of Clinical Research
December 02, 2023
Outsourcing
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The rising complexity of clinical research protocols has necessarily expanded the CRO landscape.
The ICH Q9 Revision and a Renewed Focus on Quality Risk Management Fundamentals
December 02, 2023
Special Report
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The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.
Falling Short
December 02, 2023
From The Editor
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12
Drug shortages across Europe are being exacerbated by increased demand, struggling supply chains, and manufacturer suspensions.
Renewing the UK Voluntary Pricing Scheme
December 02, 2023
Regulatory Watch
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12
What does the 2024 VPAS mean for pharma?
Signing Off from Washington
December 02, 2023
Regulatory Watch
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12
FDA and industry face unprecedented political and policy challenges.
The Dislocation of Progress
December 02, 2023
From the CEO
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12
Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.
Final Product Inspection: Making the Most of Your Processes
December 02, 2023
Ask the Expert
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12
Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Ribbon Blenders
December 02, 2023
Product Spotlight
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12
ROSS’ Ribbon Blenders are designed to handle a wide range of dry materials and effectively coat individual solid particles, keeping long-term performance and quality in mind.
Automatic Cleaning System
December 02, 2023
Product Spotlight
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12
Suncombe’s IsolatorCIP automatic cleaning systems provide aqueous, detergent, and/or solvent cleaning of glovebox isolators.