December 03, 2023
Cover Story
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The bio/pharmaceutical industry is struggling with the challenge of staffing and training.
December 03, 2023
Development
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Matching excipients to API properties is essential.
December 03, 2023
Manufacturing
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Collaboration is a key component to achieving long-term success with genetic medicines.
December 03, 2023
Manufacturing
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Digital transformation allows for smarter and connected biomanufacturing operations.
December 02, 2023
Analytics
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Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
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.
December 02, 2023
Quality/Regulations
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Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.
December 02, 2023
Outsourcing
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The rising complexity of clinical research protocols has necessarily expanded the CRO landscape.
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.
December 02, 2023
From The Editor
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Drug shortages across Europe are being exacerbated by increased demand, struggling supply chains, and manufacturer suspensions.
December 02, 2023
Regulatory Watch
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What does the 2024 VPAS mean for pharma?
December 02, 2023
Regulatory Watch
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FDA and industry face unprecedented political and policy challenges.
December 02, 2023
From the CEO
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Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.
December 02, 2023
Ask the Expert
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Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
December 02, 2023
Product Spotlight
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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.
December 02, 2023
Product Spotlight
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Suncombe’s IsolatorCIP automatic cleaning systems provide aqueous, detergent, and/or solvent cleaning of glovebox isolators.