September 03, 2022
Cover Story
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The flow of capital and scientific acuity irrigates this pharm system.
September 03, 2022
Manufacturing
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Biopharmaceutical manufacturers must consider a surprisingly wide range of factors when deciding where to turn for assistance with cell line development.
September 03, 2022
Peer-Reviewed Research
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It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.
September 03, 2022
Supply Chain
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Expanded use of data analytics can help to avoid disruptions, but the possibilities cannot be realized without sufficient investment and direct human involvement.
September 03, 2022
Development
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API permeation into the skin modulates the efficacy of topical treatments.
September 03, 2022
Development
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It is possible to overcome some of the limitations of traditional dosage forms by employing alternative drug delivery formulation strategies.
September 02, 2022
Quality/Regulations
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The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
September 02, 2022
Analytics
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Cleanroom monitoring may be in a state of flux after many recent technological advancements.
September 02, 2022
Operations
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By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
September 02, 2022
Outsourcing
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It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.
September 02, 2022
Quality
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Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
September 02, 2022
Quality/Regulations
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EMA has announced a change of plan for the IDMP.
September 02, 2022
From The Editor
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More than anything else MonkeyPox and COVID-19 have shown that we are interdependent, no matter what continent you call home.
September 02, 2022
Regulatory Watch
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A new unitary patent system is due to come into effect in Europe later on this year.
September 02, 2022
From The Editor
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As winter approaches, the next generation of COVID-19 vaccines are being prepared and scheduled, ready for distribution across Europe and the world.
September 02, 2022
Ask the Expert
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A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.
September 02, 2022
Product Spotlight
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The ROSS Vertical Blender enables mixing of friable solids.
September 02, 2022
Product Spotlight
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Shimadzu’s Nexera XS inert is designed to prevent both adsorption of target molecules to metal surfaces and mobile-phase corrosion.
September 02, 2022
Product Spotlight
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Cellefill is a vial fill/finish system that designed to promote flexibility via an integrated barrier solutions.
September 02, 2022
Product Spotlight
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Qosina’s AseptiQuik STC Series enables flexibility between hybrid stainless steel and single-use processing equipment.
September 02, 2022
From the CEO
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While the cost of certain medicines are alarmingly high, they can be considered a bargain measured against a lifetime of traditional costs.