February 03, 2022
Cover Story
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Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.
February 03, 2022
Peer Reviewed
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In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.
February 03, 2022
Development
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Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.
February 03, 2022
Development
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Interest in natural phytochemicals or synthetic derivatives of cannabinoids has risen.
February 03, 2022
Manufacturing
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Training is crucial for supporting GMP operations in commercial-scale bioprocessing.
February 03, 2022
Manufacturing
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Getting started with a PAT framework enables automation with digital technologies.
February 03, 2022
Manufacturing
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For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.
February 03, 2022
Quality/Regulations
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With data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices.
February 02, 2022
Analytics
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Automated analytical workflows require advanced technologies to manage the higher volume of data output.
February 02, 2022
Ask the Expert
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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.
February 02, 2022
Quality/Regulations
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As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.
February 02, 2022
Regulatory Watch
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The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.
February 02, 2022
Regulatory Watch
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The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.
February 02, 2022
From The Editor
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As company revenues are gaining a boost from COVID-19, the issue of pricing is being debated once more.
February 02, 2022
From The Editor
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The process of reshaping inevitably leads to fresh insights.
February 02, 2022
Product Spotlight
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The ROSS VersaMix Triple Shaft Mixers offer fine dispersion, deagglomeration, emulsification, temperature control, and degassing.
February 02, 2022
Product Spotlight
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The SamuxMP enables routine quantification of empty/full AAV capsid ratios
February 02, 2022
Product Spotlight
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Sartorius’ Sartolab RF|BT 150–1000 vacuum filtration units provide fast, high-capacity filtration.
February 02, 2022
Product Spotlight
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Thermo Fisher Scientific's Triple Wrap Plates possess a unique Vapour-phase Hydrogen Peroxide (VHP) indicator for enhanced sterility and complete clean room and isolator confidence.