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Pharmaceutical Technology-03-02-2021
Pharmaceutical Technology
Genetic Vaccine Platforms Demonstrate Their Potential
March 03, 2021
Cover Story
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In a pandemic, genetic vaccines offer several advantages over traditional approaches.
Using Modified QbD to Develop a Novel Pediatric Formulation of Ezogabine
March 03, 2021
Peer-Reviewed Research
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The epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children.
Novel Excipients Needed More Than Ever Before
March 03, 2021
Development
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Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.
Reviewing Recent Bioavailability Research
March 03, 2021
Development
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Various strategies to improve bioavailability are being continuously evaluated, affording greater commercial prospects for the future.
Digital Tools Enhance Raw Material Traceability
March 03, 2021
Manufacturing
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Integrated, paperless data systems can improve efficiency and quality.
Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing
March 03, 2021
Manufacturing
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The need for real-time monitoring and control has spurred the development of new analytical tools.
Pandemic Spurs Cybersecurity Risks in Laboratories
March 02, 2021
Analytics
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Pharmaceutical laboratories must work to maintain lab data integrity practices as the pandemic surges on and cybersecurity risks increase.
Necessity Drives Just-in-Time Approaches to Clinical Trials Supply
March 02, 2021
Outsourcing
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The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.
FDA Documents Achievements and Plans for Future
March 02, 2021
Regulatory Watch
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Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.
Adapting Regulations Post-Brexit
March 02, 2021
Regulatory Watch
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The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.
Fighting Through This Slow Season of Change
March 02, 2021
From The Editor
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Bio/pharma works hard today to change the calendar to tomorrow.
Meeting CGT Demand
March 02, 2021
From The Editor
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More work is needed to ensure the rising demand for cell and gene therapy manufacturing capacity and required skilled workforce can be met in Europe.
Auditing for Good Distribution Practices
March 02, 2021
Ask the Expert
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Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.
Cell Culture Analyzer with Sample Retain Collector
March 02, 2021
Product Spotlight
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Nova Biomedical added a Sample Retain Collector (SRC) to its FLEX2 cell culture analyzer, which works to measure up to 16 tests including pH, gases, metabolites, osmolality, cell density, and cell viability.
Microbial Air Sampler
March 02, 2021
Product Spotlight
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Particle Measuring Systems introduced the MiniCapt Mobile Microbial Air Sampler, a monitoring instrument designed to prevent the introduction of bacterial contamination created during monitoring activities.
Chromatography Solution for Biologic Drugs
March 02, 2021
Product Spotlight
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The 3M Polisher ST from 3M Health Care is a single-use anion exchange (AEX) chromatography solution intended to replace the reusable AEX polishing column for biologic drug manufacturing.
ROSS Inline High Shear Mixers
March 02, 2021
Product Spotlight
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Inline high shear mixers from ROSS are available from 1 through 250 HP to accelerate mixing, emulsification, and homogenization in recirculation and continuous modes.