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Pharmaceutical Technology, October 2022
Adopting Smart Development Strategies
October 03, 2022
Cover Story
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10
External expertise is beneficial in helping companies select the right tools at the right stages of development to ensure success.
Application of F Charts in Continued Process Verification of OSD Forms
October 03, 2022
Peer-Reviewed Research
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10
This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.
Reformulating Success
October 03, 2022
Development
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There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.
Analyzing Extractables and Leachables in Single-Use Systems
October 03, 2022
Analytics
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10
Standardized risk assessment and analysis protocols facilitate the comparison of processing equipment components.
Improving Sterility Using Blow-Fill-Seal Technology
October 03, 2022
Manufacturing
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BFS technology can help maintain sterility during the biologics manufacturing process.
Electrochemistry for API Synthesis
October 03, 2022
Development
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10
Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing.
Shining a Light on Lipid Nanoparticle Characterization
October 03, 2022
Development
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10
Using an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.
The Future of Drug Delivery for Biopharmaceuticals
October 03, 2022
Development
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10
Some of the greatest advancements in drug delivery are related to disposable delivery devices, vaccine adjuvants, and wearable pumps, according to Nicholas W. Warne of Pfizer.
The State of Contamination Control
October 03, 2022
Manufacturing
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Various advances in contamination control are being utilized to reduce the chance pollutants contaminate a drug product.
Biologic Standards in the Pharmacopoeias: An Update
October 02, 2022
Quality/Regulations
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10
Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
Choosing the Right CDMO for CGT Programs
October 02, 2022
Outsourcing
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10
Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.
The Future of Pharmaceutical Environmental Monitoring in Europe
October 02, 2022
Manufacturing
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10
A blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.
Growth in Cell and Gene Therapy Market
October 02, 2022
Weighing Up Big Pharma
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10
Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.
A Royal Tribute
October 02, 2022
From The Editor
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10
Pharmaceutical Technology Europe pays tribute to the role Her Majesty Queen Elizabeth II had in promoting innovation within life sciences.
Securing Europe’s Critical Entities from Cyber Attacks
October 02, 2022
Regulatory Watch
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10
Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.
Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
October 02, 2022
Regulatory Watch
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10
FDA backs joint reviews, common research policies, and modern production methods around the world.
Industry’s Best Secret
October 02, 2022
From The Editor
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10
One can only learn the secrets of "fight club" by attending its meetings.
Regulatory Compliance Versus Real Compliance
October 02, 2022
Ask the Expert
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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.
Ergonomic, Safety-Focused Blenders
October 02, 2022
Product Spotlight
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10
ROSS Ribbon Blenders are a customizable solution designed to minimize risk and maximize productivity.
Inorganic DNA Replication Enzyme
October 02, 2022
Product Spotlight
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10
The new inorganic pyrophosphate from Canvax is intended for use in RNA IVT reactions.
Continuous Granulator with Integrated Dryer
October 02, 2022
Product Spotlight
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10
L.B. Bohle’s QbCon 1 is intended to meet all quality requirements for long granulation processing time.
Next-Generation Synthetic Biology Workflow Platform
October 02, 2022
Product Spotlight
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Codex DNA’s BioXp 9600 system is designed for the automated synthesis of synthetic biology workflows.
Optimizing Quality
October 02, 2022
From the CEO
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The 1VQ papers advocate for the idea that certain post-approval changes should be streamlined and expedited.