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Pharmaceutical Technology, July 2023
Gaining a Deeper Understanding of Aseptic Needs
July 03, 2023
Cover Story
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To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.
Navigating the Formality Spectrum in ICH Q9(R1)
July 03, 2023
Quality/Regulations
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The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.
In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance
July 03, 2023
Peer-Reviewed Research
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FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.
Overcoming Analytical Challenges in High Potency Formulation
July 03, 2023
Development
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Sample dilution, sensitivity, excipient interference, and containment are key issues that must be addressed.
Automation Aids Cell and Gene Therapy Production
July 03, 2023
Manufacturing
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Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.
Monitoring for Microbes
July 02, 2023
Analytics
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Data from environmental monitoring can assist in keeping sterile environments sterile.
Good Practices for Data Integrity
July 02, 2023
Analytics
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Automation can be balanced with operator oversight.
Understanding Nitrosamine Impurities in the Pharmaceutical Industry
July 02, 2023
Outsourcing
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Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.
Top 10 Considerations when Meeting with Regulators
July 02, 2023
Quality/Regulations
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Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.
Improvements to EMA’s PRIME Designation Scheme
July 02, 2023
Regulatory Watch
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Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.
New Deal on the Horizon
July 02, 2023
From The Editor
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The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.
Drug Shortages Continue to Plague FDA and Manufacturers
July 02, 2023
Regulatory Watch
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Problems continue despite actions by regulators to better prevent and address drug shortages.
The Inspection Result: Warning Letters and Form 483s
July 02, 2023
Ask the Expert
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FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.
Innovation Idolatry
July 02, 2023
From The Editor
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If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.
Drug Pricing’s Static Changes
July 02, 2023
From the CEO
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The debate surrounding drug pricing changes rages on.
Custom-Fabricated Processing Tools
July 02, 2023
Product Spotlight
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Ross Engineering custom fabricates tanks, pressure vessels, and reactors for various manufacturing and storage functions.
Ultra-Low Sample Optimized Mass Spectrometer
July 02, 2023
Product Spotlight
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Bruker Corporations timsTOF Ultra mass spectrometer features a captive spray ionization ino sources that provides optimized vortex gas flow.
Nasal Spray Fill/Finish Machine
July 02, 2023
Product Spotlight
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TurboFil Packaging Machines Mini-Monoblock MDN-50 is designed to accurately and expediently fill, seal, cap, and label spray multi-dose nasal dispensers.
High-Throughput Phototrophic Organism Screening Module
July 02, 2023
Product Spotlight
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Beckman Coulter Life Sciences’ Light Array Module enables high-throughput screening and process optimization for various phototrophic organisms.
Frontrunner in Therapies for Complement-Mediated Diseases
July 02, 2023
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A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.