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Pharmaceutical Technology, August 2022
What Goes Wrong When API Quality is Compromised?
August 03, 2022
Cover Story
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The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.
Mitigating the Risk from Excipient Variability
August 03, 2022
Special Report
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This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
Adapting to Solubility/Bioavailability Challenges
August 03, 2022
Development
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Industry is adapting to the increasing complexity and poor solubility and bioavailability of molecules in the pipeline.
Thermogelling Matrix-Containing Platelet Lysate-Loaded Elastic Liposomes as a Potential Treatment of Wounds
August 03, 2022
Peer-Reviewed Research
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The purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.
Progress in the Development of CAR NK-Cell Therapies
August 03, 2022
Development
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Further advances in construct design and manufacturing scalability are still needed.
Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine Manufacturing
August 03, 2022
Manufacturing
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This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
Vaccine Administration: The Growing Role of Prefilled Syringes
August 03, 2022
Manufacturing
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The option of using prefilled syringes for vaccinations is not (yet) available for all types of vaccines. Stakeholders are working to expand that option while also pursuing other non-traditional routes of administration.
Inspecting Finished Products with Precision
August 02, 2022
Analytics
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Automated finished product inspection has been widely adopted in the bio/pharmaceutical industry.
An Integrated Approach to the Data Lifecycle in BioPharma
August 02, 2022
Analytics
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Successful digital transformation in biopharma requires an integrated approach to the data lifecycle.
Detecting Apparent Total Nitrosamine Content in Pharmaceutical Drugs
August 02, 2022
Quality/Regulations
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Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.
Automating Packaging of Bio/Pharmaceuticals
August 02, 2022
Outsourcing
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Automation of pharmaceutical packaging saves costs and time, say contract packagers.
FDA Joins Effort to Curb Drug Patent Abuses
August 02, 2022
Regulatory Watch
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FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.
Navigating the Future
August 02, 2022
From The Editor
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Promising applications for targeted delivery may be cresting the horizon.
New Guidance on the Use of Real-World Evidence
August 02, 2022
Regulatory Watch
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Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.
Regulatory Applications for Biologics
August 02, 2022
Ask the Expert
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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.
Planetary Dual Dispersers for Viscous Batches
August 02, 2022
Product Spotlight
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The ROSS PDDM Planetary Dual Disperser offers flexibility in the form of removable disperser shafts.
Multipurpose Lab Sampler
August 02, 2022
Product Spotlight
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PerkinElmer’s GC 2400 Platform is designed to perform various sampling tasks related to gas chromatography and headspace sampling.
Automatic Vial Format Change System
August 02, 2022
Product Spotlight
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Telstar’s Smart Format system automatically transports vials of different formats.
Accurate Level Switches
August 02, 2022
Product Spotlight
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The Dynatrol G Series Level Switches are designed to accurately measure light or heavier bulk solids for problem applications.
Demerger and the Future
August 02, 2022
From The Editor
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GSK has completed its demerger of Haleon and has signed an agreement to help support future pandemic preparedness in Europe.
The Stick and Carrot of Quality Management
August 02, 2022
From the CEO
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How can we fix the quality manufacturing issues that come with product shortages?