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Pharmaceutical Technology, June 2022
Automating Aseptic Processing Reduces Contamination Risk
June 03, 2022
Manufacturing
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6
Industry experts discuss the need for stricter environmental controls, whether to incorporate single-use technologies, and areas for improved automation.
IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence
June 03, 2022
Peer-Reviewed Research
46
6
This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.
Focusing on the Patient in Drug Development
June 03, 2022
Development
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6
Putting the patient at the forefront of drug development is essential, particularly to ensure medication compliance is optimized.
Development of Coprocessed Excipients
June 03, 2022
Development
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6
The right processes used with the right excipient combinations address evolving formulation needs.
Early Development Challenges in IND Applications
June 03, 2022
Development
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6
Collecting relevant data, planning ahead, and communicating with regulatory bodies in pre-IND meeting programs can help companies to avoid roadblocks in IND applications.
Ensuring Patient Safety Through Elemental Impurity Analysis
June 02, 2022
Analytics
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6
Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.
When Is It Appropriate to Outsource Bioanalysis Work to a CRO?
June 02, 2022
Outsourcing
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6
When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.
Considerations for Cleaning Lipid Nanoparticles
June 02, 2022
Manufacturing
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6
This article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.
Connecting the Dots for Pharma
June 02, 2022
Exclusive coverage from PharmTech Europe
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6
The inaugural Connect in Pharma event will take place on 14 and 15 September in Geneva, Switzerland.
Enhanced Role of EMA in EU Crisis Response
June 02, 2022
Regulatory Watch
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6
EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.
An Unusual Threat: Pharma is Already Tackling the Monkeypox Outbreak
June 02, 2022
From The Editor
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6
Cases of monkeypox are rising around the world, but it is unlikely the virus will become a pandemic problem.
FDA to Continue Inspection Efficiencies After Pandemic
June 02, 2022
Regulatory Watch
46
6
FDA will use virtual site visits even after resuming active inspections.
Big Pharma in the Balance
June 02, 2022
Weighing Up Big Pharma
46
6
Is AI a panacea for pharma’s productivity gap?
Coming Together to Enable Cell and Gene Therapy Manufacturing
June 02, 2022
Manufacturing
46
6
Precompetitive consortiums seek solutions to industry-wide challenges.
Productive Client-CDMO Relationships
June 02, 2022
Ask the Expert
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6
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.
Reconditioned Mixers
June 02, 2022
Product Spotlight
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6
ROSS reconditioned DPM-40 Double Planetary Mixers offer comparable production to new mixers at a lower cost.
High-Plex Spatial Imaging System
June 02, 2022
Product Spotlight
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6
Standard BioTools’ Hyperion+ Imaging System can process more samples and has lower limits of detection than its predecessor.
High-Performance Coating Equipment Cleaner
June 02, 2022
Product Spotlight
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6
Colorcon’s OptiClenz delivers cGMP-validated high-performance coating equipment cleaning.
Precision Brushless Motor
June 02, 2022
Product Spotlight
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6
AMETEK Haydon Kerk Pittman’s 57mm size motor in its IDEA Motor series is designed for real-time, embedded motion control.
Is AI a Panacea for Pharma’s Productivity Gap?
June 02, 2022
From the CEO
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6
AI could provide solutions to critical manufacturing inefficiencies.