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Pharmaceutical Technology, May 2023
Using Smart Tools for Smart Development
May 03, 2023
Cover Story
47
5
The use of smart tools in early drug discovery can have an impact on downstream phases of drug development.
Frontrunner in Organ-on-a-Chip
May 03, 2023
European Frontrunners
47
5
Competition in the organ-on-a-chip market increases as NETRI enters the arena.
Quality Quartets in Risk-Based Qualification
May 02, 2023
Quality/Regulations
47
5
Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”
High-Quality Communication Enables High-Quality Drug Products
May 02, 2023
Quality/Regulations
47
5
User fee programs have improved FDA’s approval timeline for important therapies.
The Next Challenge in Dissolution–Nanoparticles
May 02, 2023
Analytics
47
5
Nanoparticles are becoming more prevalent to overcome low solubility and poor permeability.
Optimizing the Manufacture of Emerging Therapies
May 02, 2023
Quality/Regulations
47
5
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
Continuous Hot-Melt Extrusion for Poorly Soluble APIs
May 02, 2023
Development
47
5
Process control is essential for using continuous hot-melt extrusion to enhance solubility.
Springing Forward
May 02, 2023
From The Editor
47
5
INTERPHEX was back in full swing with Keynote sessions highlighting cutting-edge technologies that are setting the stage for the bio/pharma industry’s future.
On Strike!
May 02, 2023
From The Editor
47
5
Strike action is impacting numerous sectors across Europe, including the bio/pharma industry.
Envisioning Digital Pharma Manufacturing
May 02, 2023
Manufacturing
47
5
Digital transformation to the Pharma 4.0 paradigm moves forward in process development and clinical and commercial manufacturing.
Measuring Quality in a Culture
May 02, 2023
Ask the Expert
47
5
The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.
Young Pups and Leopards
May 02, 2023
From the CEO
47
5
The engine that drives pharmaceuticals forward, its workforce, is now very low on fuel.
FDA and Industry Prepare for End to COVID-19 Emergency
May 02, 2023
Regulatory Watch
47
5
FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
Protecting the NHS from Cyber Attacks
May 02, 2023
Regulatory Watch
47
5
A strategy on cyber resilience for health and social care organizations has been set out by the UK government.
Total Analytical Error in Validation of Analytical Procedures of Pharmaceuticals
May 02, 2023
Peer Reviewed
47
5
This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors.
ROSS Inline Ultra High Shear Mixer for High Quality Dispersions and Emulsions
May 02, 2023
Product Spotlight
47
5
The ROSS Inline Ultra High Shear Sanitary Mixer Model HSM-715XSUHD-250 is designed to deliver exceptional dispersion, emulsification, and homogenization at high throughput.
Dual Flushing Rings
May 02, 2023
Product Spotlight
47
5
Emerson’s Rosemount 319 Flushing Ring comes in both traditional and compact sizes.
Lab-Scale Evaporator and Dryer
May 02, 2023
Product Spotlight
47
5
Artisan Industries' Rototherm Mini is designed for continuous lab-scale operations.
LNP Formulation for mRNA Therapies
May 02, 2023
Product Spotlight
47
5
Polyplus’ LipidBrick IM21.7 is designed to expand the scope of LNP usage in various therapeutic and oncology applications.
QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract Manufacturers
May 02, 2023
Quality/Regulations
47
5
QMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.