Pharmaceutical Technology, May 2023

The use of smart tools in early drug discovery can have an impact on downstream phases of drug development.

Competition in the organ-on-a-chip market increases as NETRI enters the arena.

Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”

User fee programs have improved FDA’s approval timeline for important therapies.

Nanoparticles are becoming more prevalent to overcome low solubility and poor permeability.

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.

Process control is essential for using continuous hot-melt extrusion to enhance solubility.

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.

Strike action is impacting numerous sectors across Europe, including the bio/pharma industry.

Digital transformation to the Pharma 4.0 paradigm moves forward in process development and clinical and commercial manufacturing.

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.

The engine that drives pharmaceuticals forward, its workforce, is now very low on fuel.

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

A strategy on cyber resilience for health and social care organizations has been set out by the UK government.

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.

The ROSS Inline Ultra High Shear Sanitary Mixer Model HSM-715XSUHD-250 is designed to deliver exceptional dispersion, emulsification, and homogenization at high throughput.

Emerson’s Rosemount 319 Flushing Ring comes in both traditional and compact sizes.

Artisan Industries' Rototherm Mini is designed for continuous lab-scale operations.

Polyplus’ LipidBrick IM21.7 is designed to expand the scope of LNP usage in various therapeutic and oncology applications.

QMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.