Pharmaceutical Technology, April 2024

With an ever-growing market driving technological advances, there is always work to be done in drug manufacturing.

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Advanced oral dosage forms allow for modulation of controlled- and sustained-release profiles.

Packaging and packaging line innovations are addressing the industry’s growing use of biologics.

What are the lessons gleaned from a product’s E&L lifetime?

Plans to update the European Union’s variation framework have been finalized.

There are considerations companies may want to consider before seeking out a service provider.

The European pharma industry needs to be prepared for the new clinical data requirements.

A revised regulatory variation framework should make lifecycle management more efficient in Europe.

Experts believe it is likely cancer cells are more common in the body than previously thought, but typically caught early and removed in the body’s cancer-immune cycle. When the system is in good working order (and protecting us), dead cancer cells release neoantigens.

Compliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

The ROSS line of Dual Shaft Mixers are robust, versatile systems with enough power to batch dispersions, suspensions, and emulsions with viscosities up to several hundred thousand centipoise.

The SD-5 is the sixth custom spray dryer in operation at Serán, which aims to achieve high yields with batch sizes <50 mg of APIs.

Univar Solution’s Grace Syloid FP and XDP Silica is a multifunctional excipient designed to solve powder flow and caking challenges in various pharmaceutical applications.

Emerson’s Fisher FIELDVUE DVC7K Digital Valve Controller provides local analysis of valve data and digital communications with host systems, as well as other features.