Pharmaceutical Technology, July 2024

Weighing development costs/resources and performance benefits is essential.

As the CGT market matures, increased focus lays in securing optimal efficacy while ensuring safety.

This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment.

The increased demand for biopharmaceutical products is increasing the demand for lyophilization innovations and services.

Although advancements in analytical drug substance testing are being made, the increasing diversity of the therapeutic landscape is necessitating further innovation.

HCPs are major process-related impurities that must be monitored throughout biologics production for clearance.

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.

The ROSS Model HSM-405SC-25 Inline High Shear Mixer features a built-in workbench and is designed for production floors that require flexibility.

The VIOS family of incubators are known for optimal cell growth conditions and minimal contamination risk.