Biobetter Development
Weighing development costs/resources and performance benefits is essential.
Taking Stock of a Maturing CGT Sector
As the CGT market matures, increased focus lays in securing optimal efficacy while ensuring safety.
QRM, Knowledge Management, and the Importance of ICH Q9(R1)
This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment.
The Rising Iceberg of Lyophilized Innovations
The increased demand for biopharmaceutical products is increasing the demand for lyophilization innovations and services.
Advancing Analytical Testing Techniques
Although advancements in analytical drug substance testing are being made, the increasing diversity of the therapeutic landscape is necessitating further innovation.
The Importance of HCP Monitoring
HCPs are major process-related impurities that must be monitored throughout biologics production for clearance.
Publisher's Note: With Age Comes Wisdom
A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.
Post-Warning Letter Interaction with FDA
Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.
Flexible Inline High Shear Mixer with Built-in Workbench
The ROSS Model HSM-405SC-25 Inline High Shear Mixer features a built-in workbench and is designed for production floors that require flexibility.
CO2 Incubators
The VIOS family of incubators are known for optimal cell growth conditions and minimal contamination risk.
