Janet Woodcock’s recent comment on the state of pharmaceutical development, “It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?
By Bikash Chatterjee, president and chief science officer, Pharmatech Associates
The FDA's Knowledge-aided Assessment & Structured Application framework (KASA) marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed.
Application Note |
By Svea Grieb, Johannes Lemke, Markus Schulze, and Jens Matuszczyk,Sartorius Stedim Biotech
Intensified processing represents a major trend in the biopharma industry because it increases the productivity of Single-Use (SU) facilities, while decreasing the manufacturing footprint. Here's how to optimize the approach.
Rethinking aseptic filling from technology to process to service while meeting shifting market demands will help all participants in the pharmaceutical industry, and, ultimately, help the smaller patient populations who need targeted therapies.
Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.
Given the rapidly changing landscape of today's trials, if sponsors wish to succeed, they must remain vigilant — attending to every detail of the process. Learn how several sponsors achieved success through these case study examples.
Upon assessment of their paper-based SOP delivery system, facility leaders at Biogen's Cambridge manufacturing plant found their procedures inefficient and costly. Find out how much the company saved by choosing a digital platform.
Single-use technology (SUT) has transformed biopharmaceutical development and manufacturing. While the benefits of SUT in bioprocessing are clear, the pathways to successfully applying SUT continue to rapidly evolve.