Ensuring Aseptic Technique: Use of Isolators

Ensuring Aseptic Technique: Use of Isolators

By: Deb Quick, Ph.D. Senior Consultant Everyone knows that good aseptic technique is crucial when handling biological products, particularly in fill and finish operations. But for cellular therapies, good aseptic technique is essential throughout the entire process to...

What is a process control strategy and why is it important?

By Maria Wik, MS VP, CMC Development The ICH Q10 definition for a Control Strategy is: “A planned set of controls, derived from current product and process understanding, that assures process performance and product quality.” Understanding the essence of a process...
Three Characteristics of a Rock Star QC Partner

Three Characteristics of a Rock Star QC Partner

Biomedical startups experience a failure rate of 90% per year for various reasons, including flawed financial strategies, inexperienced management, subpar science, poor timing, and an aversion to risk. Another significant factor is quality control issues stemming from...
3 Critical Keys to Expediting CMC Development

3 Critical Keys to Expediting CMC Development

Certain key strategies are imperative for establishing effective quality control (QC) systems in the development of new pharmaceuticals. The “Key 3” are implementing a QC process control strategy, creating a Standard Operating Procedure (SOP) manual, and partnering...