AIRMIX – A Softer, Gentler Lysis

Arguably, the most challenging step in plasmid manufacturing is cell lysis. Thousands of times larger than a typical small molecule pharmaceutical API, a plasmid is a large circular molecule that most of our clients prefer in the supercoiled form. Several things can go wrong if the lysis step is too harsh. First, the plasmid molecule will […]

Minimizing Cleaning Validation

One of the major challenges of plasmid manufacturing is cleaning validation. To avoid excess costs and time, disposable technology can decrease validation needs for both the cleaning and sterilization processes of fixed equipment systems. Disposable materials for use inpharmaceutical manufacturinghave come a long way fromtraditional reusable technology.From pipettes and syringes todisposable bioreactors and pre-packed purification […]

From Dreadful to Enjoyable: Transform Your cGMP Training

Most companies struggle with  how to make cGMP training more fun and exciting. As the Quality Assurance director of a company that provides contract plasmid manufacturing, it seems almost impossible for me to find time to be creative. This year for the “dreaded” cGMP training we played a game – yes, a game – called […]