Investing for the Future: Quality cGMP Cell Banks

Cell banking is essential for a biological product manufactured by the fermentation process, such as plasmid DNA. Particular emphasis is given to cGMP cell banks by following the regulatory standards (21CFR610). But how do you generate high quality cGMP cell banks, and what are considered important attributes? Guidelines do not tell us. First, let’s look at […]

Helpful cGMP Tips for the QA Manager

As a QA Manager for a plasmid manufacturer, I am always looking for innovative ways to maintain a focus on cGMP and help employees understand its importance. cGMP training accomplishes this, but it only occurs once or twice a year in most organizations. If you do not have a dedicated training department, it most likely only […]

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 […]