A common question we receive from clients is how to evaluate a new manufacturer's quality system, and how to verify that it complies with global regulatory bodies' prescribed guidance, especially since the landscape surrounding regulatory guidance is constantly changing as the cell and gene therapy industry evolves.
Luckily, I was fortunate enough to sit down with Ken Bonnell, Aldevron’s Senior Vice President of Quality and Regulatory Affairs, to learn more about how to evaluate manufacturing partners, what to look for, and what is important. You can continue to read our conversation in this article or listen by checking out the video below!
Speed, control and comparable results: these are among the foremost needs of contract development and manufacturing organizations (CDMOs) and our clients when it comes to plasmid DNA that will be used to support cell and gene therapy at a research, clinical and commercial level. As an early adopter of rapid sterility testing, Aldevron delivers on all three.
Plasmid DNA purification has come a long way since Herbert Boyer and Stanley N. Cohen's experiments in the early 1970s. Molecular biology is now dominated by the various ways recombinant DNA and RNA can be manipulated, and purification techniques have evolved to meet this demand. In sharp contrast to the complicated, labor-intensive efforts that were needed in previous decades to extract even a small amount of DNA, there are now numerous easy-to-use DIY kits available that enable researchers to obtain the DNA they need.
At the turn of the century, viral manufacturers were facing major headwinds, and the sector was in a rut. Part of the problem was the inability to get enough clinical grade DNA, quickly enough, at the right price point for them to be able to progress through clinical trials.