Aldevron Breakthrough Blog: Client Experience

Evaluating Quality Systems with Your Manufacturing Partners

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!

Read More

Investments in Innovative Methods: Rapid Sterility Testing

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.

Read More

What to Consider When Using DIY Kits for Plasmid DNA Production

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.

Read More

Virtual Facility Audits Now Available

Challenging times require creative solutions. Especially now, when in-person contact is discouraged yet first-hand, observed information is critical, we all depend on fresh ways to think about how we provide access and insight.

Read More