From the early days of therapeutics development, a common refrain has been that GMP manufacturing takes longer and costs more than expected. This can be traced back to when programs often started in academic laboratories, which then needed substantial analytical and process development as a program moved towards clinical stages.
Move fast. Limited funds. Novel ideas. These are consistent themes I’ve noticed in conversations with hundreds of biotechs over the last 20 years, and rightly so. However, these elements sometimes overshadow the need to evaluate the complexities and costs associated with GMP manufacturing in support of a clinical trial, along with what’s needed for manufacturing at phase III and beyond.
Cell and gene therapies (C>s) comprise a rapidly expanding segment of the life science industry. Due to this growth, companies can encounter significant challenges when scaling their therapeutics from research through clinical trials to commercialization.
The C> industry is working to standardize manufacturing processes and practices, and here at Aldevron we have joined forces with multiple industry consortia to help address these challenges.
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.
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.
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.
