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!

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.

Aldevron has taken the basic design of heating, ventilation, and air conditioning systems (HVAC) for biological manufacturing clean rooms a step beyond the industry standard. The result is a super-clean system in our primary facility that allows us to produce the highest quality plasmid DNA, proteins and enzymes. In fact, from a cleanliness standpoint the Aldevron HVAC system is the cleanest I’ve worked on in my 20 years in the industry. 

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.

Plasmids are essential for the development of viral vectors used to manufacture novel gene therapies and viral vaccines. Aldevron is supporting the innovation of drug developers in this space by providing standardized royalty-free, bulk AAV helper and lentiviral packaging plasmids for research and GMP production.

Spring brought nearly perfect conditions to the job site. The fortunate lack of rain, snow, and extreme temperatures allowed the campus buildout to buzz with contractors, laborers and equipment.

The idea of using messenger RNA (mRNA) as a drug or vaccine has interested scientists for decades. It transiently passes genetic information to the protein factories inside our cells, and can be engineered to tell this machinery what to make to fight, or prevent, disease.

Demand for CMO fermentation capacity has exploded in the past couple of years, and it’s become very important that we find new ways to meet industry demand. That’s a big reason we’re seeing single-use fermentation (SUF) technology as an accelerating trend in the industry, especially for us at Aldevron.