Aldevron Breakthrough Blog: Clinical Grade Manufacturing/cGMP

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!

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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.

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Advanced HVAC - The Cornerstone of Aldevron Cleanrooms

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. 

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Advancing Therapies with mRNA

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.

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