Nate Spangler, Ph.D., Director of Innovation & Strategy at Aldevron discusses the challenges of manufacturing mRNA under the increased demand and helpful strategies to solve them.
Nate was interviewed by Michael Dunnet for TIDES TV.
Justin Byers, Client Relations Senior Manager, GMP Custom Protein Services at Aldevron discusses important considerations for achieving GMP quality protein manufacturing for advanced therapeutics and vaccines.
He was interviewed by Michael Dunnet for TIDES TV.
Aldevron has offered off-the-shelf GMP protein products since 2017, but our customers are often surprised to discover that we can also manufacture custom GMP proteins.
Aldevron recently hosted a webinar through Endpoints news titled: Plasmid DNA Insights: Expanded Focus on CMC in Gene and Cell Therapy Development.
Arsalan Arif, the publisher and founder of Endpoints News moderated the well-balanced, industry expert guest panel featuring Dr. Anthony Davis, Chief Executive of Dark Horse Consulting, Ken Bonnell, SVP of Quality and Regulatory at Aldevron; Biswarup Dasgupta, Director of Quality Assurance at Sarepta; and Frank Bonnelly, Director of Supply Chain at Encoded.
Our inaugural presentation for the Breakthrough Speaker Series is Dr. Laurence Cooper, on behalf of ZioPharm Oncology, presenting "DNA Plasmids for the Genetic Engineering of Clinical-Grade T cells".
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.
