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!
What advice do you have for newcomers to cell and gene therapy?
I have had the advantage of working in medical device manufacturing, biotechnology and pharmaceuticals – they are very different, but medical device manufacturing and pharmaceutical manufacturing are a lot more related than biotechnology.
The reason for this is the agencies are still learning how to regulate this as we go. This is because there are new developments every day in biotechnology, whereas you think about a pharmaceutical company, there are hundreds and thousands of drugs on the market already.
Even when you get approval for a drug that goes generic, there's not a major modification of molecular structure, but when you talk about biotechnology, it's a little bit of art and a little bit of science. All agencies are learning in real time. They ask what is important, what is not important, what to regulate, what not to regulate, when to be very prescriptive, and when to back off a little bit.
My advice is to first understand that it [biotechnology regulation] is different. The second is to understand that this is a changing environment. You must keep up with what direction the industry is going.
What areas of a quality system should be looked at the most?
I have been on both sides of the table, so I have the foresight of understanding what they will look for. The first thing that they will ask foreign customers, as well as any regulatory authority, is deviations and investigations. I once had an FDA auditor tell me this directly, and he said that we had many problems out on the floor that we had not actually discovered at that time.
When it comes to deviation and investigation, this is something that you already know about, so the way you handle it is reflective of your culture – it is reflective of your understanding of quality, and it is not just the investigation itself.
When you do an investigation, you would make sure you identify the root cause, and you pursue good corrective and preventative actions. After you install those CAPAs, in terms of actions you want to make sure they are effective. The way you make sure they are effective is that you never see those problems reoccur.
Again, if I am sitting on the other side of the table, I want to see the number of investigations, I would like to read a few of them, and I want to understand your ratio in terms of re-occurrence.
What should a Quality Inspector look for?
First, I would look at your quality systems in terms of their infrastructure. I want to make sure that they have SOPs to support all the critical activities.
The second thing I would do is talk with some of their personnel, because you get more information from interacting with them than anything. If you ask them questions about their process and if you already read the SOPs, then they should understand what the “recipes” say. If they do not, they should have them printed out there, following them step by step.
The third thing is obviously about the facility – if the facility is well maintained or not. Again, that is reflective of the quality culture.
What should a client look for when auditing a vendor?
Simple. Three things: people, process and procedure. At Aldevron, we have all three. Therefore I think that customers would select us as a partner because we are in it with them. This is a journey that we take together. We believe in true partnerships from not just a quality perspective, but from operations and customer relations – from every perspective.