On the Road to Ireland road trip campaign, Michael Howell, Site Director of Albumin Manufacturing at Grifols, speaks with Nigel Walker about how Grifols’ state-of-the-art facility in Dublin meets client demands in this new era in healthcare. Watch the full video or read the transcript below to learn about how risk assessment plays a major role in Grifols' success with customers.
For further information about the cutting-edge solutions that Grifols Partnership offers customers, read the print interview between Michael Howell and the Pharma's Almanac team, Innovating to Optimize Quality in Injectable Drugs.
Nigel Walker (NW): Good afternoon, everybody. My name is Nigel Walker from Pharma's Almanac. We have arrived here at Grifols, just outside of Dublin. As you can see, behind me is a brand new, beautiful facility in the final stages of validation. We’re going to be talking about the future of healthcare and how Michael Howell, Site Director of Albumin Manufacturing, and his team are going to make that happen.
Michael Howell (MH): So, healthcare as we know it today will no longer exist. The new needs of evolving technologies, more business models, the needs of customers to be closer to their products and understand more about their products is what’s coming at us.
The opportunity for Grifols is we continue to invest in these types of technologies. We look at optimizing processes. We look at new, state-of-the-art facilities, and probably more than ever, we continue to invest in the people that manage these facilities and understand these products.
NW: Grifols has a CDMO, which is part of the greater Grifols holding company. Can you talk to us about how Grifols is approaching the challenge of the CDMO?
MH: Grifols has been in the business of biopharmaceuticals for over 75 years. It’s that — I suppose — inherent knowledge and understanding of process in pharmaceuticals that has allowed us and encouraged us to go in to offer these types of solutions and know-how to potential customers and partners.
In 2004, we created the Grifols Partnership, which allowed us to offer these types of technologies and process understanding to partners and customers. We built our own site here in Dublin, Grifols Worldwide Operations. We receive products from Grifols Laboratories, such as water for injection and diluents, such as flexibags, which will be filled in our new state-of-the-art facility here in Dublin. This allows us to not only own and manage the entire supply chain, but also allows us to have full control over the quality of those supplies and offerings.
NW: Can you talk to us about some of the solutions that you’re providing today to your CDMO customers?
MH: Risk assessment and risk analysis of these key processes is very, very important. This allows us to understand the process, to understand the potential risks to that process. So, our technologies and our experience in that regard allow us then to truly understand the customer’s needs for their product. And we then build that into our state-of-the-art technologies, such as automation, recipe controls, etc., which protect the products and ultimately give the proper solution to our customers.
The follow-on from that is, what we do here at Grifols. We offer small molecule aseptic injectable filling. We can also supply solutions around diluted and concentrated products in that realm.
NW: This is a major investment. I’m guessing multiple hundreds of millions of dollars.
MH: Approaching probably over 200 million dollars. We’ve built up our packaging portfolio initially around one million doses per year. We’re up now at nine million. A further nine million coming at us next year, so growing to 16 million doses. Then obviously the new biologics plant is kicking off in 2023.
NW: So, you’re going to have some heavy capacity here.
MH: Yes, massive. All of the fractionation will be done at our facilities in North Carolina and Spain, but the purification here and the scale that we’re doing it at is huge.
NW: There are many challenges with injectable product manufacturing. Can you talk to us about some of those challenges and how Grifols is overcoming them?
MH: When you’re dealing with a facility like this, your greatest risk of contamination actually comes from people. Grifols, over the years, have evolved their technologies, first and foremost in the design of their facilities, making sure that their cleanroom standards are up to 2022 and 2023 standards. And then also from an automation and engineering principles point of view.
Automation today allows us to use robots in a way that wasn’t capable 20 years ago. That now allows us to place robots where humans used to interface with product. We’ve removed humans from that point and that allows us to reduce the risk and obviously make better-quality products for our customers and ultimately support the patient in that regard.
NW: A really interesting topic here is that when we started out in the CDMO business — it wasn’t called “CDMO,” it was called “outsourcing," and it was over 27 years ago — the CDMOs were quite small. And now we’re actually seeing that there are a number of CDMOs that are much larger than the biotechs themselves.
MH: Exactly. Just like ourselves, because we’re quite a larger company with our own resources, we’re able to tap into our own regulatory, financial, technical groups within the Grifols network and support our customers and our contract manufacturing partners in that regard.
It’s not just an investment in infrastructure, such as the state-of-the-art facility we have here and the technology and automation that goes with it, but also in its people. It puts information at our fingertips, which allows us to make better decisions for our products, ultimately giving the customer exactly what they need from a quality of product point of view, and obviously serving our patients first.
NW: Well, I think it’s time for us to all go outside and take a look at the DeLorean. We’ve had a delightful few hours here with Michael and the team from Grifols here just outside of central Dublin. Thank you.
To learn more about the cutting-edge solutions that Grifols Partnership offers customers, read the formal interview between Michael Howell and the Pharma's Almanac team, Innovating to Optimize Quality in Injectable Drugs.
