mRNA innovation is one of the most exciting and impactful areas of healthcare globally today.
A process that has increasingly expansive application potential in treating diseases or functioning as a vaccine, mRNA instructs cells in the body to make key proteins that play an essential role in our bodies.
Sitting down with Guido Seidel, Managing Director of Wacker Biotech, we explore some of the key challenges and opportunities for pharmaceutical companies in this field in 2024.
Highlighting several challenges associated with the stability of molecules, scalability of processes and the robustness and quality of products required to reach production, Seidel lists several of the key ingredients that need to be considered in order to ensure mRNA success.
“You have to have a good understanding of critical process parameters,” he explains, highlighting this as vital to scaling up smaller processes without compromising product quality.
Wacker Biotech is a company with significant expertise in this domain, focusing on different aspects of the mRNA supply chain across its facilities in Germany, the Netherlands and the U.S. Indeed, the organization continues to play a key role in innovating processes and solutions within the field of mRNA.
“The processes for mRNA we have seen some years before will not be the processes which we will see in two years from now, and our facility is ready to already cope with these new processes,” Seidel affirms.
To find out more about cutting-edge mRNA innovation, Wacker Biotech’s contributions from its innovation center and R&D labs, and the criticality of kickstarting collaboration among stakeholders across the value chain, watch the full interview.
Visit Wacker Biotech to learn more.
Michelle Benz:
Hello everyone and welcome back. Thank you for joining me today. My name is Michelle Benz, content director here at Fierce. Joining me we have Guido Seidel, Managing Director of Wacker Biotech. Thank you for joining me today.
Guido Seidel:
You're welcome and happy to be here.
Michelle Benz:
All right, so my first question, Wacker Biotech is engaged in the process of mRNA technology. What are the challenges that you see pharma companies facing in this field?
Guido Seidel:
So in principle, pharmaceutical companies face a lot of challenges, of course, in this new technology field of mRNA production. As we are a CMC partner, a contract development and manufacturing organization, I would like to focus on the manufacturing challenges. And this is, of course, the stability of the molecule, the scalability of the process, and also the robustness and the quality which we need to deliver at the end of a production. So, this all means you have to have a good understanding of critical process parameters and what is challenging the production is that with these new molecules, there is no large scale industrial process. So basically, you're coming from lab scale processes, and you have to scale them up and you need to have a lot of know-how to scale this up. And this is something we are offering to the pharmaceutical companies, helping them to develop and to scale a process in a manner that it can be produced in large scales, in industrial scales, but also with high quality, which is needed for patient and to clinical studies later on.
Michelle Benz:
And how is Wacker addressing these challenges?
Guido Seidel:
Yeah, we have a network of different sites. We have sites in Germany, we have a site in Amsterdam in the Netherlands, and we have a site in San Diego. And we are producing on the different sites, different, I would say, parts of the supply chain for mRNA production. We have plasmid DNA production in San Diego, we have mRNA production with solvents in Amsterdam, and we have a large facility coming on stream in April 2024, which is based on all other kinds of mRNA processes. So, we can do small scale productions there, we can do large scale productions there. In different setups, very flexible process setup, and to really look also on the processes for the future because the processes for mRNA we have seen some years before will not be the processes which we will see in two years from now. And our facility is ready cope with these new processes. So, this is how we address these challenges offering innovative platform solutions, innovative manufacturing solutions where our clients, mainly pharmaceutical companies, can work in.
Michelle Benz:
That's so exciting. And I know you mentioned facilities, so the mRNA Competence Center in Halle is your new flexible large scale production facility. You mentioned innovation as well. So what about the innovation part in Wacker solutions?
Guido Seidel:
So, the innovation is basically based in our R&D center and in our process development labs. We have developed our own proprietary processes which we can offer to our clients for the production of mRNA.
The mRNA field is, there are a lot of intellectual property around, and I think to navigate through this intellectual property is one of the core competencies which we can offer. There we are really innovating in terms of processes and analyzers for all the molecules. It goes from the plasmid DNA over the mRNA, but also in the field of, I would say, lipid nanoparticles, so the formulation of the mRNA later on. We have developed own competencies and also in the direction of having own patents so this is something we can offer to our clients.
Michelle Benz:
That's exciting. So, for our viewers watching and that are interested in mRNA manufacturing and your solutions, how do they enter a dialogue or perhaps start a collaboration with Wacker?
Guido Seidel:
So in principle, we are very active on conferences and also joining a lot of the big conferences like the mRNA leaders or also the BIO, advanced therapy conferences. So, you can join us in person there, but you can also, I would say, just visit our webpage so you can Google for Wacker Biotech and mRNA. You find us very easily. You can reach by email to [email protected] would be the email address, or we are very active on LinkedIn. You can drop myself a note directly or also look for other employees of Wacker Biotech. We are very connected to the outer world and using all the channels which are there.
Michelle Benz:
That sounds great. Thank you so much for taking the time today.
Guido Seidel:
Happy to do so.