Tom Lynch, Vice President of Sales & Client Development at Aldevron joined us at TIDES US in San Diego to discuss the company's role as a CDMO and how it is approaching the oligonucleotides market as a critical raw materials supplier.
Could you tell us about Aldevron?
Sure. We’re a CDMO. We’re celebrating our 21st year in business this year. We operate at three locations: our headquarters is based in Fargo, North Dakota; we also have facilities in Madison, Wisconsin as well as Freiburg, Germany.
We are producing biologics across four platforms: plasma DNA, messenger RNA, proteins and antibodies, and we’re also producing these materials across three different quality levels: research use only as well as up to cGMP, and also over the last several years have created a quality level called GMP source. It’s a very popular quality system for our clients and partners who are in early clinical work. This gives us an opportunity to manufacture biologics that have all the hallmarks of GMP, but we can do it at a lower price as well as a reduced timeline compared to GMP.
As a CDMO, what do you see as your most important activities?
First and foremost is clear communication with our clients and partners, before, during and after a program for when we’re manufacturing biologics. The second is to execute scientifically. This is how we build trust with our clients and our partners, making sure we understand the biology, we execute and we deliver the material.
This gets us to my third point which is on-time delivery to the specifications that our clients require, making sure that we’re meeting timelines in order for them to keep their program timelines on pace. And then, throughout it all, is innovation. We need to make sure that we’re continuously working to improve our processes as well as our efficiencies to help drive down costs as well as timelines.
And why is it so important to be here at TIDES?
This is our first year participating in the event. We’re very excited to be here. There’s been a lot of demand for high quality nucleotides in support of cell and gene therapies and immunotherapies and so, with our plasma DNA and our newly-created messenger RNA platforms, we want to be able to have an opportunity to connect with researchers and allow them to get in sync with our program where we’re offering the manufacture of these biologics using similar processes, from research-use all the way through clinical and commercial applications.
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Treatment of genetic diseases has expanded (some may say exploded), and the use of oligonucleotides has helped with the development of these cures. As a supplier how does Aldevron see itself fitting into that development and commercialization process?
Our tagline says it best: we are the basis for breakthroughs - and what that means is we are very proud to be manufacturers and producers of the critical raw materials that are typically the first step in a process of a manufacture of a cell or gene therapy and so we take this responsibility very seriously. And we want to make sure that we’re working with our clients and our partners throughout their development, their clinical processes.
And how does Aldevron ensure it understands the goals of developing these cures?
I mean, this why we’re here. We make sure that we attend scientific conferences and meetings, we participate in those, we also make it a point to get in front of academic researchers, commercial industrial scientists, [and] make sure we get a good understanding of where they need to take their development programs to ensure that we can help meet their goals.
What’s new at Aldevron and what can we expect in the future?
There’s a lot going on at Aldevron. It's a very exciting time, not only in the industry but also in our organisation. We have a lot of expansion. We’re expanding across our three locations, expanding the footprint as well as our services and products. A key notable products and services expansion is our messenger RNA program. We’ve been making IVT enzymes for many years, we've also produced plenty of linearized plasma DNA for our clients, and now we’ve combined those two to produce a one-stop program for our clients who need messenger RNA.
We’re also expanding into the support of neoantigen workflows which require very compressed and short timelines for the manufacture of high quality biologics, and we're also producing research-use and clinical off-the-shelf options, not only for plasma DNA sets in support of AAV and lentiviral production, but also for off-the-shelf CAS-9 nucleases in support of genome-editing.
So that expansion, the expansion of the product and catalogues and also the expansion of my team. At the very end of the day, we want to make sure that our clients have the best experience possible, that we meet their timelines, we’re producing the high quality biologics and throughout we have a good collaborative feel and flow to the manufacturing timelines.
So a busy time ahead!
Very busy time ahead, and we see continuing growth in this area and we’re planning accordingly to make sure that we meet the demand and drive down the timelines to produce this material, because at the end of the day, we understand that getting breakthroughs into the clinic is very important.
Tom Lynch was interviewed for TIDES TV at TIDES US in San Diego, CA, May 20-23, 2019.
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