Building The Digital CDMO with TetraScience
As Vice President of Digital and Technology Solutions at Andelyn Biosciences, Bryan Holmes is responsible for all aspects of Andelyn’s digital ecosystem, focusing on Information Security, Infrastructure, the Connected Plant, and Business Systems. In this blog, Bryan shares how Andelyn’s deep partnership with TetraScience is propelling his dream of creating The Digital CDMO into reality.
Why did you join Andelyn?
Andelyn provided a unique opportunity to build out a technology vision for an organization that is on the forefront of gene therapy treatments and do this while building a brand-new, state-of-the-art facility in Columbus, OH. It is rare to get an opportunity to define a full strategy for a greenfield organization without legacy technical debt, but this is what was presented to me. I loved the culture and background of the company and knew this was a place that I could both continue to grow personally and professionally, but also contribute a great deal to the organization. Now we are enroute to building “THE Digital CDMO” with a great team and digital fluency growing across the whole organization!
It is rare to get an opportunity to define a full strategy for a greenfield organization without legacy technical debt, but this is what was presented to me.
In a sentence or two, what does Andelyn Biosciences do?
We help our clients, whether small biotech, large pharma, or hospital researchers, take their ideas for advanced therapies through the development lifecycle, ultimately providing the ability to make commercial grade batches in our GMP facilities. In addition to the products we make, we are also, in reality, a Scientific Data Company too – as earlier stage products are all about the data generated to maximize safety and potency while minimizing toxicity during drug development.
Why was the name Andelyn Biosciences chosen?
This is a great story. Nationwide Children’s Hospital (NCH) has been at the forefront of Gene Therapy for several decades, with some of the top pioneers in the industry having performed research at the hospital. Andelyn is a standalone organization that has been spun out from NCH and when choosing a name for the company it was chosen as a combination of the names of the first two patients to receive Gene Therapy treatments at NCH- Andrew and Evelyn. This really ties back to why we do this as an industry - to improve and save lives.
Andelyn recently completed GMP validation of its platform. Why is this so important, so significant?
As I mentioned, one of the main reasons why I chose to join Andelyn was the ability to set the strategic vision for our Digital and Technology stack. The key aspect to doing this became rooted in our guiding principles. We wanted to be “Born in the Cloud”, “Design with Security in Mind” and treat “Data as an Asset” to name a few.
Andelyn has compliance requirements focused on data integrity – and that doesn’t mean that data goes into an archive to die. It’s quite the opposite.
The “Data as an Asset” is a guidepost for us in building out THE Digital CDMO. One of the biggest challenges the industry faces is having disconnected data and then struggling to correlate data from manufacturing processes to lab test results. Andelyn has compliance requirements focused on data integrity – and that doesn’t mean that data goes into an archive to die. It’s quite the opposite. We have a good chain of custody of our electronic assets to ensure that we put the pieces of the puzzle together in valuable ways that were previously not possible. So much work has led up to us being able to get this platform validated and ready to ingest all our data going forward. TetraScience is the core platform for our scientific data and a real differentiator and accelerator to our business.
What types of milestones preceded the GMP validation?
The “Design with Security in Mind” guiding principle comes to mind. Connecting shop floor equipment and lab instruments to the network itself is something that brings about either a security risk or a compliance risk – and neither of these can be tolerated! Our first milestones were to ensure that the infrastructure and network would be designed with a zero trust approach with the correct layers of security controls to ensure that these special devices can be networked. From a compliance perspective, it’s also critical that these devices are viewed as special and don’t receive the same updates that a standard user device does, which could cause the validated state to be put in question.
Our first milestones was to ensure that the infrastructure and network would be designed with a zero trust approach with the correct layers of security controls to ensure that these special devices can be networked.
While we are in the process of building our new facility (including our new QC lab), we are still utilizing space in the hospital buildings that was designed for Andelyn. Until recently, we had also been leveraging NCH for all of our infrastructure and security setup. As the intent has been to be autonomous when moving into our new facility, we didn’t want to go too far down the path of connecting equipment on that network only to have to change later. We have recently completed the separation of many of these shared services, thus allowing us to proceed with connecting our devices.
Additionally, we had to define our validation processes and approach and build out an entire quality system. This is a high barrier entry type of business because these things take time. The requirements to do so go well beyond the definition and require pressure testing in both mock audits and real audits.
Another huge milestone was the opening of our Andelyn Development Center in Dublin, OH. This facility opened in April of this year, with our Analytical Development, Process Development and Pre-Clinical Manufacturing teams moving in along with all of their equipment in the months of April and May.
Why did you choose to work with TetraScience to achieve the goal of creating the Connected Plant?
It was love at first sight! Hahahaha. Honestly, we met with vendors across the entire IT ecosystem, hundreds of vendors, to define how to make the most of our greenfield opportunity. Over the course of several months, it became more and more clear that TetraScience was a company that we wanted to work with.
TetraScience has always had our ear for thoughts, suggestions, feedback, and ideas that will improve the platform, the user experience, and ultimately help us develop products faster for our clients.
The TetraScience solution matched perfectly with what we are trying to achieve. The missions of both companies align well, and TetraScience seemed easy to work with. We really benefit from and value the data and scientific expertise their dedicated team brings to us. It was also important to us to choose a partner that wasn’t set in their own ways, but also wanted to learn together with us. TetraScience has always had our ear for thoughts, suggestions, feedback, and ideas that will improve the platform, the user experience, and ultimately help us develop products faster for our clients.
Specifically, TetraScience provides outcomes that no other vendor can provide, and which are essential for our growth as the Digital CDMO:
What value does the Tetra Partner Network (TPN) bring to you?
When looking at a Connected Plant strategy, we have to evaluate what can be achieved natively and how much has to be custom built over time. The Tetra Partner Network (TPN) is essential and foundational to the value of TetraScience’s Scientific Data Cloud offering. TPN is a key reason we chose to work with TetraScience. We rely on TPN not only to deliver pre-built connectors, but also to connect us to their partners, who are as committed to unrestricted data innovation as we are.
TPN is a key reason we chose to work with TetraScience. We rely on TPN not only to deliver pre-built connectors, but also to connect us to their partners, who are as committed to unrestricted data innovation as we are.
If a company is a member of TPN, we shortlist them during our evaluation process. If TPN has a relationship already, it gives that vendor a head start for us. It doesn’t mean we will go exclusively that route, but it’s a great value-add option for us when we start looking at the procurement component as well. One example where we made a key decision anchored to our strategy with TetraScience and the Tetra Partner Network is with our decision to implement LabVantage LIMS for our QC laboratories. We chose LabVantage because they were willing to work with TetraScience and the Tetra Partner Network
Who are your customers and why do they choose to work with Andelyn?
We have a wide range of customers, ranging from small Biotech to traditional large Pharma companies as well as principal investigators at different research institutes. One of the common themes that comes out in feedback from customers is our attention to quality, technical expertise, and collaborative nature. We are really trying to change the C in CDMO from being “Contract” and transactional oriented into “Collaborative”.
We are really trying to change the C in CDMO from being “Contract” and transactional oriented into “Collaborative”.
Where will the Connected Plant take the industry?
I really think we are on to something big here. The approach to productize our data along with our physical product will enable better insights into the data. This can help correlate data that has never been able to be looked at together so easily and ultimately a strong data foundation will allow for the advanced technologies like AI & ML to be incorporated into the development process.
I would love to see our customers adopt our data platforms and integrate CRO data and any other data on their end to have full visibility and ability to analyze across an entire product.
I would love to see the industry move away from traditional siloes of R&D, Tech Transfer & Operations to a product focus across the spectrum. I would love to see our customers adopt our data platforms and integrate CRO data and any other data on their end to have full visibility and ability to analyze across an entire product.
Is there anything else you’d like to share?
The Gene Therapy industry is a challenging one. There are so many rare diseases that have no treatments available in the current marketplace. The high cost of bringing treatments to market is widely known. If we, as an industry, are able to start leveraging our data assets early in this process, to both predict successful study outcomes as well as to predict those are going to be unsuccessful, we can hopefully reduce these costs and challenges as well as the time it takes to bring products to market. Speaking of bringing products to market, we have lots of exciting developments with our facilities:
- The new Andelyn Development Center, a 50,000 square-foot state-of-the-art preclinical, process development, and analytical development facility supporting research and pre-clinical manufacturing, opened in April 2022 in Dublin Ohio.
- The phased opening of our 200,000 square-foot Commercial Headquarters and Manufacturing Facility in Columbus Ohio is slated to begin in August 2022 -- a full five months ahead of schedule, with the full facility completed in early 2023.
- The Andelyn Plasmid Center opens soon in Q3 2022 to provide increasing capacity of phase appropriate plasmids from research grade to cGMP all using single use consumables ensuring the highest quality.
And The Rev is the man!