AI Meets Gene Therapy: AlignAI, Andelyn Biosciences collaborate to enable AI safely
Left to right: Bryan Homes (Andelyn), Rehgan Bleile (AlignAI), Nick Woo (AlignAI), Scott Brown (Andelyn) | Credit: Autumn Theodore Photography
Two Columbus-based technology leaders are teaming up to tackle one of the toughest challenges in BioTech: how to adopt artificial intelligence responsibly in a highly regulated, high-stakes manufacturing environment.
Andelyn Biosciences, a spin-out from Nationwide Children’s Hospital, specializes in contract development and manufacturing for gene therapies targeting rare diseases like spinal muscular atrophy (SMA). As a CDMO, Andelyn, which doesn’t develop its own products, works with hospitals, BioTechs, and foundations to scale research into reproducible manufacturing processes. That model comes with complex operational and regulatory requirements, especially when it comes to managing data.
“From a data security perspective, the products we make are our customers’ lifelines,” said Bryan Holmes, Vice President of Information Technology at Andelyn. “We’re essentially the bank for their intellectual property. We have to make sure that data is secure and that we’re not inadvertently exposing it to anyone else.”
That commitment to security and compliance has been put to the test as AI tools and vendors flood the market. Holmes recalled that nearly every industry conversation eventually touched on AI. “You can’t have a conversation without it,” he said. “We needed someone who could separate fact from fiction, someone with deep expertise who could help us figure out what’s real and what’s hype.”
That search led to AlignAI, a Columbus-based software startup focused on AI governance, adoption, and initiative management. The companies had collaborated before — AlignAI co-founder and CEO Rehgan Bleile led an executive session for Andelyn’s leadership team about 18 months ago — but the scope has now expanded into a comprehensive AI adoption strategy.
Building a Digital Foundation for AI
For Andelyn, AI adoption starts with data. The company’s manufacturing and lab environments generate massive volumes of operational and scientific data, much of it previously siloed or stored in paper-based records. “We’re talking about scientific data that needs to be synthesized and understood alongside operational opportunities for AI,” Bleile said. “Governance is extraordinarily important to their customers, to their legal team, and to their risk team.”
AlignAI’s role included setting up guidelines, policies, and standards for AI and ensuring the AI system designs are compliant with those guidelines to enable faster approvals to go live with those systems and drive adoption.
“It’s not just about identifying opportunities,” Bleile explained. “It’s about setting up the right guardrails, guidelines, and procedures so AI can be built responsibly and still move quickly.”
That approach is already accelerating the deployment of AI-enabled workflows. By improving data availability and establishing clear rules for what can and cannot be done with certain data, Andelyn has been able to reduce approval times from its risk teams which is a critical step in regulated environments.
Measuring Success Beyond KPIs
Both leaders emphasized that success isn’t just about hitting metrics. “We talk about value and success metrics all the time with our customers,” Bleile said. “Our objective is high adoption for high-value AI systems, deployed faster. In regulated environments, that’s challenging. Data quality, security, acceptable use, and workforce adoption all play a role.”
Holmes agreed, noting that cultural adoption is as important as technical deployment. “When people who aren’t the most tech-savvy start asking, ‘Could I do something like this?’, that’s when I know we’re making progress,” he said. “You start to see a shift toward tech-first, AI-first thinking.”
Backed by Fresh Funding
The partnership comes as AlignAI is poised for growth following a $1.6 million seed round led by Cleveland-based JumpStart Ventures, with participation from Rogue Women’s Fund, Bold Ventures, and local angel investors including Lisa Stein. The funding will help AlignAI continue building its intelligence engine, designed to help enterprises manage AI initiatives within risk and regulatory constraints.
“Our mission is to help customers move faster while staying in control,” Bleile said. “That’s especially critical in regulated industries, where the stakes are incredibly high.”
Looking Ahead
For Andelyn, the goal is to become a fully digital CDMO, with AI-enabled manufacturing as a competitive advantage in personalized medicine. For AlignAI, partnerships like this one are a proving ground for scaling responsible AI adoption in regulated industries.
“There’s a tremendous opportunity here,” Holmes said. “Life sciences is growing fast in Central Ohio, and having local expertise like AlignAI’s gives us a partner we can trust not just to help us adopt AI, but to help us do it the right way.”