Well-funded startup ElevateBio looks to attain critical manufacturing mass

When ElevateBio was founded in 2017, the startup’s vision was to help advance the cell and gene therapy industry by accelerating the discovery, development, and manufacturing of therapeutic approaches and modalities. Now, more than eight years later and after raising $1.3 billion in total capital, the Waltham, Massachusetts-based genetic medicines company appears to be reaching critical mass.

ElevateBio is built around two focus areas: BaseCamp, its end-to-end genetic medicine process development and cGMP manufacturing business in Waltham, and Life Edit, its gene editing technologies and R&D business in Durham, North Carolina.

The Life Edit site provides “the world’s largest gene editing toolbox” with the most diverse libraries of RNA-guided nucleases, base editors, and reverse transcriptase (RT) editors, according to Michael Paglia, ElevateBio’s chief technology officer. On the manufacturing side of its business, the flagship BaseCamp facility is designed to deliver genetic medicines from concept through to commercial production, Paglia said.

“Together, we have the enabling technologies and capabilities to help power the industry forward,” he contends. “Our goal is to move products efficiently and quickly through development and from a clinical to commercial perspective as well. We’re building a strong business to support our partners and the industry as it scales.”

From its start, ElevateBio has built a “highly” digital infrastructure including electronic batch records, an SAP enterprise resource planning (ERP), and barcode systems to ensure that the company has a “chain of custody and chain of identity” to be able to manufacture complex molecules with a high throughput, Paglia said. “Now that we have this basis, we can scale effectively.” 

Scaling its manufacturing

The company’s 140,000-square-foot BaseCamp site in Waltham, which has 14 Grade B and C cleanrooms, covers design, development, and manufacturing across a wide range of allogeneic and autologous cell therapies, gene-edited allogeneic and in vivo gene therapies, mRNA therapeutics and vaccines, as well as viral vectors — including lentiviral vectors and adeno-associated viral vectors.

For clinical and commercial manufacturing, the facility operates multiple segregated suites for cell therapy products, mRNA, and viral vectors, while leveraging automated systems for real-time review of process data and release of product.

“We have a very integrated approach in terms of how a product is translated through our facility and into the manufacturing,” Paglia said. “Because of that digital infrastructure, we have the ability to manufacture at scales across multiple cleanroom suites.”   

ElevateBio has been “very thoughtful” about its growth over the past eight years, according to Paglia. “We didn’t overbuild early,” he said, while noting that the company has achieved a level of excellence with “a greater than 98% manufacturing success rate for a lot of these novel and advanced therapies.”

Building on that momentum, ElevateBio in August 2025 announced it has been certified by the Initiative for Certification of Manufacturing Capabilities (ICMC) program for viral gene delivery, non-viral gene delivery and cell therapy manufacturing at its BaseCamp in Waltham.

The certification, administered by Dark Horse Consulting, assessed manufacturing capabilities in nine critical systems, expanding upon seven systems outlined in the U.S. Food and Drug Administration (FDA) CBER Compliance Program Guidance Manual Chapter 45 for Biological Drug Products and incorporating European Union (EU) Directive 2003/94/EC standards. 

“We haven’t been audited by the FDA yet, but we have several clients’ audits for U.S. and EU compliance,” Paglia said. “We manufacture products for both U.S. as well as EU distribution. And we were just part of a rigorous certification process through Dark Horse Consulting, which shows that we’re ready for commercial manufacturing. What the ICMC certification gives us is additional rigor that would go along with an FDA certification.”  

The nine-system ICMC assessment included: service business operations, quality, digital controls, facilities and equipment, materials, production, as well as packaging and labeling, laboratory controls, and commercial readiness. According to ElevateBio, BaseCamp Waltham is the first genetic medicine manufacturing business to receive certification across viral gene delivery, non-viral gene delivery, and cell therapy products.

The certification also supports commercial readiness — which establishes manufacturing scale-up capabilities and process validation protocols — at ElevateBio’s BaseCamp Pittsburgh, a 125,000-square-foot facility which is under construction and expected to be operational in 2027. The new BaseCamp will be the anchor tenant at the University of Pittsburgh’s 185,000-square-foot BioForge BioManufacturing Center at Hazelwood Green, thanks to a record $100 million grant from the Richard King Mellon Foundation.

“We built our reference site in Waltham and now we’re scaling to Pittsburgh, using that infrastructure that we currently have and building a full manufacturing network,” Paglia said, adding that what ElevateBio has learned in Waltham — including training and curriculum — will benefit the company as it expands to Pittsburgh. 

Technological innovation

To support its continued technology development efforts, ElevateBio created an Emerging Technology Lab with a focus on new technologies with the potential to yield high-quality and potent therapies using more robust, cost-effective, and scalable manufacturing approaches.

“We’re very in touch with the new technologies in the industry because we have what we call an Emerging Technology Lab, where we specifically work on new technologies and translating those into GMP and helping companies do that,” Paglia said.

ElevateBio’s lab serves as a beta testing center for analytical technology, automated and digital control systems, as well as new devices, reagents, and sensors, with a focus on addressing common cell and gene therapy manufacturing challenges.

“We’re working with new device companies that are trying to automate cell and gene therapy processes — so new ways of manufacturing to reduce cost of goods” including bioreactors and robots, according to Paglia. “There’s truly innovation in robotics and automation and we’re touching all of it.”  

Paglia noted that Multiply Labs, working in partnership with collaborative robotics developer Universal Robots, has developed a robotic biomanufacturing cluster that has been shown to cut the cost of producing cell therapies.

He also called out Cellares and Ori Biotech as two companies that are respectively providing innovative manufacturing technology solutions that leverage automation, as the industry looks to produce cell and gene therapies at scale.

However, Paglia was quick to add that ElevateBio hasn’t made capital investments in any of those companies. “We invest our time and we do partnerships” to help evaluate the technology, he said. “It’s been primarily around generating data and collaborations.”