Every Capability Your Program Needs. One Team That Stays With It.
Cell and gene therapy programs need capabilities that span the full development journey, from gene editing design through advanced therapy process development and GMP manufacturing. ElevateBio puts them in one place, investing in automation, AI-assisted design, and process innovation so partners access those advances without carrying the cost or risk of building them. That approach has delivered a 98% batch success rate across all cell therapy, viral vector, and mRNA programs in 2025.
// Manufacturing &
Development Services
- 98%
Batch Success Rate in 2025 - 30+
Preclinical and Clinical Programs Supported - 10+
Advanced Therapy Modalities Enabled - ICMC™
Commercial Readiness Certified - 5
Editing Modalities Supported by AI-Enzyme Discovery - 10B+
Protein Collection That Can Be Mined for Functionality
Advanced Therapy Manufacturing & Development Services
Most programs lose time when the team that built the process hands off to one that wasn’t there. ElevateBio was built to prevent that. Process development, manufacturing, analytics, and quality operate within the same organization. The scientists who develop your process stay with it through tech transfer and into GMP manufacturing. And the technology improves continuously, so every incoming program can benefit from the most current tools and methods ElevateBio has validated and deployed.
- The scientists who build your process lead the transfer to GMP
- 40+ in-house QC release methods
- Automation and advanced analytics available to every program
- No proprietary platform. Technology decisions stay with you
- CAR-T, TCR-T, TIL, Treg, NK, HSC, iPSC, LVV, AAV, mRNA, and more
Learn more about
Gene Editing Design & Optimization
Move from a gene editing target to an optimized therapeutic candidate, with the data to support transition to the clinic.
Process Development
Build a scalable manufacturing process from day one, so what works in development works at commercial scale.
Technology Transfer
Transition your process to GMP manufacturing without losing what your development team built. ElevateBio’s process development scientists stay embedded through transfer and into production.
cGMP Manufacturing and Automation
Transition your process to GMP manufacturing without losing what your development team built. ElevateBio’s process development scientists stay embedded through transfer and into production.
Analytical Development
Characterize your product at every stage with custom assays and testing strategies built to support regulatory filings.
Next-Generation Sequencing
Access integrated NGS capabilities built into the manufacturing operation, with ongoing investment in rapid release testing designed to compress cell therapy batch release timelines.
Regulatory CMC
Navigate CMC strategy from IND through BLA with a team that has direct experience taking advanced therapy programs to market.
Quality
Meet the standards regulators expect with a quality framework built specifically for advanced therapies.
Generative AI
Explore how ElevateBio’s AI-driven enzyme discovery designs novel editors from the ground up, with centralized IP ownership that simplifies licensing for your program.
Gene Editing Design & Optimization
For programs still defining the edit, ElevateBio’s work starts before manufacturing does. Finding the right gene editing approach shouldn’t require building a platform internally. ElevateBio brings five editing modalities, AI-driven enzyme discovery, and deep protein engineering expertise to match the right editing approach to your program and deliver a high-quality data package ready for your team’s next decision.
- Five editing modalities spanning the full spectrum of disease biology
- AI-driven discovery across a catalog of over 10 billion protein sequences
- Up to 3 gene editors delivered to your lab, ready to run on your samples
- Standard terms and a fixed deliverable. Start in weeks, not months.
A Different Kind of Partnership
Most CDMOs operate as black boxes. ElevateBio is structured differently. One organization, direct visibility, and a team that stays with your program whether the engagement starts in gene editing or on the manufacturing floor.
- Direct program visibility: sponsors see what is happening before issues become surprises
- Partner-in-Plant access: qualified sponsor personnel on the floor during engineering and GMP runs
- Real-time batch visibility: dashboards and camera feeds support transparency during execution
- Shared accountability: science, manufacturing, analytics, and quality answerable to the same program outcomes
What Partners Say
Partner Testimonials
Collaboration with ElevateBio lets us expedite analytical and process development as well as outsource all manufacturing, and we can leverage their cell biology expertise throughout the process. Just ten months after launch, we had a baseline manufacturing process that took about one year off the time to IND.
The speed and quality of this collaboration exceed our expectations. ElevateBio didn’t just manufacture our therapy – they helped us establish a blueprint for base editing manufacturing.
Resources
Frequently Asked Questions
Does ElevateBio work with early-stage programs?
Yes. At ElevateBio we encourage engagement as early in the program as possible. Upstream choices in materials, unit operations, and analytical strategy determine what becomes possible at GMP. Those decisions are best made with manufacturing in mind from the start.
For programs beginning with a gene editing question, ElevateBio’s discovery team works before manufacturing enters the picture. A Proof of Concept engagement delivers up to three gene editors to your lab for evaluation on your own samples. Standard terms, fixed deliverable, typically under six months.
For programs ready for process development or tech transfer, ElevateBio builds processes designed for GMP from day one. The scientists who develop your process lead the technology transfer and stay engaged through the first successful GMP run.
What advanced therapy modalities does ElevateBio support?
ElevateBio’s primary manufacturing focus is cell therapy, supporting autologous and allogeneic programs including CAR-T, TCR-T, TIL, Treg, NK, HSC, and iPSC-derived therapies from preclinical through commercial scale. ElevateBio also manufactures mRNA therapeutics and vaccines, lentiviral vectors, and AAV. For programs that begin before manufacturing, ElevateBio’s gene editing team supports therapeutic design and optimization across five editing modalities.
How does ElevateBio handle technology transfer?
ElevateBio embeds process development scientists through tech transfer rather than handing off to a separate manufacturing team. The scientists who build your process stay with it through engineering runs, GMP manufacturing, and beyond. Qualified sponsor personnel are welcomed on the manufacturing floor during transfer, with real-time dashboards and camera feeds providing direct visibility into batch execution.
What does ICMC Commercial Readiness Certified mean?
ICMC Commercial Readiness Certification is an independent audit conducted by Dark Horse Consulting that verifies a CDMO’s readiness to support commercial-scale manufacturing against U.S. and E.U. evaluation standards. ElevateBio is the first CDMO to earn multi-modality ICMC certification, covering viral gene delivery, non-viral gene delivery, and cell therapy manufacturing
Learn more about ICMC certification at Dark Horse Consulting
How does ElevateBio differ from other cell and gene therapy CDMOs?
ElevateBio invests continuously in automation, AI-assisted design, and advanced analytics, making those advances available to every program. Partners choose what to adopt and when. There is no proprietary platform driving recommendations and no pressure to adapt a process that doesn’t need to change.
The team has lived the sponsor reality firsthand. That experience shapes how the organization is structured. Process development, analytical development, quality, regulatory CMC, and cGMP manufacturing operate under one roof, with no handoffs between stages. The same scientists stay with a program from development through GMP manufacturing.
Ready to Build a More Integrated Path to GMP?
Tell us what stage your program is at. We’ll walk you through ElevateBio’s capabilities and map where you need to go.
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