Advanced Therapy cGMP Manufacturing That Performs, Batch After Batch
As an advanced therapy CDMO, ElevateBio delivered a 98% batch success rate across cell therapy, mRNA, and viral vector programs in 2025. The margin for error in this work is small. A failed batch isn’t just lost material. It’s a delayed trial, a disrupted patient schedule, and a question mark on your program’s viability.
// cGMP Manufacturing
and Automation
Three Modalities, One Facility Network, One Team
Cell Therapies
Autologous and allogeneic programs from process development through cGMP production.
Viral Vectors
Lentiviral and AAV manufacturing at multiple production scales.
mRNA
Drug substance and drug product manufacturing at any stage of development.
Our manufacturing model addresses variability at three levels: facility design, digital execution, and precision planning.
- Together, facility design, digital execution, and precision planning remove 70-80% of variability sources before a batch begins
- Recipe-driven manufacturing execution system (MES) enforces every operational sequence
- Electronic batch records (EBRs) capture real-time process data and support review-by-exception lot release
- Precision planning integrates QC, supply chain, and clinical schedules weeks ahead
- 40+ QC release methods in-house, no outsourcing delays
For Gene Editing Programs
Partners working with ElevateBio’s Gene Editing Tools & Discovery Services have a direct path to GMP manufacturing through the same organization. Discovery and manufacturing continuity, under one roof.
Your Team, Inside Our Manufacturing Floor
Most CDMOs treat sponsors as external observers. ElevateBio’s Partner-in-Plant program gives qualified sponsor personnel direct access to the manufacturing floor, working alongside our operators during engineering runs and, where appropriate, during GMP manufacturing.
- Qualified sponsors on the manufacturing floor during engineering and GMP runs
- Embedded sponsor SMEs for rapid issue triage during tech transfer
- HD camera feeds for real-time cleanroom visibility
Automation and Technology Built Into the Manufacturing Model
Every program that partners with ElevateBio gets access to the same technology investments, regardless of stage. We evaluate, test, and deploy new manufacturing tools as standard practice. Partners benefit without carrying the cost or risk of building that capability themselves.
- Closed systems and automated platforms reduce manual variability
- MES, LIMS, and ERP are fully integrated to reduce delays across manufacturing, documentation, and release
- Automated environmental monitoring for Annex 1 compliance
- Preferred partner status with Sartorius for the Eveo Cell Therapy Platform
- Partnership with Ori Biotech on automated bioreactor platforms for cell therapy manufacturing
- Six Sigma methodologies, rapid test methods, and at-line monitoring across programs
Partners decide how far to go. We make sure the options are there.
ICMC Certified. Independently Validated.
ElevateBio’s Waltham, MA facility is ICMC™ Commercial Readiness Certified, the first CDMO to hold this certification across multiple advanced therapy modalities. The ICMC program is administered by Dark Horse Consulting and evaluates nine manufacturing systems against U.S. and E.U. commercial-level standards, covering viral gene delivery, non-viral gene delivery, and cell therapy manufacturing, going beyond standard FDA inspection criteria.
- Standardized, reproducible manufacturing processes
- Reduced regulatory risk
- Accelerated timelines and higher probability of technical success
- Time and resource savings in development and manufacturing
Two Facilities. One Standard of Manufacturing.
Waltham, Ma
Flagship Facility
- 140,000 sq ft
- 11 Grade B suites, 3 Grade C suites
- Cell therapy, lentiviral vector, and mRNA
- MES, EBRs, LIMS, and real-time environmental monitoring
- Active clinical programs ongoing
- ICMC™ Certified
Pittsburgh, PA
Expansion Facility
- 125,000 sq ft at Hazelwood Green
- Modular, automation-ready suites
- Digital backbone built in from the ground up
- Integrated fill and finish
- First GMP batches in 2027
Pittsburgh is designed to prove what advanced therapy manufacturing can achieve at commercial scale.
What Partners Say
Partner Testimonials
As far as overall work experience with the CDMO, the site, the personnel, I would rank ElevateBio far and above the best CDMO from that perspective. We hit the IND amendment and 30-day review on the day we had planned a year and a half prior. That degree of execution and not having to repeat runs was a huge benefit.
Real-time visibility lets us focus on science rather than worrying about what's happening in the cleanroom.
Just ten months after launch, we had a baseline manufacturing process that took about one year off the time to IND.
Resources
Engineering Reliability In Cell Therapy Manufacturing: Integrated Systems and Transparent Collaboration
From Innovation to Impact: Building on Pittsburgh’s Legacy to Industrialize Advanced Therapies
Frequently Asked Questions
What experience does ElevateBio have in advanced therapy manufacturing?
ElevateBio has supported 30+ preclinical and clinical programs across discovery and manufacturing, spanning cell therapy, viral vector, and mRNA, including CAR-T, TCR-T, TIL, allogeneic cell therapy, and lentiviral vector programs. The manufacturing team has direct experience across all major cell therapy modalities and has taken programs through tech transfer, clinical supply, and toward commercial manufacturing.
Does ElevateBio manufacture autologous and allogeneic cell therapies?
Yes. ElevateBio manufactures both autologous and allogeneic programs, including CAR-T, TCR-T, and TIL, from process development through cGMP production. Autologous programs receive chain-of-identity management from apheresis receipt through final product delivery. Allogeneic programs are supported with the process consistency and analytical depth that scaling donor-derived cells demands.
What advanced therapy modalities does ElevateBio support?
ElevateBio supports more than 10 advanced therapy modalities across cell therapy, viral vector, and mRNA, including CAR-T, TCR-T, TIL, Treg, NK cells, HSC, iPSC-derived therapies, lentiviral vector (LVV), AAV, and mRNA. All are available from early clinical through commercial scale. For programs beginning in gene editing, ElevateBio’s discovery team supports therapeutic design across five editing modalities before manufacturing begins.
What is the Partner-in-Plant program?
ElevateBio’s Partner-in-Plant program gives qualified sponsor personnel direct access to the manufacturing floor during engineering runs and, where appropriate, during GMP manufacturing. Sponsors work alongside ElevateBio operators during critical aseptic transfers, with real-time visibility into how their process behaves at scale.
How does ElevateBio handle the cGMP transition?
At ElevateBio, the scientists who develop your process stay engaged through cGMP manufacturing. They design the batch records, train the operators, and carry the process knowledge from development into every clinical batch. There is no new team to bring up to speed.
What is ICMC certification and does ElevateBio have it?
ICMC (the Initiative for Certification of Manufacturing Capabilities) is a rigorous independent audit administered by Dark Horse Consulting. It evaluates nine manufacturing systems against U.S. FDA and E.U. commercial-level standards, covering viral gene delivery, non-viral gene delivery, and cell therapy manufacturing. ElevateBio is ICMC™ Commercial Readiness Certified, the first CDMO to achieve this certification across multiple advanced therapy modalities. For a CMC leader conducting diligence, it can reduce the time, cost, and uncertainty associated with facility evaluation by providing documented, third-party evidence of commercial readiness.
Ready to Move Your Program Forward?
Every program starts the same way. Tell us where you are. We’ll show you what a manufacturing partnership looks like
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