ADVANCED THERAPIES CDMO
Powering the Development and Manufacturing of Advanced Therapies to Improve the Lives of Patients and Families.
Cell and gene therapies are revolutionizing the treatment of rare disease and cancer. At ElevateBio, we partner with innovators to identify drug targets and manufacture clinical and commercial products to address unmet medical needs.
We do this through our long-standing commitment to quality, technology and innovation, enabling our partners to expedite drug development.
Our Services
Built For Every Stage Of Development
From early discovery and process development through technology transfer, clinical supply, and commercial cGMP manufacturing — our capabilities span the full development journey, so your program never has to restart with someone new.
Move from a gene editing target to an optimized therapeutic candidate with the data to support transition to the clinic.
Develop a scalable, robust manufacturing process built for the clinic from day one — so what works in development works at commercial scale.
Partnership is structured around your program, timeline, and stage of development - with a dedicated team that stays with you every step of the way.
Characterize your product with confidence at every stage — with custom assays and testing strategies designed to support regulatory filings.
Manufacture your program from preclinical development through commercial scale without disruption.
Navigate CMC regulatory strategy from IND through BLA with personalized support from an experienced team.
Discovery & Optimization
Gene Editing Tools & Discovery Services
Move from a gene editing target to an optimized therapeutic candidate with the data to support transition to the clinic.
- Candidate Discovery
- Candidate Engineering
- Proof of Concept
- Clinical Lead Optimization
Process Development
Develop a scalable, robust manufacturing process built for the clinic from day one — so what works in development works at commercial scale.
- Process Development
- Process Optimization
- Process Characterization
- Process Verification & Industrialization
Technology Transfer
Partnership is structured around your program, timeline, and stage of development – with a dedicated team that stays with you every step of the way.
Next-Generation Sequencing/Rapid Analytics
Get the sequencing data your program needs to make informed development decisions, faster.
Analytical Development
Characterize your product with confidence at every stage — with custom assays and testing strategies designed to support regulatory filings.
- Assay Development
- Assay Characterization
- Assay Validation
Manufacturing
Manufacture your program from preclinical development through commercial scale without disruption.
- Preclinical & Ph. 1 Manufacturing
- Late-Stage & Pivotal Manufacturing
- Commercial-Scale Manufacturing
- Lot Release Testing & Rapid Analytics
Early Clinical Trials
Gene Editing Tools & Discovery Services
Move from a gene editing target to an optimized therapeutic candidate with the data to support transition to the clinic.
- Candidate Discovery
- Candidate Engineering
- Proof of Concept
- Clinical Lead Optimization
Process Development
Develop a scalable, robust manufacturing process built for the clinic from day one — so what works in development works at commercial scale.
- Process Development
- Process Optimization
- Process Characterization
- Process Verification & Industrialization
Technology Transfer
Partnership is structured around your program, timeline, and stage of development – with a dedicated team that stays with you every step of the way.
Next-Generation Sequencing/Rapid Analytics
Get the sequencing data your program needs to make informed development decisions, faster.
Analytical Development
Characterize your product with confidence at every stage — with custom assays and testing strategies designed to support regulatory filings.
- Assay Development
- Assay Characterization
- Assay Validation
Manufacturing
Manufacture your program from preclinical development through commercial scale without disruption.
- Preclinical & Ph. 1 Manufacturing
- Late-Stage & Pivotal Manufacturing
- Commercial-Scale Manufacturing
- Lot Release Testing & Rapid Analytics
Late-Stage / BLA
Process Development
Develop a scalable, robust manufacturing process built for the clinic from day one — so what works in development works at commercial scale.
- Process Development
- Process Optimization
- Process Characterization
- Process Verification & Industrialization
Technology Transfer
Partnership is structured around your program, timeline, and stage of development – with a dedicated team that stays with you every step of the way.
Next-Generation Sequencing/Rapid Analytics
Get the sequencing data your program needs to make informed development decisions, faster.
Analytical Development
Characterize your product with confidence at every stage — with custom assays and testing strategies designed to support regulatory filings.
- Assay Development
- Assay Characterization
- Assay Validation
Manufacturing
Manufacture your program from preclinical development through commercial scale without disruption.
- Preclinical & Ph. 1 Manufacturing
- Late-Stage & Pivotal Manufacturing
- Commercial-Scale Manufacturing
- Lot Release Testing & Rapid Analytics
Regulatory Support & Commercialization
Navigate CMC regulatory strategy from IND through BLA with personalized support from an experienced team.
- Process Performance Qualification (PPQ)
- Inspection Readiness
- BLA Filing Support
- Product Licensing Inspection
- Manufacturing Optimization
Commercialization
Process Development
Develop a scalable, robust manufacturing process built for the clinic from day one — so what works in development works at commercial scale.
- Process Development
- Process Optimization
- Process Characterization
- Process Verification & Industrialization
Technology Transfer
Partnership is structured around your program, timeline, and stage of development – with a dedicated team that stays with you every step of the way.
Next-Generation Sequencing/Rapid Analytics
Get the sequencing data your program needs to make informed development decisions, faster.
Analytical Development
Characterize your product with confidence at every stage — with custom assays and testing strategies designed to support regulatory filings.
- Assay Development
- Assay Characterization
- Assay Validation
Manufacturing
Manufacture your program from preclinical development through commercial scale without disruption.
- Preclinical & Ph. 1 Manufacturing
- Late-Stage & Pivotal Manufacturing
- Commercial-Scale Manufacturing
- Lot Release Testing & Rapid Analytics
Regulatory Support & Commercialization
Navigate CMC regulatory strategy from IND through BLA with personalized support from an experienced team.
- Process Performance Qualification (PPQ)
- Inspection Readiness
- BLA Filing Support
- Product Licensing Inspection
- Manufacturing Optimization
Providing Solutions and Services Across Multiple Modalities
Cell
Therapies
Viral
Vectors
mRNA Therapeutics & Vaccines
Gene Editing
Why ElevateBio
Technology and Scale Delivering Better Outcomes
Continuous Technology Investment
We invest in automation, AI-assisted design, and process innovation, not as a one-time initiative, but as a permanent operating principle. Every dollar we invest in technology aims to reduce cost and timelines for your program.
Integrated to Eliminate Friction
Science, process development, manufacturing, and quality operate under one roof. No hand-offs. No delays between stages. One team accountable to your milestones from first experiment to final batch.
Scale Without Compromise
We build processes designed to scale from the start. The efficiency gains we achieve in development carry through to manufacturing, so reaching more patients doesn’t mean accepting higher costs or greater risk.
Team of Industry-Leading Experts
We have assembled a team of experts with first-hand experience in the discovery, development, and manufacturing of advanced therapies. Our team has been on the sponsor-side. They know the challenges, first-hand.
Unmatched expertise to accelerate your program – and industrialize advanced therapies.
Our set of technologies, end-to-end services, and industry-leading manufacturing will help you develop your therapy faster and more efficiently.
Automating Cell Therapy: A Closed, Digital Platform Delivers Consistent, Sterile, Scalable T‑Cell Production
Ready to Move Your Program Forward?
Tell us where you are in development. We’ll show you how ElevateBio can help you move faster and scale further.
// Work with us
