Advanced Therapy Analytical Development: Methods Built to Hold at Scale
ElevateBio’s analytical development team supports cell therapy, viral vector, and mRNA programs with the same analytical rigor: methods designed to survive GMP, not just pass validation. Cell therapy is where the team’s experience runs deepest, but the infrastructure, QbD framework, and QC integration are built to serve every modality you’re working in.
// Analytical
Development Services
Build the Analytical Strategy First. Avoid Remediation Downtime Later.
A method that works in a research lab often fails in a GMP environment, where it runs all day, every day. Each failure triggers an investigation. ElevateBio builds every program’s analytical foundation through a quality by design (QbD) framework: the Analytical Target Profile defines what a method must measure and to what performance standard, before any instrument is chosen.
Mike Giffin
Director of Analytical Development
- Phase-appropriate assays designed with the next phase already in view
- Potency control strategy built to meet FDA and EMA expectations through BLA/MAA
- Methods stress-tested for GMP conditions before transfer to QC
Elevated Insights
From gene editing to biomanufacturing, learn more about the cell and gene therapy industry from our team of industry-leading experts.
AD and QC Build Every Method Together Before It Enters GMP
Most analytical failures aren’t surprises. They’re the predictable result of methods designed in isolation, built by a development team without enough input from the QC analysts who will run those methods every day. ElevateBio structures AD and QC as a collaborative team precisely to close that gap.
Before any method moves into GMP testing, both teams work through every potential failure mode together: what changes when a reagent lot shifts, when the assay runs on a different day, when a result sits at the edge of spec. Questions get answered in hours, not days.
Analytical Development
- Custom assay development and optimization across all supported modalities
- Flow cytometry, PCR, ddPCR, ELISA, and cell-based potency assays
- Stability program design and execution, and method transfer
QC Analytics and Validation
- Method qualification, validation, and lifecycle management
- Clinical routine testing, lot release, and OOS investigations
One Analytical Team Covers Every Modality You’re Working In
ElevateBio’s analytical team covers cell therapy, viral vector, and mRNA programs within the same analytical infrastructure, without switching groups or subcontracting internally.
Cell Therapies
(CAR-T, TCR-T, TIL, gene-edited, allogeneic)
- Multi-parameter flow cytometry including rare event detection (residual TCR+ cells below 0.5% in allogeneic programs)
- Full potency strategy: genetic (ddPCR/qPCR), protein expression (flow), and functional cell-based assays
- Cytokine release (IFN-γ, ELISA, Luminex) and cytotoxicity for CAR-T and TCR-T
Viral Vectors
(LVV, AAV)
- Vector potency, physical and biological titer
mRNA
- Drug substance characterization and release testing support
Investing in the NGS Rapid Analytics That Cell Therapy Needs
Manufacturing has gotten faster. Release testing hasn’t.
Clearing a cell therapy batch today means running three separate safety assays that weren’t designed for living, time-sensitive products: sterility (up to 14 days), mycoplasma (up to 28 days), and adventitious agent testing (often outsourced). In small autologous runs, sample volume alone can be the constraint.
ElevateBio is building a single NGS-based safety assay to replace all three. Early data demonstrates detection and species-level identification of multiple bacterial, fungal, and viral contaminants in the same run with no separate investigation required.
| Current State | Rapid Analytics Target | |
|---|---|---|
| Number of assays | 3 (sterility, mycoplasma, adventitious agent) | 1 |
| Assay duration | 5–14 days | 4–5 days |
| Release TAT | 8 days | 6 days |
| Sample volume | mLs | µLs |
| COGS (sterility + myco) | Baseline | ~65% reduction |
| Contaminant ID | Separate investigation | Real-time, same assay |
| Automation potential | Limited | Fully automation-ready |
For autologous programs, shorter vein-to-vein time is a clinical outcome, not just an operational one. The NGS lab is the foundation. Rapid analytics is what we’re building on top of it.
Sequencing Results in Days, Not the Weeks You’d Wait Elsewhere
Most programs that need sequencing data face an uncomfortable choice: send samples to an external vendor and wait weeks, or build internal capability from scratch. ElevateBio is a third option.
Our NGS core is integrated directly with manufacturing and process development. Automated bioinformatics pipelines return amplicon results in under a week. ElevateBio is the only Twist NGS Pro Lab in New England.
The team is actively qualifying NGS-based safety testing for GMP.
Explore ElevateBio’s Next-Generation Sequencing capabilities
Automation That Removes the Variables Before They Reach a Batch Record
Most QC failures aren’t execution failures. They’re design failures: methods built for ideal conditions that weren’t tested against analyst turnover, reagent lot changes, or a routine Tuesday shift. ElevateBio evaluates and deploys automated analytical platforms to engineer those variables out before they reach a GMP environment.
- Accellix Platform: Automated cell phenotyping; results in 30 minutes; CV below 10% inter- and intra-instrument
- ProteinSimple Ella / Dynex DS2: Automated ELISA for cytokine release, eliminating manual wash steps
- Integra Assist Plus: Benchtop pipetting robot for infectious titer and core AD/QC testing
- Chemometec XM Platform: Rapid cell count and viability with higher dynamic range
- Raman Spectrophotometry: In development for raw material identity and purity verification
Fewer hands-on steps mean faster lot release and a more defensible batch record as programs scale toward commercial.
Resources
Accelerating Innovative Cell Therapy Development Through Phase-Appropriate Potency Control
ElevateBio’s Next-Generation Sequencing Core: Meeting the Challenges of Cost, Time and Data Quality with Expertise and Collaboration
Sequencing-based analytics offer potential for rapid sterility and adventitious agent testing
Frequently Asked Questions
What analytical development services does ElevateBio offer?
ElevateBio provides analytical development and QC testing for cell therapy, viral vector, and mRNA programs, including custom assay development, flow cytometry, PCR and ddPCR, cell-based potency assays, method transfer, and GMP lot release testing. With analytical development and QC working as a closely integrated team, troubleshooting and method transfer move faster than at CDMOs where these functions operate in isolation.
How does ElevateBio approach potency assay development?
ElevateBio starts with an Analytical Target Profile, which defines what the method needs to measure and how well it must perform before any instrument or reagent is selected. For CAR-T and TCR-T programs, this means building a potency strategy that addresses all relevant mechanisms of action: at minimum cytokine release, and often cytotoxicity and protein expression as well. The team has supported potency programs from preclinical development through Phase 2 and beyond, with direct regulatory submission experience shaping how methods are structured.
What is ElevateBio's rapid analytics program?
ElevateBio is working on a single NGS-based assay to replace the three-test safety panel required for cell therapy lot release: sterility, mycoplasma, and adventitious agent testing. Early data demonstrates detection of multiple bacterial, fungal, and viral contaminants. The target is to cut release TAT from 8 days to 6 days, reduce sample volume from mLs to µLs, and achieve approximately 65% COGS reduction for sterility and mycoplasma testing, with real-time contaminant identification in the same assay.
Does ElevateBio offer standalone NGS services?
Yes. ElevateBio’s NGS core supports sequencing services for cell and gene therapy programs and beyond: vector genome characterization, insertion site mapping, CRISPR on/off-target assessment, transcriptional profiling, and custom panel design. Amplicon turnaround is under one week. ElevateBio is the only Twist NGS Pro Lab in New England, with automated bioinformatics pipelines on Illumina, Oxford Nanopore, and 10x Genomics platforms.
Explore ElevateBio’s Next-Generation Sequencing capabilities
How does ElevateBio handle incoming sponsor methods?
ElevateBio reviews incoming methods in close collaboration with the sponsor before transfer. The goal isn’t to override the sponsor’s approach but to pressure-test it together: can this method run reliably in a compliant environment day after day? Where optimization is needed (antibody titration, panel design, system suitability parameters, acceptance criteria), AD and the sponsor work through it jointly before the method moves into QC. Catching and resolving those issues together, before an active campaign begins, is what prevents them from becoming schedule problems later.
Ready to Talk Analytics?
Programs that get analytical strategy right early spend less time remediating it later. Start with a conversation about where your program is and what it needs.
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