Closed processing
Single-use, closed-system architecture that scales out rather than up — preserving sterility assurance and reducing operator-driven variability.
Science & platforms
The biology is irreplaceable. We protect it.
Across cell therapies, viral vectors and emerging extracellular vesicles, our scientific teams turn fragile, living mechanisms into processes that are robust, scalable and reproducible — without flattening the very biology that makes a therapy work.
Modality 01
Cell therapies
Autologous and allogeneic programs across the immune and stem-cell landscape — where the patient may be the starting material and consistency is everything.
We develop closed, scalable workflows for cell selection, activation, genetic modification, expansion and formulation, designed around potency, viability and a defensible chain of identity. Our allogeneic platforms focus on donor qualification, master cell banking and the batch economics that make off-the-shelf therapies viable.
Programs we support
CAR-T
Autologous & allogeneic
TCR-T
Engineered T-cell receptors
Treg
Tolerance & autoimmunity
NK cells
Innate immune effectors
Dendritic cells
Therapeutic vaccines
iPSC
Induced pluripotent lines
HSC
Hematopoietic stem cells
MSC
Mesenchymal stromal cells
Modality 02
Gene therapies & viral vectors
Vectors are the workhorses of genetic medicine. We build vector processes that hold their quality as they climb from research-grade to commercial titers.
Our vector teams optimize upstream productivity and downstream purification to maximize functional titer, full-to-empty ratio and lot-to-lot consistency, supporting both in vivo gene therapies and the ex vivo engineering behind cell products.
Vector systems
- Lentiviral
- Ex vivo cell engineering
- AAV
- In vivo, multiple serotypes
- Adenoviral
- High-capacity payloads
- Oncolytic
- Tumor-selective viruses
Modality 03
Exosomes & extracellular vesicles
The frontier of cell-free therapeutics — where the regulatory map is still being drawn and the analytics decide what is possible.
We support EV programs with scalable isolation, rigorous characterization, and engineered cargo-loading workflows. Because the field is young, our emphasis is on building the analytical foundation — particle characterization, identity and potency — that lets a program engage regulators with confidence.
- Scalable, GMP-aligned isolation and purification
- Particle sizing, count and identity characterization
- Engineered cargo loading and surface display
"When the regulations are still forming, the analytics have to lead. Solid characterization is how an emerging modality earns its credibility."
— Solua EV Science Team
Proprietary platform
Coherra™ — consistency, engineered in.
Our closed, modular manufacturing and data platform keeps a living process reproducible from first development run to commercial supply.
Integrated analytics
In-line process and environmental monitoring feed structured data into release-readiness dashboards, so deviations surface early — not at release.
Digital batch record
A complete, queryable record that travels with the product — accelerating review, technology transfer and inspection response.
Analytical & bioassay science
If you can't measure it, you can't release it.
Living medicines demand methods as sophisticated as the products themselves. Our analytical scientists build the assays that define quality and unlock release.
Potency
Functional, mechanism-relevant assays that demonstrate the therapy does what it claims.
Identity
Phenotypic and genetic confirmation of the right cells, vector or vesicle.
Purity
Residuals, impurities and process-related contaminant clearance.
Safety
Sterility, mycoplasma, endotoxin and adventitious-agent testing strategies.
Have a modality that breaks the mold?
The hardest problems are the ones we like best. Bring us your therapy — we'll help you make it manufacturable.