Cell therapies
Autologous and allogeneic programs across the immune and stem-cell landscape, engineered for potency and consistency.
Cell & Gene Therapy CDMO
Living medicines, made manufacturable.
Solua Therapeutics partners with innovators to take cell and gene therapies from a promising idea to a reproducible, inspection-ready commercial process — without losing the biology that makes them work.
3GMP facilities, two continents
540+Process-development programs
19Regulatory inspections passed
Why Solua
A single partner for the whole therapeutic journey.
Cell and gene therapies break the rules of traditional manufacturing. The product is alive, the patient may be the starting material, and the process is the product. We were built specifically for that reality.
From a single integrated quality system, our teams carry your program through process development, analytical method qualification, GMP supply for the clinic, and the technology transfer that readies you for commercial launch — under one roof, one timeline, one accountable partner.
Modalities
Deep expertise across living & genetic medicines.
We work in the formats that define modern therapeutics — and the emerging ones still finding their footing.
Gene therapies & viral vectors
Robust, scalable viral-vector platforms supporting in vivo and ex vivo programs from research to commercial titers.
Exosomes & EVs
Emerging extracellular-vesicle therapeutics, with isolation, characterization, and cargo-loading workflows built for an evolving regulatory frontier.
Services
End-to-end capability, modular by design.
Engage us for a single phase or the full lifecycle. Either way, your program never leaves the integrated quality system.
Process development
Designing robust, scalable, reproducible processes that survive scale-up and the rigor of regulatory scrutiny.
cGMP manufacturing
Clinical and commercial supply in segregated, single-use suites — autologous and allogeneic.
Bioassay & analytics
Potency, identity, purity and safety methods developed, qualified and validated for release.
Tech transfer & readiness
Pre-approval inspection readiness and seamless transfer between sites, partners and scales.
Regulatory & CMC
CMC strategy, authoring and agency interactions to keep your filing on the front foot.
Tissue sourcing support
Qualified starting-material acquisition and chain-of-identity from collection to clinic.
The Solua journey
From New Product Introduction to commercial launch.
Every program moves through five quality checkpoints — each a gate where data, not optimism, decides the path forward.
Discover
Feasibility, candidate assessment and the New Product Introduction intake.
Develop
Process and analytical development against a target product profile.
Clinical
GMP supply for first-in-human through pivotal trials.
Validate
Process performance qualification and pre-approval readiness.
Commercial
Licensed, inspected, resilient supply at launch and beyond.
Proprietary platform
Coherra™
Our closed, modular manufacturing and data platform that keeps a living process consistent from bench to commercial — closed-system processing, integrated environmental and process analytics, and a digital batch record that travels with the product.
- Closed, single-use, scale-out architecture
- In-line process analytics and release-readiness dashboards
- Chain-of-identity from collection to infusion
Built for biology
Consistency is the whole game.
In living medicines, variability is the enemy. The biology is irreplaceable — so the process around it has to be relentlessly reproducible.
Coherra™ was engineered to do exactly that: hold a delicate process steady as it scales, capture every parameter as structured data, and surface the signals that keep batches in specification and inspectors confident.
Track record
Decades of GMP, measured in outcomes.
25+
Years of GMP manufacturing experience
540+
Process-development programs delivered
19
Regulatory & pre-licensing inspections passed
3
GMP facilities across two continents
Tell us about your therapy.
Whether you are scoping feasibility or readying for a pivotal trial, our scientists will map the fastest credible route from where you are to a manufacturable, inspection-ready process.