Our Services
We run cross-functional, phase-appropriate programs.
Plasmid DNA
We offer both non-GMP and GMP plasmid DNA, supporting fermentation scales from 10–20 L for process development and 75–150 L for clinical-scale manufacturing.
Viral Vectors
Our capabilities include AAV, Lentiviral, and Retroviral vector production using both adhesion and suspension cultures, with 75–150 L bioreactors suited for clinical-scale output.
Cell Therapy
We support autologous and allogenic cell therapies, including CAR-T, CAR-M, CAR-NK, HSCs, iPSCs, and MSCs. Both automated closed-loop and traditional open-loop systems are available, along with exosome-based cell therapy solutions.
Non-Viral Gene Delivery
Our non-viral delivery platforms include LNP mRNA for gene and cell therapy applications, as well as CRISPR-Cas9 gene editing capabilities.
In Focus
Analytics & Bioassays
Molecular
qPCR/ddPCR, residuals (HCP/HCD/DNA), NGS identity & impurity profiling.
Protein/Particle
ELISA, AUC/SEC-MALS (partners), DLS, TEM (partner labs)
Cell-based
Potency assays, transduction efficiency, pseudotype neutralization (where applicable).
Micro/QC
Sterility (Ph. Eur./USP), mycoplasma (qPCR/DNA stain), endotoxin (LAL), bioburden.
Method
dev/transfer, qualification, validation plans per phase.
CMC,
Regulatory &
Documentation
IND/IMPD-ready CMC authoring, batch records, CoAs, deviation/CAPA, change control.
Validation master plans (risk-based), equipment qualification (URS/DQ/IQ/OQ/PQ)
Data integrity program (ALCOA+), eQMS workflows, archival per GDP
Program Management (PMO)
Single-threaded owner
+ weekly milestones; live dashboards (Gantt, Kanban), risk log with probability × impact; cost burn vs. deliverables.
Governance
Monthly Steering Committee; go/no-go gates aligned to your financing & clinical timelines.
Fee-for-Service
Traditional model with defined scope, deliverables, and timelines
Collaborative Partnerships
Joint development with shared responsibilities and risks
Co-Investment Structures
Long-term partnerships with aligned financial interests to accelerate commercialization
