Cell Therapy Manufacturing and Quality Control
Professional cGMP manufacturing cell and gene therapy products and viral vectors, using established production platforms and validated quality control methods. Our integrated and flexible approach ensures reliability, compliance, and scalability from clinical to commercial stages across diverse cell types and indications — all under one roof.
Tailored Manufacturing
Approaches
Manufacturing of autologous and allogeneic CGT products, adaptable to T cells, NKs, DCs, iPSCs or MSCs
Support for various starting materials including apheresis, whole blood, and tumor tissue
Cryopreservation capabilities of drug substance (DS), drug product (DP), and QC samples
Customizable processes to meet clinical or commercial needs
Benefit:
Clients gain flexibility and scalability through our CDMO-CRO integration without compromising compliance or quality.
Integrated cGMP QC of Cell Safety, Sterility & Identity
In-house QC testing using cell-based, microbiological and molecular methods
Rapid sterility testing (BACTEC, membrane filtration)
Safety monitoring for RCR/RCL, Mycoplasma (qPCR), endotoxins (LAL, Endosafe)
Identity testing: CAR Expression (Flow Cytometry), VCN quantification (dPCR)
Routine cell count, concentration, and viability via NC200 and Vicell platforms
Benefit:
Faster turnaround times and built-in assurance of safety and identity.
Client-Centric Flexibility
Transparent Person-in-Plant access available
Independent storage systems for added security
Full infrastructure for uninterrupted operations
Benefit:
Transparency, control, and peace of mind throughout the manufacturing process.
Cell Banking & Labeling
Preparation and characterization of Master Cell Banks (MCB) and Working Cell Banks (WCB) – research-grade and GMP-grade
GxP-compliant labeling and re-labeling services aligned with global clinical standards
Benefit:
Secure, traceable, and compliant handling of critical materials.
Integrated cGMP QC of Cell Purity, Potency & Stability
In-house QC testing for functional potency: T-cell activation, killing assays, cytokine release
ELISA testing for process‑related impurities: BSA, benzonase, host‑cell proteins
Residual plasmid and physicochemical analysis: pH, osmolality, lactate, glucose, appearance
Raw material testing and stability studies covering the full product lifecycle
Backup systems for all critical materials and outsourced tests
Benefit:
Reduced dependency on external labs and a robust path to batch release.
More Ways We Help
cGMP Manufacturing and Quality Control
Cell therapy and viral vector
expertise with robust in-house QC capabilities
Lentiviral & Gammaretroviral Vector Production & Testing
Viral vectors development and manufacturing - scalable RUO & GMP grades
Analytical
Development
Analytical development include
method development,
optimization, and validation
Process Development & Tech Transfer
Scalable, optimized processes
with successful transfer from lab to GMP
Apheresis Collection
& Logistics
Seamless needle‑to‑needle coordination across 150+ EU/US legacy apheresis sites — from apheresis to patient delivery
Storage
& Distribution
Proprietary global GxP logistics, controlled storage, and cold chain management
Quality & Regulatory Support & Qualified Person Services
QP batch release under EU GMP and global compliance support
Extensive Global Heritage in Apheresis Management
SCTbio draws on a long-standing legacy of working with more than 150 qualified and trained cell-collection sites across Europe and the USA. We provide dedicated apheresis support, with rapid reactivation and site‑specific procedure alignment to secure high‑quality clinical starting material.
