ATMP Analytical Development for Cell and Gene Therapy
Development, optimization, implementation, and validation of analytical methods to ensure the safety, identity, purity, and potency of your cell and gene therapy products. Our analytical experts support every stage of your product lifecycle with robust, GMP-compliant testing strategies.
Method Design & Optimization
Design and development of tailored analytical methods to meet your product’s unique specifications
High‑precision, absolute quantification of vector copy number (VCN) and critical QC markers using 5-plex dPCR assaysCustom flow cytometry antibody panels and functional assays
Expertise across cellular, molecular, microbiological, and multicolor flow cytometry assays
Benefit:
You receive fit-for-purpose methods with the niche technical flexibility to match regulatory expectations and product complexity.
Validation & Compliance
Qualification and validation of analytical methods according to ICH and GMP guidelines
Development of SOPs and working instructions to ensure consistency and traceability
Benefit:
Confidence in data integrity and regulatory readiness from early development through commercialization.
Integrated Support
Seamless collaboration with manufacturing and QC teams
Analytical strategies aligned with your process development and release timelines
SCTbio Analytical Services Brochure available
Benefit:
Accelerated timelines and reduced risk through integrated, cross-functional expertise.
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.
