Process Development & Tech Transfer
Development, optimization, and validation of scalable manufacturing processes tailored to your product. We lead seamless technology transfers, drive process automation, and ensure robust, GMP-compliant workflows — setting the foundation for efficient clinical and commercial manufacturing.
Cell Therapy Tech Transfer & Validation
Full management of technology transfers, including TT plan development and execution
Process qualification and analytical method validation meeting GMP and regulatory requirements
Benefit:
A personalized partnership that enables smooth development‑to‑manufacturing transitions with reduced risk, delays, and cost.
Custom
Process Design
Development of manufacturing procedures on mirrored, GMP-identical equipment to maximize operator precision
Creation of SOPs and tailored working instructions to ensure consistency and compliance
Benefit:
You get a process built around your therapy, not the other way around — with documentation ready for regulatory scrutiny.
Optimization & Automation
Process optimization to improve yield, robustness, and scalability
Implementation of closed-system automation and optimized transduction protocols to reduce variability and increase efficiency
Setup of data analysis and trending systems for continuous process monitoring
Benefit:
Faster, more reliable manufacturing with fewer deviations and better long-term performance.
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.
