SCTbio

Overview

SCTbio describes itself as a full-service European cell and gene therapy CDMO focused on somatic and genetically modified cells and viral vector solutions. It supports Advanced Therapy Medicinal Products (ATMPs) from early development through GMP manufacturing and global logistics.

Capabilities

• cGMP manufacturing and quality control, with cell therapy and viral vector expertise and in-house QC
• Lentiviral and gammaretroviral vector production and testing, offered at RUO and GMP grades
• Analytical development, including method development, optimization, and validation
• Process development and technology transfer from lab to GMP
• Apheresis collection and logistics across more than 150 EU and US qualified apheresis sites
• Storage, distribution, and cold chain management under GxP controls
• Quality and regulatory support, including QP batch release under EU GMP

Scale and Track Record

The company reports roughly two decades of experience in cell and gene therapy manufacturing, more than 2,000 GMP batches manufactured, and about 12,000 IMPs delivered worldwide. Its facilities total 2,000 m², including 420 m² of Class A/B/C GMP cleanrooms, and three Qualified Persons are on site for batch release.

Locations

SCTbio's global headquarters and EU business office are in Prague, Czech Republic. Its US business office is in Boston, Massachusetts. The company was founded in 2021 as a spin-off from SOTIO, and its Boston office was established in 2024.