Certifications & Resources
We operate within a rigorous regulatory framework, offering our global partners a strategic gateway to de-risk their path to market. Our ATMP GMP certification, together with MIA and GMO authorizations, ensure peak accountability, covering the full scope of global apheresis logistics, production, testing, and batch release. We provide an audit-ready, cross-border bridge that guarantees product integrity and compliance from clinical trials through to commercialization.
GMP Certificate - Cell and Gene Therapy (ATMPs)
SCTbio has been inspected last March 2026 by the National Regulatory Agency, the State Institute for Drug Control, SÚKL, and obtained the renewal of its GMP certificate.
GMP Certificate - Biologics Import and QP Certification
SCTbio has been inspected last March 2026 by the National Regulatory Agency, the State Institute for Drug Control, SÚKL, and obtained the renewal of its GMP certificate.
CIR Certification from the Government of France
SCTbio has obtained the CIR Certification (Crédit Impôt Recherche) from the Ministry of Higher Education, Research and Innovation of the Government of France, enabling our French customers to benefit from significant tax deductions on the services they contract from us.
Manufacturing and Importation Authorization (MIA) – ATMP / Gene Therapy IMPs
SCTbio holds a valid Manufacturing and Importation Authorization (MIA) – ATMP / Gene Therapy IMPs, issued by the State Institute for Drug Control, SÚKL, covering manufacturing, quality control testing, batch certification, and importation activities.
GMO Authorization – BSL‑1 & BSL‑2 / Viral Vector IMP Activities
SCTbio is registered as a user of genetically modified organisms under Czech national biosafety legislation, authorized for contained use in Risk Categories 1 and 2 (BSL‑1 and BSL‑2) for activities involving cell lines and viral vectors.
Import/Export Permit for Leukapheresis Products
SCTbio holds a valid Import/Export Permit issued by the Ministry of Health of the Czech Republic, authorizing the import and export of leukapheresis materials for the manufacture of autologous investigational medicinal products.
Additional QA/QP Documentation – Available Upon Request
SCTbio is committed to transparency, traceability and openness. Upon request, our QA and QP teams can provide relevant documentation, and we regularly undergo and welcome client audits.
SCTbio Brochure
SCTbio is providing end-to-end GMP manufacturing and development services to accelerate cell & gene therapy programs.
SCTbio Brochure For Analytical Services
The team provides a full range of services ensuring GMP compliance for the entire life cycle of drug development, including analytical services such as cell-, flow cytometry-, molecular biology- and microbiology-based methods.
SCTbio Video
SCTbio is located in the heart of Europe in Prague, Czech Republic, enabling ideal logistics services. Discover our GMP manufacturing capacity and take a tour of our Prague facility: