# SCTbio

SCTbio is a Czech biotechnology company that provides contract development and manufacturing organization (CDMO) using cGMP services of Advanced Therapy Medicinal Products (ATMPs).
It operates in Europe and North America. The company is recognized as good in the development of autologous cell-based products, cell banking, and all needle-to-needle good manufacturing practice (GMP) operations, including a validated apheresis collection sites network, product manufacturing, quality control, GMP storage, Qualified Person (QP) and Quality Assurance (QA) release, and worldwide drug products supply for clinical and commercial scales.

## History

SCTbio was founded on the 1st of July 2021, and is a part of the larger PPF Biotech network. SCTbio was initially part of the Sotio group, providing drug development and manufacturing capabilities. Its CEO, Luděk Sojka, has been part of the PPF Biotech network and Sotio since 2011.
On November 1, 2021, Sotio changed its name to SCTbio.

## Operations

SCTbio conducts global operations in Europe and the USA. The cGMP cell manufacturing facility is based in Prague, Czech Republic. The GMP facility features over 2,000 square meters of total space, including 420 square meters of total clean room area (4,520 sq ft). The company offers the ability to manufacture genetically modified products that require the separation of viral and non-viral components. This physical segregation minimizes any risk of cross-contamination.

## Services

* CGMP Manufacturing and Quality control: SCTbio provides full production services covering autologous, or allogenic cell and gene therapy products, and in collaboration with sister Cambridge facility recently expanded to the area of viral vectors. SCTbio leads manufacturing processes from various starting materials, including apheresis products, whole blood, and tumor tissues. The company also conducts quality control testing based on a variety of cellular and molecular methods and provides rapid sterility testing.
* Analytical Development: SCTbio conducts development, optimization, and implementation of analytical methods, including expertise in cellular, flow cytometry, molecular, and microbiology-based methods, provided with the development of standard operating procedures, as well as contributing to methods qualification and validation.
* Process Development: SCTbio contributes to the design and development of customized manufacturing procedures, in line with cGMP standards to create new working instructions and standard operating procedures, as well as developing technology transfer plans and execution.
* Logistics Services & Apheresis Collection: SCTbio has contributed to a number of clinical trials and developed their logistical services while operating under SOTIO. They have a vast network of logistical services that include shipping and validation of apheresis products and provide technical expertise on the harvesting of peripheral blood mononuclear cells.
* Procurement & Warehouse Management: SCTbio participates in the procurement of raw materials for product development and adheres to GxP practices. The company has its own storage facility in Prague that provides different controlled temperature from -190° (liquid nitrogen) to room temperature.
* Quality and Regulatory Support: SCTbio provides support and services for quality system checks in the European Union, United Kingdom, and United States. They oversee the final drug products in each of these markets and have flexible quality systems that are in line with the territories in which they are established, using electronic Quality Systems and Quality Document management systems that implement custom design and monitoring capabilities.