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Customer
SSCB — Swiss Stem Cells Biotech | Vacallo, Switzerland
Customer Challenge
SSCB – Swiss Stem Cells Biotech was set up in 2005 within Cardiocentro Ticino in Lugano, a highly specialized hospital with a strong research vocation, where the first transplant of autologous stem cells in Switzerland was carried out, in 2004, into a heart suffering from myocardial infarction.
As a private laboratory for the production of Advanced Therapies coordinated with the umbilical cord blood bank, SSCB needed to enlarge their facility. The SSCB process involves the material collection, pre-processing, and final processing. The new equipment is needed for processing perinatal adnexa and adipose tissue stem cells.
Comecer’s challenge was to study, develop and build a production line for Cord Blood Unit Management and Mesenchymal Stem Cells processing in a privately held Cord Blood Bank.
Performance Requirements — SSCB Swiss Stem Cells Biotech
- Work with a closed system
- Minimize cross-contamination risks
- Preserve HVAC system already in place
- Comply with ATMP regulations such as GMP quality standards and national transplant regulations
- Allow for future lab relocations
Solution Highlights
Comecer designed and manufactured three customized a Modular Cell Culture Isolators (MCCI). The systems allow different methods for material input and bidirectional flows from a common entrance point. This allows them to simultaneously work on different items in different environments, making the most of common areas.
The line is composed of 3 isolators, with flexible material insertion (direct through LAF and with VPHP sterilization), multiple processing options, bidirectional working options, integrated instrumentation (3 incubators, 2 refrigerators, 2 centrifuges).
This new equipment is in operation since November 2020.
Место нахождения: Vacallo
Категория: ATMP