Isolator line with LAF hood for material input Blood Management and Mesenchymal Stem Cells processing

A case study of Comecer ATMP solutions

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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

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