Burn Center Organization and Cellular Therapy Integration: Managing Risks and Costs
Architectural and organizational aspects of the Lausanne Burn Center of the Lausanne University Hospital.
The Burn Center of the Lausanne University Hospital was the first in Europe to adopt therapeutic cultured cellular product protocols. To date, various autologous and allogeneic cell therapies are elaborated and routinely produced in-house according to current Good Manufacturing Practices (GMP).
The work provides some key considerations in burn care with a focus on architectural and organizational aspects of burn centers, management of cellular therapy products, and guidelines in evolving restrictive regulations relative to standardized cell therapies.
The use of Isolators, and in particular six of our IsoCellPRO, greatly facilitated all the accreditation steps and significantly reduced the overall costs of operations. In fact, with the same size of Grade A areas dedicated to production (in closed
systems the work area of the Isolators, in open systems the work areas of the BSCs), reduced classified areas are required to install more Isolators in an A in D closed system, compared to an open system A in B solution.
Moreover, the physical separation between the product and the operator allows a greater degree of safety for both the drug and the operator.
The article is available on: https://pubmed.ncbi.nlm.nih.gov/33970273/