Next-generation T-cell response platform for autoimmune diseases: Production development and documentation

Purpose and goal

Neogap develops diagnostic test kits for autoimmune and neurodegenerative diseases using an innovative technology that enables detection of autoreactive T cells. The test results provide deeper insight into disease mechanisms and may become an important tool in the development of curative therapies. The first product is designed for Multiple Sclerosis. The aim of the project is to define a production process that results in a high-quality product that meets user expectations.

Expected effects and result

Expected results are documentation, with Standard Operating Procedures, as well as a plan for setting up a pilot line for testing.

Planned approach and implementation

In collaboration with a consultant 1) define relevant process flows 2) create necessary documentation, so called Standard Operating Procedures, linked to said flows 3) set requirements for premises and equipment for production 4) compile the plan for implementation and testing of a robust production process