E!115078, Carrier4TSC, Magle Chemoswed AB

Purpose and goal:

The main goal of the Carrier4TSC project is the development of a dissolvable microcarrier to enable the adhesion and growth of mesenchymal stem cells (MSC) in a bioreactor process, and an efficient cell harvest while preserving the therapeutic potential of MSC. The novel microcarrier will be combined with a MSC specific coating in order to allow MSC to expand in a serum-free media and detach from the microcarrier by its dissolution, without causing damage to the cells.

Expected results and effects:

We plan to deliver a novel microcarrier to expand the yields of functional, therapeutic mesenchymal stem cells (MSC). MSC will grow in an environment without animal components on the starch microcarrier covered with an MSC-specific coating. The innovative value lies in the support of the serum-free culture in combination with an effective bioprocess and a non-proteolytic cell detachment from the biodegradable microcarriers.

Microcarriers will be optimized to ensure a mechanical support and a high surface-to-volume ratio when applied in a bioreactor. Approach and implementation:

Firstly, we will develop the prototypes of the novel MSC-specific microcarriers. The corresponding bioprocess will be developed interlinked. When we have a final prototype, we will enter the verification and validation phase as well as initiate the business development to quickly enter the market.

In the production phase, we will scale up of the microcarrier production under GMP conditions. After project termination, we will further address the certification of the microcarrier according to regulatory requirements and will complete the quality statement documentation.