The company predicts an increased demand for GMP raw materials
CellGenix has completed the second phase of its facility expansion. The expansion involved reconstructing its production facility for cytokines and implementing an automated filling and freeze-drying line.
By implementing the automated filling and freeze-drying line and increasing bulkware production footprint, finished product capacity for cytokines is substantially increased.
This will enable CellGenix to meet demand for critical raw and ancillary materials as more customers reach late-stage clinical development and commercialisation of their cell and gene therapies. Scaling up from phase I or II clinical trials to large-scale commercial manufacturing, the demand for GMP cytokines often rises by several magnitudes.
Consequently, a secure supply chain is imperative. A delay in delivery or change in product quality could lead to delays in production, not only increasing costs but also putting precious patient samples in jeopardy.
The expanded facility enables CellGenix to streamline its production processes. The automated filling, stoppering and capping system (operates under an Open Restricted Area Barrier System (ORABS) and) is compliant with EU GMP Annex 1 for the manufacture of sterile medicinal products, also taking into account the version which is currently under revision.
During the first expansion phase in 2018, CellGenix added additional space and personnel in its quality control, R&D, logistics and warehouse departments.
“The expansion of our facility is a result of the robust, sustainable, and profitable growth, generated by long standing and trustful customer relationships we achieved over many years. CellGenix is now well prepared for the future growth of the cell and gene therapy market. It supports our goal to further establish CellGenix as a key provider in the fight against disease, preferred supplier or raw and ancillary materials and trusted partner for large scale manufacturing of cell and gene therapies.” said Felicia Rosenthal, Chief Executive Officer at CellGenix.