CellGenix Completes Facility Expansion for GMP Raw Materials Demands
Complete the form below to unlock access to ALL audio articles.
CellGenix GmbH, announces the completion of the second phase of their facility expansion. CellGenix has reconstructed and expanded their production facility for cytokines and implemented a state-of-the art automated filling and freeze-drying line.
By implementing an automated filling and freeze-drying line and increasing bulkware production footprint, finished product capacity for cytokines is substantially increased. This continues to enable CellGenix to meet the fast-growing demand for critical raw and ancillary materials as more customers reach late-stage clinical development and commercialization 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 newly designed and expanded facility enables CellGenix to streamline their production processes. The automated filling process also provides increased accuracy and reduced risks, which further increases the safety of their preclinical and GMP cytokines. 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 new version which is currently under revision.
In a first expansion phase in 2018 CellGenix added additional space and personnel in its quality control, R&D, logistics and warehouse departments. By finishing both expansion phases, CellGenix has further strengthened their position as a leading supplier for large scale manufacturing in the cell and gene therapy space.
“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.” Felicia Rosenthal, Chief Executive Officer at CellGenix.