3P Biopharmaceuticals, a member of the Infarco group, has manufactured a cell therapy based on allogeneic cardiac stem cells (AlloCSC-01) for the biotech company Coretherapix, a member of the Genetrix group.
The safety and efficacy of this cellular drug is currently being studied in the first human clinical trial for early treatment (at 1 week) of acute myocardial infarction. This clinical trial is being conducted by Coretherapix with the participation of six Spanish and European hospitals.
This milestone has been made possible through the efforts and close collaboration that both companies have maintained for some time, following the completion of several necessary stages such as the technology transfer stage, tuning, development, and the scaling and validation of processes in GMP (Good Manufacturing Practices) conditions.
The process begins in cooperation with a licensed hospital, with the donation a small piece of heart tissue from a donor who meets appropriate selection criteria. This tissue would ordinarily be discarded during surgical interventions performed routinely in cardiac surgery services. The tissue is processed at 3P in order to isolate cardiac stem cells of interest via immuno-screening and enzymatic processes. Once the stem cells have been isolated, they grow under controlled, in vitro culture conditions at low oxygen concentrations. Once enough cell biomass has been generated, it is separated into vials and frozen for use as an injection. These vials are cryopreserved in dry nitrogen tanks and stored under controlled temperature conditions until they can be administered to different patients with myocardial infarction. The whole process of the manufacture and storage of cell medicine is done in classified rooms (cleanrooms) within the area of Cell Therapy at 3P, following GMP quality standards. Each batch of drug is subjected to an extensive battery of analytical tests to ensure quality, some of which employ cutting edge technologies designed specifically for this class of drugs. Finally, 3P distributes the frozen drug to different hospitals, maintaining the cold chain temperature of liquid nitrogen, and following validated transport procedures.
This strategy allows 3P to treat different patients with a drug obtained from a single donor, while at the same time making the drug available patients immediately, rather than following weeks of production.
3P certified as a CDMO
3P is a CDMO organization (Contract Manufacturing Organization Development, CDMO) that develops and manufactures biological and cellular therapy products for preclinical, clinical trials and commercial phases for other companies under GMP conditions.
3P obtained GMP certification for the AlloCSC-01 production process in 2014. With this certification, 3P expanded the GMP approval that it had already obtained for the production and release of biologically active substances, the release of biological drugs and the release of sterile products for human medicines, veterinary use and investigational medicinal products for human use in clinical trials.
3P Biopharmaceuticals, a pioneer in the production of cell banks based on stem cells for allogeneic use in Spain, has the know-how needed to tackle co-development and manufacturing projects based on stem cells and somatic cells from different tissues products for third parties. The company is presently involved in several other advanced therapy projects for the treatment of various diseases.
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