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GMP
What can Cell Factory GMP do for you?

Cell Factory, in addition to producing cell therapy products and perform quality controls according to GMP in experimental clinical protocols, may take part to authorized multicenter studies for institutions who do not have GMP facilities. Following are few examples of GMP products to be employed in cell therapy, produced by Cell Factory:

  • Hematopoietic progenitor cells from cord blood expanded in vivo
  • Production of dendritic cells with the aim of realizing anti-tumor vaccination;
  • Production of mesenchymal cells from bone marrow, adipose tissue, umbilical cord blood, for various applications in hematology and regenerative medicine (running applications in neurology, nephrology, pulmonary, dermatology, orthopedics, hematology);
  • Endothelial progenitors from bone marrow to be employed in revascularization interventions in carvicascular pathologies
  • Progenitors from leukapheresis for hepatic regeneration

A few example of services Cell Factory can carry out on your behalf:

  • Production and quality control of experimental clinical protocol already authorized /from phase I to III)
  • GMP quality control of cell therapy products
  • Carry out validation, according to GMP, of third parties clinical experimental protocols; Cell Factory is fit to provide validation protocols and prepare Investigational Medicinal Product Dossier (IMPD) for approval of clinical protocols and to assist the proponent throughout the authorization process
  • Develop potency assays for cell therapy products (task carried out with the collaboration of Cell Factory Research Department ;
  • Production for third parties involved in multicenter studies authorized in other European countries.

In addition to supplying products for cell therapy and performing GMP quality control within internal experimental clinical protocols, Cell Factory may offer the following services:

  • Carry out separation of hematopoietic stem cells (CD34+ and CD133+ cells) from leucocyte apheresis or bone marrow for various hematopoietic transplants, to treat leukemia, lymphoma, myeloma and solid tumors;
  • Conduct enrichment or depletion of various lymphocyte populations (CD3, CD19, CD4, CD8, CD25), for protocols supporting bone marrow transplantation;
  • Clinical-grade enrichment or depletion of various cell subtypes.

Cell Factory experience in this field is the best guarantee of success for clinical sites interested in carrying out innovative therapies.
Do not hesitate to contact us (rosaria.giordano@policlinico.mi.it) for further information, for a visit to our new GMP facility, or to have a quotation for your cell product.What can Cell Factory GMP do for you?

Cell Factory, in addition to producing cell therapy products and perform quality controls according to GMP in experimental clinical protocols, may take part to authorized multicenter studies for institutions who do not have GMP facilities. Following are few examples of GMP products to be employed in cell therapy, produced by Cell Factory:

  • Hematopoietic progenitor cells from cord blood expanded in vivo
  • Production of dendritic cells with the aim of realizing anti-tumor vaccination;
  • Production of mesenchymal cells from bone marrow, adipose tissue, umbilical cord blood, for various applications in hematology and regenerative medicine (running applications in neurology, nephrology, pulmonary, dermatology, orthopedics, hematology);
  • Endothelial progenitors from bone marrow to be employed in revascularization interventions in carvicascular pathologies
  • Progenitors from leukapheresis for hepatic regeneration

A few example of services Cell Factory can carry out on your behalf:

  • Production and quality control of experimental clinical protocol already authorized /from phase I to III)
  • GMP quality control of cell therapy products
  • Carry out validation, according to GMP, of third parties clinical experimental protocols; Cell Factory is fit to provide validation protocols and prepare Investigational Medicinal Product Dossier (IMPD) for approval of clinical protocols and to assist the proponent throughout the authorization process
  • Develop potency assays for cell therapy products (task carried out with the collaboration of Cell Factory Research Department ;
  • Production for third parties involved in multicenter studies authorized in other European countries.

In addition to supplying products for cell therapy and performing GMP quality control within internal experimental clinical protocols, Cell Factory may offer the following services:

  • Carry out separation of hematopoietic stem cells (CD34+ and CD133+ cells) from leucocyte apheresis or bone marrow for various hematopoietic transplants, to treat leukemia, lymphoma, myeloma and solid tumors;
  • Conduct enrichment or depletion of various lymphocyte populations (CD3, CD19, CD4, CD8, CD25), for protocols supporting bone marrow transplantation;
  • Clinical-grade enrichment or depletion of various cell subtypes.

Cell Factory experience in this field is the best guarantee of success for clinical sites interested in carrying out innovative therapies.
Do not hesitate to contact us (rosaria.giordano@policlinico.mi.it) for further information, for a visit to our new GMP facility, or to have a quotation for your cell product.
 
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