ONCO-DENDRIGENEA™

Dendritic cells- based active immunotherapy for the treatment of cancer solid tumors ( asymptomatic or minimally symptomatic metastatic tumor related gastric/colorectal/glioma/glioblastoma/lung/melanoma/breast human cancers).

The procedure consists of the followings Standard Operating Procedures:

Collection:

The dendritic cells are collected by oncologist in sterile environment according to a standarized venupuncture procedure 150-300 c.c peripheral blood. Tumour tissue is collected via FNA biopsy. (1-2 gr. of solid tissue)

Processing:

The peripheral blood sample is being coded with a unique barcode for its traceability both during the processing and after the release. Sample processing is being carried out immediately upon receive with validated procedures in a completely closed ...

The peripheral blood sample is being coded with a unique barcode for its traceability both during the processing and after the release. Sample processing is being carried out immediately upon receive with validated procedures in a completely closed system (biogenea® set). In particular, the dendritic cells are being isolated from monocytes centrifugation and maturated to specific cancer peptides according to certified SOP. The whole procedure is being carried out in a laminar flow class A/B (Annex I - February 2008 EU guideline for the cGMP standards). There is a complete monitoring system inside the laminar flow 24h a day controlling the air as well as the germs.

read more

Quality Control:

A maturated dendritic cell count is being performed both prior to and after the procedure. Prior to the procedure a functional dendritic cell test is being performed. The maturation of dendritic cell analysis is carried out using the automated flow ...

A maturated dendritic cell count is being performed both prior to and after the procedure. Prior to the procedure a functional dendritic cell test is being performed. The maturation of dendritic cell analysis is carried out using the automated flow cytometry analyzer. After the procedure completion, a small amount of the final product is being used for the final numerical counting of the maturated dendritic cells using flow cytometry SOPs protocol. A small amount of the sample is being cryopreserved and thawed especially for a viability test of dendritic cells after the cryopreservation procedure. Using this procedure we can guarantee that the viability and the tumour lysate - maturation of dendritic cells are intact during the cryopreservation. The viability test is being performed using the automated luminometric system, while the maturation test is being performed using a standarised protocol. A small amount of the stem cell culture is controlled for the presence of aerobic and anaerobic germs using the automated blood culture system, while in parallel the automated genetic analyzer is used for the detections of HBsAg, as well as for Hepatitis C, HIV Ι/ΙΙ , Toxoplasma , Syphilis and CMV.

read more

Long term Cryopreservation & Product Release:

Only after the completion of all the quality tests isolated tumour lysate maturated dendritic cells are stored in temperatures reaching the -196C ( in these conditions all the metabolic procedures are stopped ) and document/certificate of ...

Only after the completion of all the quality tests isolated tumour lysate maturated dendritic cells are stored in temperatures reaching the -196C ( in these conditions all the metabolic procedures are stopped ) and document/certificate of cryopreservation is issued. Product Release contains a quality certification.

read more

Clinical Indications:

ONCO-DENDRIGENEA™ is released only according to hospital exemption procedure (1394/2007 E.C)