APCEDEN®Treatment Regime

Step 1:-

This therapy starts with patient identification and screening.

After screening the patient, he/she would sign the consent form and the registration process begins at hospital, the information is passed to APAC Biotech for the generation of the UPIN and logistic initiation of the process.


Step 2:-

On the suggestion of the treating Physician dates are fixed for the Tumor collection and Leukapheresis. After registration a Tumor collection kit is shipped to the hospital for

collection of fresh surgical tumor into a special medium (Tissue transport Medium), provided by the APAC team, which is then shipped back to APAC central lab from the clinician . Once the biopsy material is received it undergoes processing and the Leukapheresis is planned as per the suggestion of the treating Physician. There are certain prerequisites which are to be monitored before the leukapheresis process such as the TLC count which should be between 8000-10000 cells/cumm. If it is below 8000 cells/cumm, then a growth factor is given a day prior to the leukaphersis process. Before the leukapheresis starts, the patient needs to go for some baseline tests that are treated as control for future purpose. These include radiological assessment and biochemical blood and immune parameters of the patient. All the reports of the patient are handed over to the APAC Central lab.

Step 3:-

The logistics department of APAC Biotech provides an end to end support that begins from picking up of the tumor tissue to the Leukapheresis Bag and ends when the final dose is back to the clinician for infusion. At each step there is stringent check point before either the bag or the tumor tissue enters the processing department. Similarly once the dose is ready it undergoes US FDA approved quality check points before it is handed over to the logistics department for dispatch. The Logistics department takes care of the collected PBMC bag and ships the bag to APAC central lab's quality control department. Only after the later gives it's green signal the bag is sent for further processing of the cells to manufacture APCEDEN®.

Step 4:-

Once the Leukapheresis bag enters the lab for preparation of Dendritic cell after a quality check clearance, it takes 8 days for the doses to be ready. On the 8th day all the six doses for the patient are ready and after various quality checks and parameter analysis the 1st dose of the patient is released and the rest 5 doses are stored in liquid nitrogen which are administered to the patient every 15 days.

Step 5:-

After eight days of cell processing in the lab, six doses of APCEDEN® are prepared which is further sent to the quality control department for rigorous quality checks. The 1st dose is then shipped to the hospitals for infusion on 8th day through cryo-shipping in a dry shipper.

DOSING SCHEDULE

APCEDEN® is ready for infusion after the 8th day post receiving the leukapheresis bag. The 1st dose is shipped on the 8th day to the clinical site for infusion. Remaining subsequent five doses are shipped at every 15 day intervals. The whole immunotherapy cycle completes in 84 days after the leukapheresis procedure.