APCEDEN® Treatment Plan
The process of creating a personalised (autologous) therapy, starting from the leukapheresis process to it's production and shipping back for infusion requires a well coordinated logistics support.
APAC's logistics team ensures the timely pickup of the samples and shipping to the clinical site.
The therapy requires two separate cell collections from the patient—a tumour tissue sample (biopsy) and PBMCs collection (apheresis).
Tumour cell collection
Patient first undergoes surgery or biopsy at the hospital for collecting fresh tumor tissue. The tumor tissue is collected and stored in special Tissue Transport Medium supplied by APAC Biotech. It is then sent to APAC's Central Lab via specialised biotech logistics.
Patient also undergoes a Leukapharesis procedure at the hospital to collect the PBMCs or Peripheral Blood Mononuclear Cells. These act as starting materials for preparation of Dendritic Cells in the lab. Following Leukapharesis, Nutriprep Medium is injected into the bag. The PBMC bag is then collected from the hospital and shipped to APAC's Central lab for processing.
The manufacturing process lasts for 8 days. Six doses are made simultaneously each having 5-7 million Dendritic cells (DCs).
The logistics department of APAC Biotech provides an end to end support that begins from picking up of the tumor tissue and the Leukapheresis Bag from the hospital and delivering it to the Central Lab and ends with shipping the doses back to the clinical site for infusion.
At each step there are stringent check points before either the bag or the tumor tissue enters the processing department. Similarly the prepared doses are subjected to US FDA approved quality checks before it is handed over to the logistics department for dispatch. The quality checks performed are summarised in computerised reports which are shipped along with the doses.
APCEDEN® Personalised Immunotherapy shipped to the Cancer Patient
Once manufactured, the doses are cryopreserved and shipped in a qualified dry shipper via APAC's specialised logistics team to the clinical site for administration as per the cancer patient's dosage schedule.
All the six doses are prepared simultaneously and are administered every 2 weeks making the treatment last for 3 months.