Cell & gene therapy
Stem cells, engineered lymphocytes, manipulated tissues: new therapies go beyond the development of increasingly efficient molecules by employing completely different techniques and weapons from traditional ones.
They are therapies often produced from patients’ own cells and, therefore, totally personalised. The requirements of these products, but also of the ‘raw material’ from which the products are made, are quite peculiar and different from those of traditional drugs: cells and the finished product have to be transported all over the world in containers with strictly controlled temperatures and under very strict time constraints, as is already the case today for organs to be transplanted.
Despite the efforts of biotech companies to standardise their production, these therapies are in fact derived from essentially artisanal processes, each one specific to the case it has to address, sometimes referring to a single patient.
Highly specialized - zero defect – logistics solutions
These products often require very strict storage conditions, precisely because they are live material, usually taken from the patient himself.
These drugs have to be transported not only around Europe but to countries all over the world and must follow the same procedures that apply to transplanted organs: they travel accompanied, at perfectly controlled temperatures, and within strict timelines. This imposes extreme precision in the entire process: from the packaging of the material to the way it is delivered to the hospital, with a 48-hour time window.
The situation is made even more complicated by the shortage of production hubs. Against this backdrop, the need emerges for purpose-designed logistics to cope effectively.
Our cell & gene therapy solution includes:
- Collection of samples directly at the agreed location (floor, staircase, department, office etc … of the clinical centre or laboratory);
- Provision of certified containers and packaging, possible cooling gel and dry ice on site, for sample shipment;
- Rout risk assessments / lane validation, with every shipment having at least one contingency plan in place – ensuring a zero defect shipment, every time.
- Datalogger for monitoring temperature (also in real time) and route;
- National and international transport services with trained and qualified drivers (ADR licence for transport of biologically hazardous materials);
- Real-time monitoring of the status of any shipment, temperature and urgency management through the dedicated web portal “PHSE Web Tracking” validated by an external company qualified according to GAMP 5 and FDA CFR 21 part 11;
- Express transport solutions: dedicated or urgent transport (same day, 24h or 48h delivery)
- Dedicated customer service.