Start-up BioLOGIS ties cargo security to environmental monitoring

Recently-formed company BioLOGIS is trying to make its mark in the pharmaceutical industry by offering cargo security, shipment tracking and biometric condition monitoring from a single vendor.

BioLOGIS was set up at the start of July as a subsidiary of established security specialist Hi-G-Tek with the specific aim of meeting the needs of the biopharmaceutical industry, including securing cargo from theft, detecting intrusion, and monitoring temperature, humidity, motion and a raft of other variables that could affect the quality of a shipment.

The company's chief executive Keith Nalepka told SecuringPharma.com that BioLOGIS can draw on a broad range of technologies developed by its parent company Hi-G-Tek, including proprietary miniaturised wireless sensors, a comprehensive enterprise software platform and a portfolio of seals, locks and other security devices. The system can offer real-time GPS tracking, "geo-fencing" to ensure predetermined routes are followed and records the chain of custody.

"To date pharmaceutical companies have been able to deploy all these technologies, but not from a single vendor," said Nalepka, who has extensive pharma supply chain experience after stints at Forrest, Purdue and Elan.

"The US Food and Drug Administration is now asking drugmakers whether they are doing all they can to secure medicines in transit, and there are two separate bills in the Senate covering the issue," said Nalepka.

"Added to that, there is an increase in the proportion of biologic drugs coming through development for which tight temperature control is critical, so we believe the attention of the pharmaceutical industry is focused more closely in this area than ever before," he added.

Hi-G-Tek's technology is already in routine use in a number of other applications, such as securing and tracking shipments of nuclear waste, military supplies and petrochemicals, but until now the company has not targeted the pharmaceutical sector specifically.

BioLOGIS sees the opportunity in pharma as being across the entire supply chain - upstream from raw materials suppliers to the pharmaceutical manufacturer and downstream from the manufacturer to the consumer - and also across all phases of development.

For example, "securing clinical trial materials is increasingly being viewed as a critical objective for drugmakers, because the material is often extremely high-value and hard to replace easily," said Nalepka.

Thieves may target a shipment of clinical materials speculatively, to see what it contains, but even if they do not end up taking the shipment the break in the chain of custody - and the potential for adulteration of the material - presents a headache for drugmakers.

Hard data on cargo thefts is hard to come by, but the FDA issued an open letter to the pharmaceutical industry and other stakeholders earlier this year in which it said it was "very concerned about the increase in cargo and warehouse thefts of FDA regulated products."

In the letter the agency said there had been "several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling."

Using BioLOGIS' technology, cargo can be electronically sealed - either at the full truckload (FTL) level or less than truckload (LTL) level - with cargo data loaded onto the tags. Multiple locking devices can be employed, while devices record tampering and issue alerts in real-time based on the customer's pre-defined criteria.

The company is looking into integrating the security system with the thermal coats used more and more to insulate pharmaceutical loads in transit, said Nalepka.

BioLOGIS is currently in negotiations with a number of pharmaceutical companies to carry out pilot testing of the technology, according to Nalepka. At the moment the company has four non-disclosure agreements signed and the aim is to have 10 or more in the coming months.