By Melissa Kruse
August 18, 2004 | From the windows of BioStorage Technologies, one can watch a procession of FedEx planes launching into the air from the nearby Indianapolis International Airport. Many are likely filled with frosty specimens fresh from BioStorage freezers, destined for expectant labs around the world.
When Oscar Moralez founded the specimen management company two years ago, he and CEO John Mills concluded that locating next to the second-largest FedEx hub in the world might not be a bad idea.
BioStorage built a regulatory compliant tracking and management system called ISISS (Intelligent Specimen Inventory Storage System) to allow customers to track their specimen’s precise location, temperature, and history from anywhere and in real time. This proprietary software system introduces a new level of specimen tracking information and “tagging” capabilities.
The company works with many segments of the life science industry, storing a variety of materials chiefly for pharmaceutical and biotech companies. Spinal fluid, plasma samples, protein derivatives, tissue samples, and cell lines, including the exploding market of cord blood cells, are among the freezer contents, although Moralez says BioStorage has been approached to store “all kinds of things.” “More and more people are storing samples,” he says. “Storage is becoming increasingly important for drug development and genomics.”
Biopharma companies producing drugs for clinical trials call on this Swiss bank of storage to store bulk raw materials. University labs with insufficient space, resources, or staff to manage samples also flock to BioStorage. “The regulatory aspect becomes more important and common for a lot of different reasons,” Moralez says. “If they don’t have a system that meets compliance standards, they have to find someone who does. A lot of people just don’t want to mess with it."
ISISS, Deity Among Software
ISISS -- named for Isis, the goddess of protection -- is the company’s tracking system and logistics module, enabling customers to obtain real-time information on the status of their sample.
Many facilities can store samples, but few specialize in acquiring, sorting, and shipping them. “It’s one thing to be able to stick something in a freezer, quite another to track it from its point of origin to its destination and have a complete history of where it has been,” Moralez says. “No one else has that technology. It’s not rocket science, but it is a fundamental service to any life science company.”
Moralez says his customers can query the data on samples in the facility or in transit. “They can go onto the Web query system and gather information by project, location, group, or temperature, and print management reports. They can also go online to ‘order’ samples to be pulled for shipping,” he says.
A “lite” version of ISISS will soon be available for use in remote locations, allowing clients to access BioStorage hardware and software to manage samples at their own facility.
Cold and Calculating
BioStorage presently has six clients with 25,000 to 50,000 samples under management, with 5,000 to 10,000 arriving each month.
“We want to have several million under management soon,” Moralez says. At full capacity, BioStorage will have 600 freezers, with backup power to run a further 100. It maintains 120 percent of its total electrical capacity, sufficient to store 20 million samples.
Once a patient sample is collected, the investigator or client notifies BioStorage that they are shipping the materials. Most usually send samples in a batch rather than one at a time. After the samples arrive, receivers verify the integrity of the shipment, and acknowledge receipt. After passing through various checkpoints, the samples are registered. A database is created for the client, and all data are matched with the sample and verified -- all within ISISS.
Each sample is then assigned a location. “We have a specific address for every sample that resides in the facility, so we know exactly where it is, in what freezer, row, grid location,” Moralez says.
Meeting a Need
Moralez and Mills both left Covance, one of the world's largest and most comprehensive drug development services companies, in Princeton, N.J., to start BioStorage in 2002. Together with a third founding partner, they have more than 50 years of experience in clinical, pharmaceutical, and anatomic laboratory settings. “I saw a huge need unmet and a huge opportunity to make something pretty substantial,” Moralez says. “I didn’t care to be working up some corporate ladder. It always intrigued me to start my own company.”
A former autopsy assistant, Moralez has 15 years of clinical lab experience. “If you’re in the healthcare industry, you see samples collected … moving from healthcare to drug development. I saw those things being done on a much larger scale, and with the science coming out of proteomics and genomics, we’re seeing an increase in the collection of these types of materials.
“I figured no one was doing anything about it, and what people were doing was pretty minimal. Licensers weren’t happy, so we wanted to change that.”