Cellular therapies—whether stem cells, T cells, lymphocytes or the tissues that are being developed in regenerative medicine—are in the spotlight in biopharma research. Even though PROVENGE, the prostate cancer treatment commercialized by Dendreon (which is now in bankruptcy) failed in the marketplace, a renewed excitement around cellular therapies is building. In addition, the stem cell wave has yet to crest, and numerous regenerative-medicine companies are developing cell- and tissue-based products and therapies, usually starting with patients’ own cells.
Many of the researchers working in this field handle the cells (whether after extraction from a patient, moving into or out of biobanks, or as actual therapies being injected into patients) under refrigerated or cryogenic conditions—and they use non-standard formulations of serum, nutrients and preservatives to keep the cells alive, according to Mike Rice, president and CEO of BioLife Solutions (Bothell, WA). But now, BioLife is displacing many of those media with its commercialized HypoThermosol and CryoStor biopreservation media. As of the beginning of this year, he says, upwards of 175 clinical trials (some in Phase I, more in Phase II) have BioLife’s products written into the trial protocols, and in some cases (because the company developed its media with this in mind), the media becomes part of the therapy injected into a patient. BioLife filed Master Files with FDA quite a while ago, and as companies become familiar with the stability of their experimental cells and tissues stored or frozen in HypoThermosol and CryoStor, adoption has increased in the regenerative medicine space.
According to independent market-research forecasts Rice cites, the cellular immunotherapy market alone could be worth $4 billion in the next 10 years; companies doing research in it have a current market capitalization north of $11 billion. BioLife offers formulation, fill-finish services for clients as well.
Media + logistics
Now, the company is taking the next step in business development by connecting its media to container and shipping solutions, as a way to ensure that the therapy developed in the lab arrives at field trial sites, and ultimately patients, in a safe and predictable manner. “The broader pharma industry has significantly upgraded its cold chain capabilities over the past five years or so, and we’re riding on that evolution,” he says, asking “Who knows how many experimental trials failed because the survivability of the cells involved was never confirmed?”
The company’s already announced Biologistex service comprises insulated shipping containers (from SAVSU Technologies, a Santa Fe, NM vendor), integrated with a cellular communications, a payload monitoring system, and a Web-based app so that the shipper can monitor a package throughout its journey. The SAVSU partnership was announced in 2013; now, the company has brought in Kevin O’Donnell, former senior partner of Exelsius Cold Chain Management, as VP, cold chain standards, practices and compliance. “Commercial pharma tracks cold chain shipments in part to develop a profile for specific trade lanes,” he says, “but we’re planning a system that will track each shipment, individually, all the way to when it is presented to the patient.” The Biologistex service is being designed as a “self service” offering, letting the shipper decide who and how a shipment is transported, but O’Donnell and Rice leave the door open to collaborate with logistics service providers already operating in the clinical space in the future.