The following is a guest blog by Kevin O’Donnell, Vice President, Cold Chain Standards, Practices & Compliance, BioLife Solutions
As forecast by the White House 2012 National Bioeconomy Blueprint, increased cell manufacturing research activities are ushering in an era of significant medical advancements, improvements to public health, and tremendous economic benefits to the next generation of biotech. But as biotech companies fasten their seatbelts for this long-term scientific journey, they have more immediate journeys to oversee: the day-to-day transport of their biologic payloads. Every spoiled or lost shipment is a small scientific setback, and a financial loss. What’s more, with the commercialization of cell therapies, we can expect regulatory scrutiny over the quality, storage, and shipment of biologic materials to become increasingly stringent over time – yet another compelling reason to refine and retool management of the shipping process.
The Cell Manufacturing Consortium has identified cell preservation, distribution and handling as one of the six primary areas of focus critical to commercialization. Many biologics must be transported via temperature-controlled systems to keep their therapeutic properties intact. What’s more, temperature is not the only variable that can jeopardize cell stability, survival, viability, recovery, function and yield. Other potential threats include humidity, light, oxygen, shock, pressure, vibration and exposure to X-rays. Near UV light can have photosensitizing effects on certain human cell cultures, causing a decrease in the ability of DNA to transform bacterial cells. Radiation destroys photoreactivating enzymes, triggering unexpected biological effects. Shock and vibration can also impact cell therapies or tissue engineering used in bone regeneration.
While it is impossible to eliminate the risk of human error or transportation delays, a holistic digital integration of processes related to the transportation supply chain would have significant clinical and economic benefits. Current Good Manufacturing Practices (cGMP) call for processes, tools and data to monitor and manage the movement of biologic materials across time and space. The use of packaging systems with multi-function environmental monitoring and GPS tracking will provide greater visibility and control over the cold chain shipping process.
One solution for the shipment of critical biologic materials is a cloud-based cold chain management service. For example, BioLife Solutions offers a cloud-based service that is an integrated logistics and track & trace web application for managing the shipment of time- and temperature-sensitive biologic materials. The app works in conjunction with a state-of-the-art precision thermal shipping container with embedded payload monitoring, GPS location tracking, and cellular communication electronics that transmit critical shipment information to the cloud.
The app’s data parameters include accurate payload and ambient temperature, light exposure, relative humidity, barometric pressure, and the shipment’s current location and estimated delivery time. The app enables users to configure actionable, real-time alerts to notify stakeholders and downstream recipients of the package location, as well as when it is delivered and opened. A patent-pending countdown timer tracks the remaining shelf life or stability of the biologic materials.
Adopting such integrated supply chain data management systems empowers shippers to make informed, data-driven decisions on the quality of biologic shipments, in real-time. If the integrity of a shipment is compromised, a replacement can be shipped out without delay. The integrated app generates printable records and reports, making it easier to identify process gaps, negligent logistical practices, and other transportation risks that could threaten the quality and integrity of advanced therapy products.
The adoption of integrated data management systems within the supply chain will put an end to the current “best practice” of validate-and-assume test shipments and periodic monitoring. Shippers will be empowered to make informed, data-driven decisions on the quality of biologic shipments in real-time, rather than post-shipment. Along with a new era in biotechnology, we can look forward to new era in the shipping of biologics.
BioLife Solutions designs, manufactures, and markets proprietary and generic cGMP biopreservation media products for cells, tissues, and organs. The company also performs contract research and offers consulting to optimize customer specific biopreservation protocols and processes.
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