Biopharmaceutical supply chains are among the most complex and costly processes on the planet. CAR T-cell therapies, which can cost hundreds of thousands of dollars to create, can be rendered ineffective with even the slightest temperature deviation during the lengthy apheresis, manufacturing and final product logistics process. The stakes couldn’t be higher: not only is a costly medical therapy on the line, but often, so is a patient’s life.
Recognizing this high risk of failure, biopharmaceutical companies are increasingly customizing aspects of their supply chains. Whether they’re creating unique equipment, packaging, or data reports, they’ve turned to Cryoport’s experts to increase control, understanding and efficacy of the development and distribution process.
Many clients first find Cryoport when they’re seeking a specific product or service, such as cryogenic shipping logistics. But they’re often pleasantly surprised to discover our host of subject matter experts – our engineers, scientists, and logistics managers – who can dive into the details of the client’s latest challenge and provide unique solutions.
Here’s a sampling of the types of custom products and services we’ve created for Cryoport clients:
- A new premium shipper, produced collaboratively with our client and built for a specific temperature range
- Leak-proof accessory bags and other custom packaging items tailored to client packout
- Customized racks to safeguard the customer’s specific therapy packaging
- Shipping lane validations for complex domestic and international routes, including shippers in different temperature ranges as part of the complete needle-to-needle journey of a cell therapy
- Packaging and shipper qualifications across a range of thermal and/or physical testing (ISTA, IATA, ASTM) to qualify shippers for clinical use with client packout or test varied pack outs to ensure product integrity
Establishing greater control during the supply chain process is especially critical now. Cell and gene therapies are in their nascent regulatory stages: the FDA has not yet provided specific cell and gene therapy regulations, and the ISO only recently released a set of guidelines for their distribution. We anticipate regulations becoming much more detailed and stringent, with increased requirements for tracking the history and safety of equipment and processes. When we support a client with customized solutions, we ensure their supply chain is in full compliance with current regulatory standards.
Cryoport’s expertise in supporting cell and gene therapy development has grown over two decades – we have supported clients anywhere from pre-Phase I clinical trials through commercial and patient distribution – and our experts have advised the ISO committee on the new cell and gene therapy distribution guidelines found under ISO 21973. Thus, our clients can rest assured that our supply chain support services, even the bespoke ones, will be compliant with current and future regulations alike.
This article is the first in a series covering Cryoport’s customized service solutions. Following articles will cover tailored solutions we’ve provided for clients, such as shipping lane validation, specialized packaging, data services and more. Please stay tuned as our Cryoport Consulting Services team works to highlight our myriad offerings and client results.
