Defining a 250mL cassette standard: Let’s think inside the box!

An article in Nature Reviews from May 2018 revealed 753 preclinical to phase 4 trials in cell therapy are underway around the world.

As these products advance through various stages of approval, supply chain managers are tasked with manufacturing and delivery of final products. While the intricacies of transfecting cells and developing new cell and gene therapy products are layered in expertise and IP – one simple, yet underestimated aspect is defining the final product delivery cassette.

The cassette is simple right? It’s an aluminium frame used to protect blood bags and assist in heat transfer during the controlled-rate freeze step of product development. The cassette has no real impact on bioprocessing. It is simply the delivery container for the payload. Common cassette sizes are 25mL, 50mL, 150mL – and the 250mL cassette common in CAR-T.

 

250ml cassette

Both products currently use a 250mL cassette with the exact same dimensions. This is the standard many freezer and cryogenic lab product companies like Brooks Life Sciences design to.

 

Manufacturers of equipment used for the delivery and storage of these cassettes are challenged in one simple way: No standard outer dimensions to design for a 250mL cassette. Depending on the manufacturer, a 250mL cassette could vary in dimensions on either side – or in the thickness of the cassette. Does this remind anyone of the ANSI/SBS standards development? This has significant unrealized impact on industry economics and efficiencies.

To help illustrate this point, let’s look at the shipping industry. Years ago, product was brought to the shipyard, train station, or depot where product would be loaded for delivery. This evolved into logistics teams providing their own versions of shipping containers. These containers were compatible with transport equipment. Dimensions matched the transport device, the container moved easily using supplier equipment, and the locking mechanism helped secure containers to the transport vehicle.

This created challenges as containers began intermingling between transport companies. Container dimensions were not always compatible. People didn’t have the right equipment to lift or move various containers. And even If they could – there may not have been a way to secure the load to their transport vehicles.

Today, the shipping container industry sings. Standards are defined to address the size of container, assist with moving containers, and fitting containers to various chassis. These developments have made the world smaller – and the world economy bigger according to The Box author, Marc Levinson.

I believe the world of cell and gene therapy needs to define standards for similar reasons. Without these standards, the industry is limited in how quickly it can expand to support new therapies. Freezer manufacturers, logistics companies, and hospitals receiving final patient product all struggle with the impact of slight variations in cassette dimensions.

Cryogenic freezer automation companies like Brooks Life Sciences have decided to build around what industry leaders have already chosen as their cassette dimensions. Manufacturers of other LN2-based equipment like dry shippers must design to accommodate many products. Selecting cassettes with dimensions just outside of what may have been optimized can add significant inefficiencies and cost.

Last, when product is received by the hospital or a third-party logistics hub near the patient, they need to have the right racking to support various cassettes – or spend time (and add risk) by swapping the product to compatible equipment. This could can put product at additional unnecessary risk of bag fractures or unwanted temperature cycling.

Please contribute to the conversation by taking this three-question survey. Results will be shared at the upcoming Phacilitate Leaders World and World Stem Cell Summit in Miami, FL.