New order

Seismic shifts in the pharma landscape are well underway. A record 13 cell or gene therapies are poised to be approved in 2023. Moreover, 222 new clinical trials were started for such advanced therapies last year. The number of approved advanced therapies is expected to continue to grow year-on-year for the foreseeable future.

In parallel, at the end of last year, the FDA Modernization Act 2.0 removed the requirement for new drugs to be tested in two animal species before being tried in humans in the US. Similar steps are afoot in Europe, with the European parliament voting in favour of plans to phase out animal testing in research back in 2021.

These moves have been driven, in part, by increasing maturity of in vitro human models. We can expect to see greater prevalence of spheroid, organoid and organ-on-chip type assays in pharmaceutical development.

The cell culture media, a solution of essential nutrients for cell growth, is key to both of these significantly widening avenues in pharmaceutical development. This has made fertile ground for the cellular media market, which is now one of the fastest growing sectors in pharma and biotech.

Most pharma and biopharma companies purchase cell culture media in one of two forms: powder or liquid. Powdered medium is easier to ship and store, and has improved scalability once the correct formulation is found.

Dry product can suffer, however, from issues with sterility, as well as uniformity when mixing. Meanwhile, the hydration step can also be time-consuming and labour-intensive. On the other hand, liquid media are generally supplied sterile, require fewer steps before use and can be ordered in small batches suitable for developing personalised biotherapeutics.

Furthermore, the cost is much greater due to increased packaging, weight and cold chain storage, all of which significantly increase the cost and environmental impact associated with liquid media.

Nucleus Biologics and Stoic Bio recently released a benchtop machine, the ‘Krakatoa’, which sits in the middle ground of powder and liquid media. Somewhat like a Nespresso machine, the Krakatoa accepts biodegradable pods to solubilise sterile media at the point of use.

The pods are stable at room temperature, eliminating the need for cold chain storage and are significantly lighter than bottles of liquid media thus hugely reducing shipping costs and emissions.

At the same time, the pod-based Krakatoa permits small batch (500 mL) production. This facilitates quick iteration through different formulations with smaller test volumes and reduced testing waste when compared to dry powder media; additionally, scalability is improved as compared to liquid media when the right formulation is found. In essence, the Krakatoa combines the advantages of both liquid and powder cell culture media.

Per 500 mL of media, Nucleus Biologics estimates that the Krakatoa pods produce about 65% less greenhouse gases than traditional media.

Overall, the Krakatoa represents a great example of how sustainability focused innovation can bring improvements in costs and efficiency, as well as reductions in waste and carbon emissions.