US-developed drug formulation could eliminate cold storage for vaccines

Article by Sam Baker

RESEARCHERS at Pennsylvania State University have developed a new type of formulation for protein-based medicines that could eliminate the need to refrigerate some vaccines.

Over 80% of biological drugs – medicines derived from living cells – and 90% of vaccines require temperature-controlled storage. The latest research, published last month in Nature Communications, developed a new oil-based drug formulation which did not degrade with increases in temperature, potentially reducing distribution costs for insulin and some types of antibodies and viral vaccines.

The “cold-chain” of drug distribution accounts for 80% of overall vaccination costs and is expected to cost US$58bn globally by 2026. There have been several successful efforts in recent years to develop formulations that limit the need to keep protein-based drugs cold, but the team in Pennsylvania say theirs is the first to work with a broad range of drugs where the formulation does not need to be tailored to a specific medicine.

Protein-based drugs are traditionally prepared in a water-based formulation. The team found that swapping out the water for a perfluorocarbon oil removed the drug’s heat sensitivity, finding no adverse effects in mice given five different unrefrigerated drugs. They found their formulation remained unchanged at temperatures as high as 90oC.

The team added that their formulation is the first to be both heat-stable and naturally sterile.

Cold storage

Cold-chain issues in vaccine distribution were brought into focus by the Covid vaccine rollout, when many developing countries struggled to afford the Pfizer vaccine which had to be stored at -70oC and packed in boxes of dry ice during transportation.

Scott Medina, a professor of biomedical engineering and lead author of the research, said that their approach could reduce costs of transportation and storage and make vaccines “more accessible and affordable for everyone”.

He said: “This would save billions of dollars currently spent on keeping these products cold throughout the supply chain and potentially enable the use of protein therapies in environments where constant refrigeration is not possible.”

However, Joshua Hallett, professor of sustainable chemical technology at Imperial College London, told TCE that while the latest research “would have a great impact on distribution” if realised at scale, a lot of research was still needed to address storage difficulties. Even if they don’t degrade with increases in temperature, Hallett said “proteins may aggregate over time” which can cause a reduction in a drug’s efficacy.

Article by Sam Baker

Staff reporter, The Chemical Engineer

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