BD (NYSE:BDX) today shared the results from a preliminary study investigating the impact of deep cold storage on glass prefillable syringes.
Franklin Lakes, N.J.-based BD’s study evaluated deep cold storage (-20°C and -40°C) as traditional vaccine formulations are commonly stored up to about 2°C to 8°C, while mRNA vaccine formulations (the type of COVID-19 vaccine made by both Pfizer and Moderna), among other new ones, require much colder storage for over a long period of time to ensure drug-product shelf-life and potency.
BD said in a news release that such low temperatures can induce changes in container dimensions, phase transition and thermal shock, potentially compromising the functional performance of the delivery system and container closure integrity (CCI).
The company analyzed approximately 2,000 prefillable syringes (PFS) after deep cold storage, with tests conducted on several combinations of glass barrel coatings, formats, different tip and flange designs and multiple elastomeric closures with various state-of-the-art methods at -20°C and -40°C.
BD’s study found that key product functions were unaltered when stored at such temperatures and the count of subvisible particles and CCI remained unchanged when compared to those stored at room temperature.
Following the completion of the study, BD anticipates that BD glass barrel PFS systems should be suitable for use when storage temperatures of -20°C and -40°C are required. The company plans to present comprehensive study results at the 2021 Universe of Pre-Filled Syringes and Injection Devices conference on Oct. 6.
“PFS are a known factor in addressing the complexity and costs of vaccine administration. They have been shown to significantly reduce time and labor associated with drug preparation compared to vial formats, and they support dose sparing,” BD VP of R&D for pharmaceutical systems Bruno Baney said in the release. “This study confirms the promising opportunity we have to apply our leading scientific capabilities to develop innovative delivery solutions for our customers now and in the future. We’re encouraged by these results and look forward to partnering with pharmaceutical companies to further advance PFS in deep cold conditions.”