Building a Strong Foundation for AstraZeneca’s House of Rapid Sterility
A sturdy home cannot be built without a solid, stable foundation.
AstraZeneca’s recent implementation of a rapid microbial method embodied this process, as Miriam Guest, Associate Principal Scientist, Microbiology, Pharmaceutical Technology and Development, explained during her presentation at the 2021 PDA Pharmaceutical Microbiology Conference. They knew the only way their “house” could be built was to lay down the “foundation”, or demonstrate method equivalency for a new rapid microbial method.
They knew that using adenosine triphosphate (ATP) bioluminescence would allow them to reduce their incubation time to seven days, compared to the compendial fourteen. However, they also knew that Charles River Laboratories had not only the technology to support ATP bioluminescence, but also the knowledge and support to help lay their foundation.
We provided a strong method equivalency study to demonstrate that the new alternative method was equivalent to, or better than, the compendial method. This document, among others that are available through our validation support packages, was customizable to fit AstraZeneca’s unique product needs.
The “House of Rapid Sterility” started with a base of statistical data which helped them build the rest of their procedures and decisions for routinely using the new technology. Among the reasons why they chose the ATP-bioluminescence method was that it allows users to test both aqueous and solid products. As one of the largest drug manufacturing companies in the world, they knew this method would be used frequently.
Aside from the technology being previously accepted for their specific application, they also knew they could use this technology elsewhere in the lab, including development and commercial operations activities. This flexibility of the ATP-bioluminescence method ultimately helped them make their final decision on the testing process.
AstraZeneca tested the final time to result across all suppliers, as they each used different methods of technology. They discovered ATP-bioluminescence technology yielded the fastest result on every test. The visual detection method varied time to result across all suppliers. For example, the Cutibacterium acnes bacteria was detected anywhere between day five and day eleven of incubation for traditional tests, but was detected in just twenty-four hours using ATP bioluminescence.
AstraZeneca also performed their own nutrient media studies prior to implementing the technology. Our media, being in conjunction with Hardy Diagnostics, was their preferred choice. AstraZeneca’s tests confirmed it was the most consistent among media from multiple vendors.
Seeing the need to find success but using a minimal amount of product, AstraZeneca used a surrogate product to build their data at a range of inocula and a full organism panel. They scaled down on all material for their worse-case sample effects study by using only a third of the normal number of rinses, nutrient media, and inocula, and then aligned it with the organism panel recommended in USP <71>. This strategy allowed them to accelerate the validation and reduce material needs while adhering to both internal and externally recommended acceptance criteria.
Partnering with us to gather method equivalency data and using our proven-effective technology and materials allowed AstraZeneca to rest assured that their “house”, or implementation plan for a rapid sterility method, could be built without crumbling.