Modern microbial methods and advanced technologies can provide significant benefits to biopharmaceutical companies, including enhanced sensitivity, cost and time savings, and continuous monitoring support.
Yet, despite these benefits and the extensive regulatory guidance available, their adoption is still not common. This is often because the challenges of assessing new technologies can add to a lack of understanding of the initial evaluation and implementation process. For example, a common oversight is not using a wide range of internal stakeholders early in the evaluation process.
This situation resulted in a new collaboration of industry working groups, including the BioPhorum Alternative and Rapid Micro Methods Bio-fluorescent Particle Counters (BFPC) team, which joined forces to support the awareness and adoption of modern microbial methods.
The Modern Microbial Methods (M3) collaboration has now written an article Initial Evaluation Roadmap for Modern Microbial Methods, which outlines the high-level topics, the questions to ask, and which internal stakeholders should be involved in an evaluation. It breaks down the process into four steps:
- The initial technology assessment
- Data and compliance risk
- Cost considerations
- Overall instrument evaluation.
Published by the Parenteral Drug Association, the article is aimed at a broad audience, including decision-makers who may have limited experience with evaluating and implementing modern microbial methods.
“I really value the collaboration across the industry to progress in areas of new technology adoption,” said Miriam Guest, Principal Microbiologist, New Modalities & Parenteral Development, AstraZeneca, UK. “The discussions that take place are an incredible opportunity to learn from industry peers. We’re all at different stages of the journey in various technology areas, and open collaboration is certainly a key enabler to transformation.”
Respond to issues quickly
The benefits of these modern methods apply across the microbiological control strategy. For example, they may help enhance your data integrity, process robustness, process understanding, and let you quickly respond to drifts in real-time, rather than waiting several days to discover a problem through traditional microbiological techniques.
Traditional methods can offer a fit-for-purpose solution to quality assurance but may have some limitations. As products evolve and patient reach expands, more technologies are becoming available to enhance awareness and decrease the time to a result. These new technologies also improve the current state of limited data available during the microbial review of manufacturing environments, processes, and products.
But to do all of this successfully, you need a robust evaluation process.
The hurdles of adopting modern microbial methods may seem large, so you must understand the limitations of current methods and assess the risks before adopting your new method. You can then mitigate those risks when developing your implementation plan for the new technique and adopt a clear framework to reduce the obstacles.
This is why the roadmap can significantly minimize your challenges and give you a foundation for success. As well as BioPhorum Alternative and Rapid Micro Methods BFPC team, the M3 collaboration includes the Kilmer Community Rapid Microbiology Methods Group, the Online Water Bioburden Analyzer (OWBA) Working Group and the Process and Environmental Monitoring Methods (PEMM) Working Group. The PDA article is one of this group’s first publications, with more to follow.