Several alternative and rapid microbiological methods (ARMM) are now available to detect and enumerate microbiological contamination. Regulatory authorities are encouraging the biopharmaceutical industry to adopt these innovative technologies – but the path is sometimes clouded. Although there are some guidance documents available, a holistic description of the entire end-to-end implementation process is still missing.
This is why BioPhorum has written A framework for the evaluation, validation and implementation of alternative and rapid microbiological testing methods.
“Microbial control is an area where existing technology is clearly ahead of current control strategies in biopharma,” said Fran Leira, Executive Director Engineering – Biologics and Sterile Technical Operations at Merck. “This paper is a great tool to close this gap and move microbial control to a new level that will benefit companies and patients.”
The paper addresses the need for a systematic and best practice approach to the assessment and deployment of ARMM. It proposes a nine-step framework and common language that can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMM. These include improved monitoring, assurance and control of biopharmaceutical processes and manufacturing environments, and shortened cycles in the supply chain.
The barriers to adopting ARMM are both real and perceived. They include unclear drivers for application, lack of best practices for validation, capabilities advertised by vendors that do not fully meet the end-user’s specific needs and conjecture that regulators will not support the methods.
The mission of the BioPhorum ARMM team is to remove those barriers to implementation by using its structured framework. This will guide users through the questions they need to ask to ensure a successful project:
- Evaluation, e.g. is it going to work? Is it going to meet our business needs?
- Validation, e.g. does it perform as well as or better than compendial methods?
- Implementation, e.g. how do we implement the method?
Using the paper’s structured approach means it will be easier for senior management to understand and thoroughly evaluate the business case of an ARMM proposal and allow them to filter out those that do not justify an investment.
Subsequent papers to be published by BioPhorum teams in 2020 and 2021 will provide case studies on the application of this framework: alternative/rapid sterility test methods, alternative/rapid adventitious agent detection assays, automated colony counters and bio-fluorescent particle counters.
Looking ahead, there remain many other potential applications for ARMM to ensure and improve product quality, patient safety, data integrity and the efficient delivery of medicines to the patients. This harmonization and collaboration will, however, require a paradigm shift from the current state. The BioPhorum ARMM team is committed to a collaborative approach that will accelerate the adoption of these potentially transformative methods.
At an industry level, the adoption of ARMM is a strategic imperative. With so many different technologies becoming available, the pace of change means that companies need to make decisions about many different applications in a quick and structured way. This BioPhorum paper gives them a way of doing this.