rapid microbiology methods

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A clear path to implementing alternative and rapid microbiological methods

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...

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Alternative and rapid micro methods (ARMM): A framework for the evaluation, validation and implementation of alternative and rapid microbiological testing methods

There are now available to the biopharmaceutical industry several alternative and rapid microbiological methods (ARMMs) for the detection and enumeration of microorganisms during testing. Regulatory authorities are encouraging the biopharmaceutical industry to adopt innovative technologies. Together these methods will lead to improved monitoring and assurance of control of biopharmaceutical processes and manufacturing environments, as well as shortened cycle times in the supply chain. This paper addresses the need for a systematic and best practice approach to the evaluation, validation and deployment of these methods. The absence of such best practice has hindered the adoption of ARMMs, resulting in slow adoption. A nine-step framework and common language is described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs.

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In-line monitoring / real-time release testing in biopharmaceutical processes – prioritization and cost benefit analysis

The goals of an effective in-line monitoring and real time release testing (ILM-RTRT) and predictive modelling strategy are to leverage enhanced process understanding, risk mitigation and process control improvement to reduce the reliance on end product testing while improving early detection of catastrophic failure. Additionally, ILM and RTRT will enable cost reductions, product and process consistency and speed to market while enabling continuous improvement. But of the multitude of critical quality attributes and critical process parameters, which should be prioritized first for transition from off-line monitoring to in-line/on-line/at-line monitoring?

This paper not only answers the prioritization question but also provides supporting quantitative business case information along with technology-agnostic User Requirement Specifications (URS) for each of the attributes to serve as a guide for technology suppliers in the development of systems that will meet industry standards for ILM and RTRT.

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Rapid detection of bacteria and viruses: justification, regulation, requirements and technologies – how can industry achieve broad adoption?

One of the main targets for BioPhorum Technology Roadmapping is to reduce the testing times for bacteria (including mycoplasma), fungi and viruses in biological therapeutics from four weeks to just one or two days. The objective of this white paper is to identify industry barriers associated with adoption of alternative rapid microbiology methods (RMM) for the detection of adventitious agents and to understand how that can be best overcome. As such this paper provides an outline of the current methods for sterility, mycoplasma and virus testing in use and their limitations and lead times. Furthermore the paper explores the drivers for change and the main factors preventing the use of alternative RMM for testing to assure sterility and the absence of adventitious agents in the manufacturing process. Finally it recommends approaches that can be used to cost, justify and make adoption of new RMM technologies a reality to address the limitations of current practices.

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Microbial control: Microbiological control for affinity capture chromatography processing: an industry perspective

Due to the potential for microbial colonization, affinity capture chromatography requires robust microbiological control. In this paper the BioPhorum Microbial Control team addresses the microbial risks and controls associated with affinity capture chromatography. Further the paper sets out an approach to improve understanding of the risks for bioburden, and manage these risks through effective controls during the chromatography process so that bioburden issues will be reduced.

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