ILM and RTR

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Avoiding the rabbit holes: how to develop successful ILM-RTRT strategies

Reducing the time-to-release for drug product is a key goal of the industry as it can lower production costs and accelerate speed-to-market. This is why BioPhorum has completed a significant piece of work on the development of in-line monitoring technologies, which are fundamental enablers of real-time product release. The result is a new and extensive white paper, In-line Monitoring/Real-Time Release Testing in Biopharmaceutical Processes –...

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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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Delivering globally on in-line monitoring and real-time release

BioPhorum is increasing its focus on delivering against strategic goals of member companies as outlined in the BioPhorum Biomanufacturing Technology Roadmap. The first step in achieving this is to form a team with a cross-Phorum focus to implement these technologies – the ILM/RTR Adoption team. The team will look at the ongoing work and opportunities to collaborate on environmental, organizational and technical factors that can be most readily addressed at industry level.

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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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Environmental monitoring (EM): harmonized risk-based approach to selecting monitoring points and defining monitoring plans

Environmental monitoring (EM) is a fundamental control for the biopharmaceutical industry yet available guidance is quite general and open to significantly differing interpretation. This makes the full justification of sampling plans challenging in the face of regulatory scrutiny and it difficult for organizations to optimize and harmonize controls across plants and networks. Using the heightened requirements in and around grade A areas, a group of industry subject matter experts have written this highly detailed best practice guidance on EM risks assessments and sample location and method planning, to provide clarity on how to monitor and control our manufacturing environments. This is the first such detailed standard and will be the basis for consistent application of current best practice; thereby minimizing the risk of regulatory scrutiny and non-compliance, supporting business continuity while reducing unnecessary monitoring to a minimum

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Environmental monitoring (EM): Risk assessment template

This Excel spreadsheet tool compliments the guidance document ‘Environmental monitoring: harmonized risk-based approach to selecting monitoring points and defining monitoring plans’. This allows the user to assess a room against six factors, the amenability of equipment and surfaces to cleaning and sanitization, personnel presence and flow, material flow, proximity to open product or exposed direct product contact material, the need for interventions/operations and their complexity, frequency of intervention and score them

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Continued process verification (CPV) and the validation of informatics systems

Continued process verification (CPV) provides ongoing verification of the performance of a manufacturing process and as such entails the processing of large amounts of data. This paper draws on the experiences of multiple biopharmaceutical manufacturing companies in validating the informatics components of their CPV programs. It sheds light on common issues and provides recommendations and best practices. Computer systems validation is relevant across the lifecycle of a CPV informatics solution. As such the papers scope includes the initial and ongoing activities and deliverables to determine that the solution meets its intended uses and other requirements, for example, data integrity and performance requirements. 

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Container closure (CCI): Dye ingress methods for container-closure integrity testing: An industry position paper

The release of the expanded USP<1207> in 2016 cast doubt over the validity of so-called probabilistic analytical methods, including one the biopharmaceutical industry’s most universal tests – the dye ingress method for container closure integrity

With the dye ingress method ubiquitously used without issue for decades, this paper highlights the continued value and applicability of this and other probabilistic analytical tests. In addition, this paper also describes how any method, whether probabilistic or deterministic, stands or falls on the quality of its development and validation, and not necessarily on the properties of the test itself.

The most important factor is to apply a test method is not how it is labelled, but lies in its development, qualification and whether it meets the need for which it is designed.

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Continued process verification (CPV) of legacy products in the biopharmaceutical industry

This guide to the implementation of continued process verification (CPV) across a portfolio of legacy products complements the foundational document ‘Continued process verification (CPV): An industry position paper with an example plan’ published in 2014. The guide helps biomanufacturers understand how to build efficient and effective plans for legacy products and links to QA systems, provides guidance on implementations across multiple sites and advises on discovery, disclosure and regulatory reporting.

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Biomanufacturing technology roadmap: 1. Executive summary

Current trends in the biopharmaceutical industry, continued market growth, new product groups, cost pressures and the trend towards localized manufacturing exert unprecedented pressure on biomanufacturers to innovate biomanufacturing platforms. To accelerate the industry’s journey, a technology roadmapping process has been established to determine common biomanufacturer needs and to share them openly with supply partners, academics, regulators and government agencies so that directions can be aligned and collaboration enabled. The first edition biomanufacturing technology roadmap, published in 2017 is an initial step, setting a broad vision for the future of biomanufacturing and designed to catalyze industry action. This executive summary brings together the conclusion and recommendations of each part of the roadmap, overview, process technologies, automated facility, modular and mobile, in-line monitoring and real-time release, knowledge management, supply partner management and details the overarching next steps for the industry and this collaboration.

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