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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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Biomanufacturing technology roadmap: 6. In-line monitoring and real time release

This chapter of the First edition Biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective in-line monitoring and real-time release capabilities. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.

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Continued process verification (CPV) signal responses in biopharmaceuticals

This paper describes how signals can be developed and evaluated in support of CPV in the biopharmaceutical industry. Implementation of CPV, in addition to meeting regulatory expectations, can also provide a basis for continuous improvement of production processes and hence greater consistency of product quality and assurance of supply.

CPV involves gathering data related to CQAs and CPPs, as well as analyses that reveal any statistical signals that become evident over time. It is designed to detect variation within specifications. Thus, CPV is about maintaining control within specification and so does not normally lead to a formal investigation. This paper provides several examples of signal response and escalation within the quality system where necessary as a model of a risk-based approach to CPV.

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Continued process verification (CPV): A roadmap for the implementation of continued process verification

In 2014, the members of BioPhorum produced a 100-page continued process verification case study, entitled “Continued process verification (CPV): An industry position paper with an example plan”. This case study captures the thought processes involved in creating a continued process verification plan for a new product in response to the U.S. Food and Drug Administration’s guidance on the subject introduced in 2011. In doing so, it provided the specific example of a plan developed for a new molecular antibody product based on the “A MAb Case Study” that preceded it in 2009. This document provides a roadmap that draws on the content of the continued process verification case study to provide a step-by-step guide in a more accessible form, with reference to a process map of the product life cycle. It could be used as a basis for continued process verification implementation in a number of different scenarios, for a single product and process, a single site, to assist in the sharing of data monitoring responsibilities among sites, and to assist in establishing data monitoring agreements between a customer company and a contract manufacturing organization.

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Continued process verification (CPV): An industry position paper with an example plan

This 100 page guide and case study is a response to US Food and Drug Administration (FDA) 2011 process validation guidance on Stage 3, ‘Process Validation: General Principles and Practices’. It describes the approach commonly referred to as ‘Continued Process Verification’ (CPV). The paper provides guidance on what is CPV, why it is important, and how might it be implemented. It offers specific recommendations on the content of a CPV Plan, along with associated rationale. Produced through a large collaborative industry effort, these recommendations are modeled around a typical cell culture production process for making a fictitious monoclonal antibody product, described in the ‘A-Mab Case Study’.

The paper is a key foundational document which introduces important topics such as an approach to legacy products and the validation of IT systems and their design. These important topics are then addressed in the following documents available from BioPhorum

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