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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.
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.
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.
Microbial control: Microbiological control for affinity capture chromatography processing: an industry perspective
May 2018 | Drug Substance
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.
Feb 2017 | Drug Substance
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.
Continued process verification (CPV): A roadmap for the implementation of continued process verification
Apr 2016 | Drug Substance
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.
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