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Trace element variation for chemically defined cell culture media: biopharmaceutical industry requirements and cross-company collaboration to mitigate risks

Trace element variation for chemically defined cell culture media: biopharmaceutical industry requirements and cross-company collaboration to mitigate risks

A proactive risk-based approach to understanding key factors that can introduce product variability is necessary to avoid delays. One such factor identified is elemental impurity variability introduced by cell culture media. Though the impact of the variability will differ, it is important
that both manufacturers and supply partners understand the sources of elemental impurities and perform risk assessments to identify mitigation strategies. Such assessments will allow an understanding of the level of risk, and what steps may be taken to dissipate it. This paper is an effort to drive regulatory bodies, drug manufacturers, supply partners and N-1 suppliers toward a common understanding of the problem and possible solutions that can be taken towards risk mitigation. Though there may not be a single or ideal solution for this issue, a common rational approach can be taken by all parties to understand the impact on their processes and products, to drive identification of mitigation strategies.

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Applying the power of human performance to documentation for successful outcomes

Applying the power of human performance to documentation for successful outcomes

This paper outlines the application of human performance principles to document design and provides guidance for how to implement this in a biopharmaceutical manufacturing environment, with proven results. A more effective system for creating and revising documents—specifically, one that is
aligned with human performance principles—leads to reduced time spent revising documents, improved training and performance, and fewer deviations and CAPAs. By investing the time to understand how work is done and creating documents that align with the needs of the end-user and the realities of how work is performed, we can harness the reliability and promise of a learning organization that is steeped in the principles of human performance.

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A science based approach to qualifying replenishment working cell banks, an industry view

A science based approach to qualifying replenishment working cell banks, an industry view

This paper introduces scientific and technical perspectives and recommendations from industry peers including cell banking technical experts and regulatory representatives from across the globe, representing over 15 pharmaceutical companies. The paper proposes a risk-based scientific approach to qualifying replenishment working cell banks (WCBs) when they are manufactured with, and without, changes. A consistent technical approach to the qualification of replenishment WCBs by incorporating risk-based analysis enables appropriate planning, nimble operations and de-risks product supply for patients by preventing possible delays when replenishing WCBs.

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Guidelines for materials introduction supporting drug substance delivery

Guidelines for materials introduction supporting drug substance delivery

A standard process map providing industry with a set of simple tools containing a structured approach for materials introduction across the supply chain. This paper summarizes a stepwise process that can be used as a guideline for introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company-specific NPI procedures. In addition it is relevant best practice for cell and gene therapy manufacturers.

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Industry proposal for a simplified registration process of complex and innovative raw materials in Europe

Industry proposal for a simplified registration process of complex and innovative raw materials in Europe

This paper proposes a solution, applicable to all innovative and complex raw materials, to the challenges the biopharmaceutical industry faces with the registration of complex and innovative raw materials in Europe. The biopharmaceutical industry has designed a direct solution to the issue and identified a way to higher quality regulatory submissions, enhanced knowledge, understanding, control and robustness of its products and processes.

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Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. This document in the industry response to an agency consultation on draft guidance on ICH Q12. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.

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An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

In this paper, a BioPhorum member team of experts in biologics and vaccines have summarized the current challenges linked to the registration of global products in Russian Federation. This paper describes some of the challenges faced by the industry in relation to current pharmacopoeial requirements for biologics and vaccines and presents a framework of options and activities that would lead to greater alignment with the ICH and the expectations of other regulatory agencies.

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Single-use system audit guide

Single-use system audit guide

The single-use audit guide has been designed to help the auditor and auditee understand the areas of focus in SUS audits, referencing relevant requirements and SUS manufacturing ‘elements’. It is also designed to assist the auditor in reporting their assessment of SUS manufacturers to the end-user. It includes sections on general quality management system areas and products and production processes to consider. It is designed to be applicable to audits of single-use system manufacturers.

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Microbial Control: Detection of Cutibacterium acnes, a high-risk aerotolerant anaerobe recovered in the biopharmaceutical industry

Microbial Control: Detection of Cutibacterium acnes, a high-risk aerotolerant anaerobe recovered in the biopharmaceutical industry

This peer-reviewed paper outlines the risk of aerotolerant anaerobic bacterial contamination during the manufacture of biologic drug substance and the challenges of detection. It examines the issues that manufacturers may consider regarding anaerobic bioburden testing during mammalian cell culture biologics processing, focusing on the detection of aerotolerant anaerobes. It also contains case studies from multiple biopharmaceutical companies, which detected Cutibacterium acnes (C. acnes), the primary anaerobe of concern.

A survey of the BioPhorum Microbial Control Workstream found that more than half of the participants reported contamination events with C. acnes. This survey reported variability in the ability of the compendial microbial enumeration tests to detect C. acnes, thus presenting a challenge for bulk biologics manufacturers. This paper recommends testing conditions designed to increase the likelihood of detecting aerotolerant anaerobe contaminations.

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BioPhorum deliverables mid-year report 2021

BioPhorum deliverables mid-year report 2021

BioPhorum is here to help you make better decisions, faster in your operations. Membership puts you and your team at the center of current debates and helps you to stand shoulder to shoulder with those moving the performance dial on challenges that need a collective voice and a global perspective to resolve. The BioPhorum Deliverables Report is a consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry...

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