Covid-19

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Why BioPhorum’s control plan is a blueprint for continuous bioprocessing success

BioPhorum’s Continuous downstream processing for biomanufacturing: an industry review published in 2019 outlined the technology and regulatory barriers in the continuous downstream processing of therapeutic proteins. The roadmap received great acclaim, especially because it identified several gaps in the process, including a lack of a control plan for continuous bioprocessing. To fill this gap, BioPhorum has published a technical white paper...

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How to master virtual inspections and audits – learning from experience

In normal conditions, regulatory inspections and audits are conducted on-site, with inspectors viewing operations, talking to staff and reviewing documents to ensure they meet requirements. However, travel and social restrictions due to the Covid-19 pandemic have forced regulatory inspections and audits of affiliates to be conducted remotely. This is a very different way of working as it is much more difficult to view and explain process steps...

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A risk-based blueprint for process control of continuous bioprocessing

This paper gives an overview of an accompanying risk assessment template and acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done.The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach.

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Peer to peer practical guidance on remote inspections and audits

Drawing on their real-world experiences, a group of experts drawn from 28 BioPhorum member companies has provided guidance on the detailed working methods that support a successful remote inspection or audit; for example, how to manage information flows between the inspectors and the site subject matter experts’ team. With the impact of Covid-19 likely to be seen for the foreseeable future, virtual inspections may be required for some time. This guidance will help all stakeholders prepare and to avoid the potential problems of remote inspections and audits.

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How industry is reacting to the Covid-19 pandemic

LONG READHow industry is reacting to the Covid-19 pandemicKeeping in touch with peers and colleagues has never been more important. Following the postponement of meetings such as the annual Executive BioPhorum meeting, coupled with the heightened need for communication between industry leaders, BioPhorum established the Senior BioPhorum Connect – a group for senior leaders to share ideas, discuss problems and find solutions to counter the...

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How do you manage risk in your supply chain?

The biopharmaceutical supply chain is global and complex, and disruptions can quickly have an impact – you only have to look at COVID-19 to see the importance of maintaining surety of supply. So, it is critical that manufacturers, tier 1 suppliers and their sub-tier suppliers understand the risks in their supply base and deploy effective and consistent risk management systems to reduce their exposure to problems. Unfortunately, a range of...

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How industry is meeting FDA expectations on the impact of COVID-19

In June 2020, the US FDA published Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing. It provides guidance for industry on the impact of the COVID-19 pandemic and on its expectations around good manufacturing practices (GMP). A cross-industry BioPhorum team – consisting of 130+ subject-matter experts across 43 member organizations – has now prepared a...

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Has the pandemic ushered in an era of virtual inspections and audits?

Faced with the travel uncertainties caused by the pandemic and a backlog of inspections, remotely conducted health authority inspections and affiliate audits have become a necessity. With appropriate use of technology and after ironing out any initial problems, they could become part of the toolkit of the future.  In response to this growing trend, a BioPhorum project is considering the challenges and opportunities of virtual/remote...

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Covid-19: Reference for COVID-19 viral control strategy in the biological manufacturing industry – industry position on the FDA guidance

This paper provides an in-depth exploration of the characteristics of SARS-CoV-2 (the virus) and COVID-19 (the disease). It also discusses how likely these may impact current control strategies that maintain product quality, safety and efficacy in the biopharmaceutical industry. It covers the areas that need to be assessed by biomanufacturers regarding SARS-CoV-2 risks for their patients, employees and products. Mitigation actions for the risks and associated benefits are also proposed. Just as importantly, it also discusses the areas that do not need to be evaluated – as current control strategies for endogenous and exogenous viruses, standards of work and the GMP framework are appropriate to prevent SARS-CoV-2 impacting on product. This is the case when the characteristics of SARS-CoV-2 do not make it unique when compared to the existing controls in place.

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