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Deviation Management (DMS): Guide to implementing a risk based deviation management system

BioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving.

This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.

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How industry is using technology during the COVID-19 pandemic

The use of technology in its many forms was a recurring theme in BioPhorum’s recent COVID-19 Workforce Protection Survey that was completed by the Senior BioPhorum Connect group, which consists of the leaders and sponsors from the BioPhorum communities. The survey assessed how industry was reacting to COVID-19 to identify and share best practices that would help guide its reaction to the crisis. This article looks at the role of technology in...

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Lab of the Future: Manifesto: digital technology-based capabilities for the quality control (QC) lab of the future

Most quality control labs in biomanufacturing have not yet achieved digital transformation. Lab processes are often manual which is slow and leads to errors and variability as well as long lead times.

Now those traditional ways of working are further challenged by the drive towards inline monitoring and real time release testing, and by new cell and gene therapies with tiny batch sizes and short shelf-lives.

The lab of the future is digital and requires much stronger IT for demand management and process automation, increasingly informed by data analytics and connected to manufacturing operations. This will be enabled by stronger IT security and operations, systems interoperability and governance, and data aggregation using common models, analytics and visualization.

Huge changes in lab personnel skills and culture are needed to work with the systems and the data in these new ways.

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Connected data, cobots and smart scientists: how to create the lab of the future

Many will recognize that the biopharmaceutical quality control (QC) laboratories need much more digital enablement to align with the rest of the manufacturing environment. Issues range from a lack of automation and data not being captured automatically or consistently for advanced analytics. Change and industry collaboration is clearly needed – and a vision of the future has been delivered by BioPhorum through a new paper, Manifesto: Digital...

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How industry is returning to work during the covid-19 pandemic

BioPhorum’s covid-19 Workforce Protection Survey was completed by the Senior BioPhorum Connect group, consisting of leaders and sponsors from the BioPhorum communities. It assessed how industry was reacting to covid-19 to identify and share best practices that would help guide its reaction to the crisis. This article looks at the detail of return to work (RTW) and asks specific questions on how the Senior BioPhorum Connect group is addressing issues such as the RTW criteria, phased approaches and a possible ‘return to lockdown’.

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BioPhorum Connects senior leaders as they respond to COVID-19 crisis

Keeping in touch with peers and colleagues has never been more important. Sharing ideas, discussing problems and finding solutions are vital to counter the extraordinary COVID-19 pandemic. For the leaders of development and manufacturing supply chains, the priority has been continuity of supply and workforce protection. The urgency of the situation has led to rapid decision-making, new policy approaches and innovation at a pace that is unusual...

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Cyber security: Digital plant resilience assessment tool

As the maturity of digital manufacturing plants increases, so does the risk of a cybersecurity or other digital incident. A successful phishing attack, for example, could adversely impact manufacturing operations and potentially take a facility offline for hours, days or even longer.  A company’s ability to minimize the risk of a digital disaster in its manufacturing plants, and quickly restore operations if one occurs, is a vital area for investment to ensure delivery of drug products to patients. To do this, biopharmaceutical manufacturers must understand the cyber resilience at their differing plants and how each site fits into the context of their overall business.

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Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing

This revised extractables protocol for polymeric single-use components in biopharmaceutical manufacturing is based on an extensive scientific review and represents the combined opinion of the biopharmaceutical manufacturers and, crucially, the supply chain. It will reduce costs and focus people on the important data points. The protocol provides guidance on the suggested methods for extractables studies, including sample preparation, extraction conditions, recording test-article sampling conditions, and reporting data from the analysis of extracts. Flexibility is built-in, allowing suppliers to alter many study parameters due to restrictions based on the use of SUS, physical form factor, chemical compatibilities, etc.

The new protocol includes significant changes to the 2014 version, including the removal of 5M sodium chloride and 1% Polysorbate 80 as extraction solvents, the elimination of the time-point zero interval, and the elimination of elemental analysis of 50% Ethanol extracts.

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China: Registration of raw materials entering the composition or presentation of biopharmaceuticals

Since 2017, it has been mandatory for suppliers of APIs, excipients and packaging materials to register their material in China on the DMF registration platform. While many agencies ask for details of a component’s quality and its impact on products, the Chinese requirements for ‘high risk’ materials, such as those used in biopharmaceuticals, also ask for historical information that is typically proprietary which many suppliers are reluctant to share. This paper summarizes the requirements for raw materials in other ICH countries and compares these to the Chinese approach. The paper also lists all of the details needed for the Chinese registration of biopharmaceutical products’ raw materials in a single place, to help suppliers register their products into this vast market.

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