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The Spontaneous Infection: Did you leave the back door to your cultivation suite open?

The Spontaneous Infection: Did you leave the back door to your cultivation suite open?

In Shared clean-in-place systems: To share or not to share? and How much harm can a single droplet do? Considerations for a viral inactivation step, BioPhorum’s Drug Substance Closed Systems in CNC workstream addressed viral segregation of manufacturing steps relating to the purification process. In this follow-up paper, published by BioProcess International, the workstream looks more closely at viral contamination risks related to perhaps the...

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Why applying environmental monitoring best practices will reap benefits for all

Why applying environmental monitoring best practices will reap benefits for all

Environmental monitoring (EM) programs are an effective tool in assessing the state of control in classified manufacturing areas. They are a vital part of the quality system in all modern drug production facilities and are scrutinized by regulatory agencies. However, designing an EM program is a relatively complex task; facilities vary considerably, there is inadequate specific guidance on how to design one and no single standard risk...

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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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BioPhorum’s revised and improved guidance on single-use change notifications

BioPhorum’s revised and improved guidance on single-use change notifications

Changes to critical, complex systems in our regulated environments must be 100% right. This was recognized by the single-use industry and key customers some five years ago and resulted in a number of papers and much better alignment to a standard language and ways of working around single-use system change controls. However, there is always room for improvement and greater alignment in the industry, and the collective learnings have now been...

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How to assess EHS risks for commercial-scale CGT manufacture

How to assess EHS risks for commercial-scale CGT manufacture

The rapidly expanding field of cell and gene therapies (CGT) has the potential to revolutionize curative treatments. However, among the many hurdles ahead are that occupational health and safety guidelines for the manufacture of CGT products have been lacking and there is no clear framework for considering risks for operators when working at a commercial scale. The result is that there is no ‘universal’ biosafety risk assessment template for...

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PUPSIT: identifying risks and preventive controls

PUPSIT: identifying risks and preventive controls

Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while it is recommended by regulatory bodies, it may compromise downstream sterility and it is expensive to mitigate these risks. To help clarify industry thinking, the Sterile Filtration Quality Risk Management (SFQRM) Consortium is sharing its knowledge and expertise on...

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How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation

How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation

How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while some regulatory bodies are asserting its need, it may compromise downstream sterility and it is expensive to mitigate these risks. To help clarify industry...

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Start your procurement journey with the right approach to knowledge management

Start your procurement journey with the right approach to knowledge management

Many IT systems allow information capture, storage and retrieval. And with the advent of advanced analytics and ‘big data’, more and more data can now be connected. However, the way data is transformed into information and then knowledge requires careful consideration. This is why the BioPhorum Knowledge Management Workstream has published a User Requirements Specification for a Knowledge Management System for Use in a Biopharmaceutical Setting...

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Extractables: New streamlined protocol and industry portal

Extractables: New streamlined protocol and industry portal

Extractables: New streamlined protocol and industry portal The BioPhorum Extractables Workstream has made great strides in the world of extractables and is excited to announce an updated, streamlined protocol and a fantastic new web portal. The protocol, Extractables Testing of Polymeric Single-use Components used in Biopharmaceutical Manufacturing, is based on an extensive scientific review and will reduce costs and focus people on the...

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Is your digital manufacturing plant cyber resilient?

Is your digital manufacturing plant cyber resilient?

As the maturity of digital manufacturing plants grows, so does the risk of a cybersecurity or other digital incident. A successful phishing attack or a data center cooling failure, as examples, could adversely impact manufacturing operations and potentially take a facility offline for hours, days or even longer. So the ability of a plant to minimize the risk of a digital disaster, and quickly restore operations if one occurs, is a vital...

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