Container–closure integrity (CCI) is a vital patient-safety and product-efficacy aspect of parenteral biopharmaceuticals. The challenge is how to identify, qualify and maintain the appropriate methods to ensure CCI’s role in providing patient and regulatory confidence in these medicines. To describe an overarching approach to CCI and BioPhorum’s work in this area, Scott Ewan has written an article called A Holistic Approach to Container–Closure...
Automation is often on the critical path for facility build and reconfiguration projects. It has many benefits – such as increased consistency of operation and safety of personnel – but integration is often bespoke, and the cost and time of customization, connection and validation need to be carefully considered. Integrating key pieces of processing equipment through a ‘plug-and-play’ approach would greatly reduce project timelines and risks....
During the covid-19 pandemic, it is even more important that we connect, share information and help each other meet the unique challenges faced by our industry. The Senior BioPhorum Connect group – consisting of the leaders and sponsors from the BioPhorum communities – has been meeting online since April to discuss and adapt their responses to the pandemic. To assess the measures taken across the industry, BioPhorum recently ran a covid-19...
Driven by the ever-increasing need to reduce product development lead times and the opportunities to exploit new technologies in development, BioPhorum Development Group (DG) has taken a detailed look at its portfolio of work and the work of its sponsors. This allowed it to reflect on where and how member companies are engaged. This was an important task and a very successful one and the Phorum is already seeing the impact in everything from...
Excellence has always been at the heart of everything we do – from holding face-to-face meetings to publishing technical papers. Yet we are always looking to improve, which is why BioPhorum has launched a peer review process that will help make its papers even more robust and trustworthy. “The peer review process is designed to rigorously check a document before it is published,” said Emma Howlett, BioPhorum’s Publications Lead, who is heading...
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...
Cell and gene therapies (CGT) are changing the treatment landscape for many diseases and, with each new headline, patients are putting their hope in the promises that these novel therapies may bring. However, these new approaches come with many challenges that the industry needs to address – from delivery paradigms, to regulatory and supply chain issues. BioPhorum Cell and Gene Therapy has worked hard for two years and is beginning to deliver...
Cell and gene therapy (CGT) is a diverse field, with products and processes as varied as the patients it is trying to treat. As a relatively new group, the Commercialization Workstream in the CGT Phorum began by creating maps of the manufacturing processes for CGT; and what originally started as an internal exercise has grown into a valuable project that could benefit not only member companies but the industry as a whole. Creating the maps...
When testing single-use items, at what point is it appropriate to leverage vendor data, and when does an end user need to carry out testing? Is current regulatory guidance clear and sufficient in the fast moving area of disposables? And wouldn’t it be great if we had a tool that gave the industry a harmonized risk based approach to testing requirements. These are the questions that the BioPhorum Drug Substance TVR team have been addressing and...
In the second half of 2020, BioPhorum Drug Substance will publish a comprehensive set of tools and guidance to help the industry foolproof the transportation, deployment and use of single-use systems. Inspired by the work of Bayer's Berkeley facility, who over many years reduced leak rates from totally unsustainable 40% to a phenomenal 0.04%, the industry package takes the position that single-use systems are complex delicate...
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