Using a closure analysis method to reduce CGT contamination risks
Many cell therapy manufacturing processes use open unit manipulations. As a result, they are at risk of potential contam...
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How to avoid the ‘sticking plaster’ approach to knowledge management
Many recognize that knowledge is crucial to the success of every business. The pursuit of knowledge appears to be relentless but often it is not curated, cataloged, retained or shared very well. And the ever-increasing digitization of information just means it is becoming more difficult to manage knowledge in an unplanned way effectively.
Virtual face-to-face meetings extended as CGT celebrates its first successful virtual event
Inaugural virtual face-to-face meeting a success We can confirm that the BioPhorum virtual collaboration model is delivering. On Friday 6 March we decided to relocate CGT05 from Philadelphia to the cloud, and, from Tuesday 10, our team delivered a three-day meeting virtually. As well as sharing case studies, delegates engaged in debates, periodically sharing webcams for a more personal experience. The attendance, representing 26 companies,...
Regulatory compliance: what lessons can be learned?
The person responsible for regulatory compliance (PRRC) is a new role, as defined in the European medical devices and in vitro diagnostic regulations. Interviews carried out by BioPhorum showed that most manufacturers are yet to appoint a PRRC. So, what are the requirements of this role and how should it be performed? New legal requirement The EU Medical Devices Regulation (MDR) (EU 2017/745) and In Vitro Diagnostic Regulation (IVDR) (EU...
Biomanufacturing technology roadmap
BioPhorum has produced a document on the technology and regulatory gaps in the continuous downstream processing of therapeutic proteins. The Continuous Downstream Processing For Biomanufacturing: An Industry Review paper uses a mAb process as a model system and highlights the gaps that are preventing the use of continuous biomanufacturing. It contains a gap analysis of a typical continuous mAb downstream process from primary capture to bulk...
Driving progress in Cell & Gene Therapy
Now with 19 member companies and 183 subject matter experts, the BioPhorum Cell & Gene Therapy (C>) Phorum has made great strides since its formation in 2018. The Phorum has a growing list of goals for the next 12–18 months and the team will use its combined strength to accomplish these. The Phorum aims to support the faster delivery of C> products to market, by lowering business and supply chain risk, and accelerating...
BioPhorum brings together industry leaders
Held in Lausanne, Switzerland, in May, the annual BioPhorum meeting (BioPhorum 2019) attracted some 55 leaders from across the biopharmaceutical industry. With this year’s major theme being the digitalization of biomanufacturing, member companies Boehringer Ingelheim, GSK and Lonza each presented case studies, covering topics such as artificial intelligence in process development, virtual and augmented reality, 3D printing, smart glasses,...
Changing mindsets with a modular approach
“We sense fear of the unknown… yes, the future may appear scary, but the future of our industry needs us to act now.” These are the words of Stefan Merkle, Senior Director Sterility Assurance at Janssen at last year’s Fill Finish Technologies to Reduce Drug Release Times event (FF18). While this comment was in relation to a discussion on whether to pursue in-line monitoring/real-time release (ILM/RTR) technologies, it is equally applicable to...
The BioPhorum and USP collaborative journey to new standards
BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration. To this end, USP is engaging with industry to understand its pain points, its challenges and where there is the potential for new standards. “We have been looking at what additional standards we can develop that aren’t necessarily the traditional USP product-specific standards, but that would...
Agile guidance companion document
The BioPhorum IT Agile workstream has published a supplementary guide – Agile in GxP Environment: companion document, to be used alongside its original guidance to provide more practical advice on how to implement agile in a GxP environment. The Companion is less about ‘what is Agile’ but more ‘how to do it’ in the biopharmaceutical arena.