Supply Partner

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BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization

Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control. Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two...

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Single-use: Testing, validation and release (TVR) standards

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...

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Key updates to Brazilian post-approval change requirements and use of Polysorbate 80 in China

The BioPhorum Post-Approval Strategy Team has been working hard in international regulatory environments over recent years and can now share intelligence on some significant breakthroughs in the key markets of Brazil and China. Brazil is planning to reduce its data requirements for post-approval change submissions, which will make it aligned with other ICH countries. While China has issued new monographs for Polysorbate 80, which means that the...

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MedTech considers drug device challenges

Following a positive response to BioPhorum’s proposal for a new collaboration in the combination products space, representatives from eight BioPhorum member companies gathered in early May to agree a plan for developing a MedTech Phorum program. Ten stakeholders joined the kick-off call and brought more than 125 years of combination product experience spanning functions across the full product lifecycle, including device design and engineering,...

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Extractables: Single use supplier extractable reporting pack

Consistent reporting and presentation of extractable data by suppliers is critical to the fast and reliable assessment of single use systems by users for new solutions. The BioPhorum approach to reporting and presenting extractable data is now the industry standard and adoption of this approach enables all single use suppliers to fit together in an industry ecosystem that effectively supports the continued growth of adoption of single use technologies in biopharmaceutical manufacturing. This pack contains a guide and documents to help single use suppliers and integrators set up their webpages papers and present their extractable data in a way that aligns with the industry standard and extends the ecosystem. Once implemented this approach enables integrators and biomanufacturers to build an extractables profile for a system without needing to transcribe the data, saving time on new designs and minimising the need for expensive custom extractable studies.

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Standards and best practices to support trace metal quantitation in cell culture chemically defined media and hydrolysates

In March, Dr Bala Ramanathan, Senior Scientist at Janssen presented the latest views, standards and best practices to Support Trace Metal Quantitation in Cell Culture Chemically Defined Media and Hydrolysates. The webcast (linked above/below) was organized by BioPhorum and USP.   What the webcast covers Many elements such as copper, manganese, zinc, and iron have significant biological relevance, and are well established as key contributors to...

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BioPhorum’s Maturity Assessment Tool gains momentum

Supplier relationship management is one of the most crucial aspects of biopharmaceutical manufacturing and affects everything from lead times and trust to dialogue and inventory management. It has been one of the top priorities for BioPhorum and its collaborative work has seen member companies improve their supply chain communications and processes. For example, a recent BioPhorum articlehighlighted the importance of enhancing the relationship...

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