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Why BioPhorum’s trace element approach will save you time, money and wasted batches

Why BioPhorum’s trace element approach will save you time, money and wasted batches

Drug products can be heavily impacted when raw materials cause variability – anecdotal evidence suggests that batches worth millions of dollars are sometimes discarded due to trace elements coming through the supply chain. Not only does this increase costs and significantly impact production scheduling, but it could delay the manufacture of drugs that may, ultimately, impact patients. Yet, despite these industry-wide issues, there is no...

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New value-add tools to complement BioPhorum’s forecast and demand planning toolkit

New value-add tools to complement BioPhorum’s forecast and demand planning toolkit

Since 2016, BioPhorum has improved forecast and demand planning working practices by helping manufacturers and suppliers achieve a more consistent, confident, and accurate approach that benefits the whole biopharmaceutical manufacturing industry. Ground-breaking deliverables include a maturity assessment tool (which is increasingly being used by biopharma suppliers and manufacturers to measure the current state of their forecasting and...

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Meet the new Supply Partnering & Relationship Management Workstream – do you want to get on board?

Meet the new Supply Partnering & Relationship Management Workstream – do you want to get on board?

The Forecast and Demand Planning Workstream has produced some industry-leading publications, including a Best Practice Guide, a Planning Toolkit, and a Forecast Accuracy Calculator, which have seen over 600 downloads since publication. It has also recently published a high-level optimal process, a RACI responsibility assignment matrix, and a Storyboard with examples of everyday issues to show how the Toolkit could avoid some of these. Yet even...

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Helping you to identify the risks in your line clearance process and do something about them

Helping you to identify the risks in your line clearance process and do something about them

Product and labeling mix-ups can have serious consequences and are some of the main causes of recalls. As a result, manufacturers must ensure that the correct medication and strength are in the right container with the correct labels and instructions for use. GMP rules state there must be measures along the manufacturing chain to confirm that all products are clearly identified with the correct name, ingredients, strength, and batch...

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Tackling the five crucial data integrity challenges in QC labs

Tackling the five crucial data integrity challenges in QC labs

Data integrity is critical to meet current good manufacturing practices and ensure patient safety. In quality control (QC) labs, data is scrutinized during audits as it supports the quality, safety, and efficacy of a product and indicates a facility’s state of control. Most QC labs have been working on the fundamentals of data integrity and have made progress in areas such as digitization and compliance – but there are many challenges ahead....

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Here’s how BioPhorum’s ‘one voice’ is helping industry save $millions in Colombia

Here’s how BioPhorum’s ‘one voice’ is helping industry save $millions in Colombia

Imagine a situation where post-approval changes took 18–24 months to be reviewed. Think about the impact on biomanufacturers who would need staggered timelines for implementing changes across different markets and different products. And their need for complex processes that affect inventories, time, money, resources, security, compliance, etc. This was the picture facing biotherapeutic importers into Colombia because its health agency, INVIMA,...

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Making your extractables data accessible is easy through BioPhorum’s portal

Making your extractables data accessible is easy through BioPhorum’s portal

The BioPhorum Extractables Portal enables suppliers and integrators to make their extractable data easily available to end users. With the unique pressure on the global biopharmaceutical supply chain post-pandemic, as multiple existing products share the same raw materials as those for vaccines, the portal provides a valuable resource to connect biomanufacturers to the correct replacement materials quickly. Habib Horry, Manager of Process...

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BioPhorum is delighted to announce the appointment of Tim Hawkins as Chief Executive Officer.

BioPhorum is delighted to announce the appointment of Tim Hawkins as Chief Executive Officer.

Tim Hawkins – BioPhorum Chief Executive Officer BioPhorum is delighted to announce the appointment of Tim Hawkins as Chief Executive Officer. Tim joined the team in March as BioPhorum continues its successful expansion and growth. Tim will support and lead the next phase of delivering on BioPhorum’s mission to create an environment of collaboration across the biopharmaceutical and devices industries, to accelerate progress for the benefit of...

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What do your key players need from IT systems in your CGT processes?

What do your key players need from IT systems in your CGT processes?

Manufacturing cell and gene therapies (CGTs) usually involve the coordinated efforts of staff in treatment centres, shipping partners, and more than one manufacturing facility. It has become complex because each new therapy seems to define a contrasting way of doing things and has a different way of interacting across various combinations of the same companies. So how can we align processes? And how can we get to a level of digital maturity?...

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Is it possible to do real-time analysis of aggregates in downstream protein solutions?

Is it possible to do real-time analysis of aggregates in downstream protein solutions?

Eighteen BioPhorum Technology Roadmapping Phorum members (eleven end-users and seven supply partners) have joined forces to collaborate on a hands-on downstream proof of concept (POC) project. The practical POC work has just begun at Merck KGaA (Healthcare)’s Corsier-sur-Vevey site in Switzerland and will investigate the real-time analysis of aggregates content in protein solutions during the bind/elute cation exchange step of a mAb process. It...

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