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Building an essential toolkit for forecasting and demand planning

Building an essential toolkit for forecasting and demand planning

Robust and transparent discussions between biomanufacturers and their suppliers are crucial to producing a strong forecast that both parties will find useful – never more so under the challenges of supply during Covid-19 and the increased demand on the in-bound supply chain. However, BioPhorum benchmarking exercises and surveys have highlighted that industry is often poor at forecasting and demand planning. For example, only around 50% of...

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Smarter auditing with BioPhorum’s joint audit program

Smarter auditing with BioPhorum’s joint audit program

An inefficiency in our industry is where multiple manufacturers individually audit the same supplier in the same year or use a third-party who repeats the same supplier audit for different clients. This creates a heavy burden for the industry. In response, BioPhorum Supply Partner collaboration has worked to understand the value of a joint audit program approach where a third party performs one audit that is available to everybody. The Phorum...

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A new framework for greater alignment for the Russian Pharmacopeia

A new framework for greater alignment for the Russian Pharmacopeia

Russian authorities are making progress in aligning with international pharmaceutical guidelines but, like many other countries, are on a journey towards using these to improve the manufacture of biologics for their home market. Yet, some challenges remain. The Russian Pharmacopeia is a comprehensive reference document that oversees the quality of its pharmaceutical products. However, compared to other countries’ publications, Russian...

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Bringing consistency to vendor testing for harvest clarification solutions

Bringing consistency to vendor testing for harvest clarification solutions

Current manufacturing technologies for cell removal from production-scale bioreactors use one of two options: disc stack centrifugation followed by depth filtration, or direct depth filtration (typically used for bioreactor volumes up to 2kL scale with lower cell densities). Depth filtration approaches have a large footprint, a cumbersome installation process and reach their operational limits with final cell densities of around 50 million...

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Would you like to influence the future of drug device combination products?

Would you like to influence the future of drug device combination products?

Drug device combination products are an increasingly important part of drug life-cycle management. Allied Market Research estimates that the sector will be worth $139bn by 2025, with growth driven by a rise in chronic diseases and increased focus on home-based healthcare. This is an innovative sector with increasingly complex devices being used to deliver drugs – yet there are no harmonized international standards to guide development....

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BioPhorum 2020 highlights

BioPhorum 2020 highlights

In a year unlike any other, BioPhorum takes a look at its achievements over the last few months, celebrating the growth and continued collaboration that helps the global biopharmaceutical industry navigate the challenges it faces. Watch this snapshot of highlights from 2020. https://www.youtube.com/watch?v=DwMUHEoVqUM

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BioPhorum’s 2020 Deliverables Report – 100+ documents and counting

BioPhorum’s 2020 Deliverables Report – 100+ documents and counting

BioPhorum has always been about bringing leaders together, mobilizing communities and creating partnerships to build a powerful vehicle for change. Core to this has been a publication strategy to deliver a library of best practice materials. By bringing members together through our collaborative Phorums, we have now reached a significant milestone – more than 100 industry best practice documents and tools are now available on our website. To...

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How BioPhorum is building the foundations of cyber security best practices in manufacturing

How BioPhorum is building the foundations of cyber security best practices in manufacturing

Higher digital plant maturity levels are characterized by enhanced levels of automation, greater reliance on digital technology and increased use of electronic data. Initiatives such as Industry 4.0, the Industrial Internet of Things (IIOT) and the digital transformation of a plant all drive towards the fully connected plant – yet inherently increase the risk to operations and the likely number of cyber security events. To tackle this problem...

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The Sterile Filtration Quality Risk Management consortium evolves into a community of practice

The Sterile Filtration Quality Risk Management consortium evolves into a community of practice

Questions around the need for a pre-use post-sterilization integrity testing (PUPSIT) strategy have challenged operations and their filtration experts since the inclusion of PUPSIT in Annex 1. Finding the correct answers became increasingly significant with the ongoing debate about the wording and interpretation in the Annex 1 redraft. To respond to specific needs from regulators and end-users, and determine when and why a risk assessment would...

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Aiming high with a User Requirements Specification for CCIT

Aiming high with a User Requirements Specification for CCIT

Container closure integrity testing (CCIT) is critical for ensuring the safety and efficacy of parenteral drug product presentations. Unfortunately, current technology has many deficiencies in testing capability and cannot meet all user needs or test the increasing range of products most companies routinely support. To encourage the development of optimized technologies for CCIT, BioPhorum has written a User requirements specification (URS) for...

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