News and Papers

Sep 2019

Development Group

Industry bioassay approach helps to shape the future

In 2018, members of the Development Group Bioassay workstream came together to write a best practices paper on bioassay development. We are[..]

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Sep 2019

Front Page

Logistics collaboration hub: An opportunity for significant time and cost savings

Most biopharmaceutical manufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services, and they are usually[..]

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Sep 2019

Drug Substance

Proactive prioritization: a new tool for assessing raw material risk

The Raw Material Risk Management workstream has launched a new, raw material risk assessment tool aimed at helping industry identify and prioritize[..]

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Aug 2019

Articles

BioPhorum to expand its collaborations in Asia

Last month we announced BioPhorum’s plans to expand our offering into Asia, creating a truly global collaboration and an even stronger vehicle[..]

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Aug 2019

Front Page

Regulatory compliance: what lessons can be learned?

BioPhorum delivery of value from the disposables five-year plan - supplier change notifications for single-use systems

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Jul 2019

Drug Substance

How well can you handle SUS changes?  Take our surveys and see

BioPhorum delivery of value from the disposables five-year plan - supplier change notifications for single-use systems

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Jul 2019

Articles

Join BioPhorum at BioProcess International Events

We have partnered with BioProcess International to deliver you the science, technologies and contacts you need to accelerate your promising biologics towards[..]

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Jul 2019

Drug Substance

Best practice on transport qualification: good distribution practice

Transport validations “were like building a new Eiffel Tower every time,” said Kim Bang Salling, Transport Validation Expert at Novo Nordisk. “The documentation[..]

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Jun 2019

Articles

Sharing ideas on forced degradation

“Forced degradation studies are an important part of the drug lifecycle process as they can inform many aspects of drug development,” said[..]

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Jun 2019

Articles

Removing the roadblocks to continuous biomanufacturing

Continuous downstream processing is increasingly seen as a feasible approach for manufacturing biologics. The industry recognises that it offers advantages over batch-based[..]

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Jun 2019

Articles

Industry leaders discuss the impact of BioPhorum

The BioPhorum Report 2019 is now available. The Report consists of interviews with more than 50 industry leaders and subject matter experts[..]

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Jun 2019

Change Notification

Communications letter templates

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N1C 4AG

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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[...]

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Cell and Gene Therapy Phorum accelerates progress

The BioPhorum Cell & Gene Therapy Phorum has made significant progress since its creation in 2018 – from building networks and sharing knowledge to endorsing[...]

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2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Industry bioassay approach helps to shape the future

In 2018, members of the Development Group Bioassay workstream came together to write a best practices paper on bioassay development. We are delighted to announce[...]

Read More
Sharing ideas on forced degradation

“Forced degradation studies are an important part of the drug lifecycle process as they can inform many aspects of drug development,” said Jennifer Halley, Principal[...]

Read More
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.

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Proactive prioritization: a new tool for assessing raw material risk

The Raw Material Risk Management workstream has launched a new, raw material risk assessment tool aimed at helping industry identify and prioritize around the challenging[...]

Read More
How well can you handle SUS changes?  Take our surveys and see

BioPhorum delivery of value from the disposables five-year plan - supplier change notifications for single-use systems

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Hi-tech ambitions for Fill Finish

The Fill Finish Phorum has recently embarked on a series of exciting and ambitious initiatives, exploring new technologies and processes to enhance the efficiency and[...]

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Companies poised to follow ARMM recommendations

The Advanced and Rapid Microbial Methods (ARMM) team set out a clear case for modernizing Environmental Monitoring (EM) in grade A settings: in summary bio-fluorescent[...]

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How to achieve the ‘Goldilocks’ amount of environmental monitoring

Regulators require a risk-based approach to environmental monitoring (EM)… but they give no clear definition of what “risk-based” actually means. The aim of the Environmental[...]

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Logistics collaboration hub: An opportunity for significant time and cost savings

Most biopharmaceutical manufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services, and they are usually linked using customized,[...]

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The ‘how to’ guide to implementing Agile in GxP

The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received.It described how the use of[...]

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How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

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Supply chain, forecasting and demand planning solutions gain momentum

The relationship between suppliers and manufacturers is one of the most crucial in biopharmaceutical manufacturing. This is especially the case when forecasting and supply planning.[...]

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2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
BioPhorum and Rx-360 pilot a joint audit model for single-use systems

BioPhorum and Rx-360 have agreed a pilot to validate the use of the Joint Audit Model in the single-use systems supply chain.

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Removing the roadblocks to continuous biomanufacturing

Continuous downstream processing is increasingly seen as a feasible approach for manufacturing biologics. The industry recognises that it offers advantages over batch-based processing by:

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Changing mindsets with a modular approach

Historically, manufacturers have used a ‘waterfall’ approach when designing and building their production facilities, sequentially resolving and specifying all aspects up front and in detail[...]

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How do you bring technology roadmapping to life?

You use it to make change happen and that is exactly what the Phorum’s leaders did after the first edition of the Biomanufacturing Technology Roadmaps[...]

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Slicing years off change implementation

As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa)[...]

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BioPhorum Regulatory Interaction: helping to open doors

To implement any change in the biopharmaceutical manufacturing industry it is important to engage with and collaborate with the regulators. Set up two years ago,[...]

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Regulatory compliance: what lessons can be learned?

BioPhorum delivery of value from the disposables five-year plan - supplier change notifications for single-use systems

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Navigating the maze of medical technology regulation: a solo voyage or a team effort?

Medical technology is a global business, generating annual revenues of over $400bn. The sector encompasses a broad range of technologies: from in-vitro diagnostics and diagnostic[...]

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IaaS Cloud webinar recording play back
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New BPIT guidance to align cloud services to regulatory requirements
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Data Integrity and Agile Webinars to support industry response to regulators
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How to validate informatics in CPV programs

The BioPhorum Continued Process Verification (CPV) and Informatics team has published a paper to support a risk-based approach for the validation of informatics systems for[...]

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Continued Process Verification delivering real saving in time and money

More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place.  Thanks to the CPV white[...]

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A roadmap for the implementation of continued process verification

This article provides a roadmap draws on the content of the CPV case study to provide a step-by-step guide in a more accessible form.

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How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

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Digital plant maturity model webinar replay
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Digital Plant Maturity Model workstream to host webinar
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New guidance available on Forecasting and Demand Planning to streamline supply chain performance
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Host cell proteins poster

This poster presented at the BEBPA Conference, San Francisco builds and consolidates the information currently available in the industry for assessing process risk from Host[...]

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Host cell protein risk assessment, an industry approach

Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs.

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BEBPA risk assessment workshop
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