BioPhorum Insights

Annual Report 2021

Welcome to the BioPhorum annual report

BioPhorum Insights looks at the latest industry trends, challenges, and solutions from the members’ perspective. It consists of a wide range of constantly refreshed articles that offer a deeper understanding of topics integral to the industry.

With features including the industry response to the Covid-19 pandemic, and how it has impacted the biopharmaceutical supply chain; how do you support the rapid development of diverse products; addressing gaps in industry alignment and regulatory guidance, the purpose of BioPhorum Insights is to provide members’ experience, insight, and learnings on a platform that is accessible to all.

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While the focus on managing and preventing covid-19 is essential and timely, we also continue to witness and benefit from the results of members’ dedication to understanding and resolving a wide range of industry challenges, together. It is critical that outside of the search for covid-19 related treatments, we continue to advance other, crucially needed pathways. In direct response to the covid-19 pandemic, and to meet member demand, we now hold regular meetings for the global heads of biopharmaceutical manufacturing to discuss issues relevant to them, ranging from personnel issues through to surety of supply of raw materials – including opportunities to discuss strategies of an extended pandemic. We intend to continue to offer a safe space in which leaders can brainstorm solutions that may help their own companies as well as those of other members, acting as a collaborative risk register for the industry. This year’s report focuses on current and emerging industry trends. As we continue to evaluate the best ways to support the adoption and delivery of the First Edition Biomanufacturing Technology Roadmap, in-line monitoring and real-time release (ILM-RTR) was identified as a critical focus for advanced manufacturing therapies. Read more about the potential that can be realized and how you can have an impact. We also hear from members in Asia who have shared their experience of collaboration benefits as we continue to globalize BioPhorum’s vision, making the international consortium even stronger. We discover how BioPhorum and the PDA formed the Sterile Filtration Quality Risk Management (SFQRM) Consortium, which has been working hard to provide objective, unbiased, scientific data to help guide informed decisions about sterile filtration control measures, acting as a best-case scenario of synergy and teamwork. Also, over the past year, interactions with regulatory agencies in both major and emerging markets have resulted in positive outcomes. One example is the recent announcement by Anvisa, revising data requirements for post-approval changes to align with the WHO, and accelerating approval review times. This is just a flavor of what can be found on the following pages. In the last 12 months, member companies have continued to realize the value that can be generated from the publications, guidelines, and best practices that the workstreams have created. When people contribute to solutions in this way, they help to lay the foundation for a more efficient, cost-effective, and higher value industry of the future. Whether you are part of that journey or just benefit from the results of their efforts, we hope that BioPhorum’s involvement continues to support collaboration and acceleration of progress, for the benefit of all. Thank you for reading our Annual Report. I hope that you find it interesting and look forward to your comments.

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The Qualification of Small-Scale Models Workstream addresses the gap in industry alignment and regulatory guidance

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How industry reacting to the Covid 19 pandemic

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Defining technology strategy and leading innovation

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Jun 01 2022

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...
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Jun 01 2022

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...
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Jun 01 2022

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...
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May 31 2022

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...
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May 31 2022

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...
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May 31 2022

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...
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May 04 2022

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...
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May 04 2022

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...
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May 04 2022

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....
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May 04 2022

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...
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