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Why this SUS audit guide will reduce industry’s audit burden

In 2020, BioPhorum and Rx-360™ collaborated to develop a pilot program to assess that a Joint Audit Program® model was appropriate for use when auditing suppliers of single-use systems (SUS). The pilot was deemed a success and the model was found to be transferrable across companies with potential benefits around cost, audit burden, and resources for all stakeholders. The results were published in the Joint Audit Program ® – Pilot Program...

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How to introduce new materials – one gate at a time

There are many challenges during drug substance supply in a biopharmaceutical new product introduction (NPI) process. Clinical supply programs are frequently subject to change and therefore supporting drug substance (active pharmaceutical ingredient, API) supply requirements can be extremely variable. Given this unpredictability, key supply issues can arise. In a worst-case scenario, the inability to deliver from any part of a new supply chain...

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Understanding the industry baseline for electronic data exchange implementation across the inbound supply chain

Digitization has transformed both our domestic and commercial lives, and the rapid change we have seen since the introduction of the internet in the 1980s has been coined by Klaus Schwab as ‘the fourth industrial revolution’ in his book of the same name. With the fourth revolution heralding large-scale digital connectivity across artificial intelligence learning systems and networks, the ability to connect digitally and transfer data across...

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Forecasting the future with BioPhorum’s Accuracy Calculator

Generating forecasts remains a thorny problem for many companies who often find the increased demand on the in-bound supply chain a challenge; this has been particularly obvious during the Covid-19 pandemic. BioPhorum’s Forecasting and Demand Planning Toolkit has made great strides in helping biomanufacturers and their suppliers have healthy and open discussions around producing reliable forecasts. Yet, industry often finds this crucial area...

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Industry proposal for a simplified registration process of complex and innovative raw materials in Europe

This paper proposes a solution, applicable to all innovative and complex raw materials, to the challenges the biopharmaceutical industry faces with the registration of complex and innovative raw materials in Europe. The biopharmaceutical industry has designed a direct solution to the issue and identified a way to higher quality regulatory submissions, enhanced knowledge, understanding, control and robustness of its products and processes.

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BioPhorum launch new sustainability phorum

BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....

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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...

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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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