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 question of material fit.

In our high-stakes, highly regulated environment, as suppliers and manufacturers strive to meet a perpetual tide of new “regulatory standards, the supplier-biomanufacturer relationship can become strained. This new tool standardizes and structures the risk assessment process, thereby improving communication between – and within – manufacturers and suppliers.

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, electronic, point-to-point connections.

But this model can have major time and cost challenges when creating these connections. Updating or changing the links may also be expensive and the effort needed may hamper a company’s ability to quickly respond to changing market demands.

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 that the paper, Best practices in bioassay development to support registration of biopharmaceuticals has been published online in BioTechniques.

“The result is an original and highly relevant paper, which the authors believe will have significant impact on harmonizing biopharmaceutical development practices and allow scientists and regulators to view current thinking in this area,” said lead author of the paper, John R. White, Director, Biopharm Analytical Sciences, Biopharm R&D at GSK.

Last month we announced BioPhorum’s plans to expand our offering into Asia, creating a truly global collaboration and an even stronger vehicle for change.
 
We are delighted to now invite you to the final meeting in our schedule - a showcase event in Tokyo on 5 November. Come along to this complimentary event to hear about the changing nature of biopharmaceutical development and supply chain performance; Japan’s critical role in our global industry; a presentation from Fujifilm Biologics on the increasing importance of CDMOs and more.

The person responsible for regulatory compliance (PRRC) is a new role, as defined in the European medical devices and in vitro diagnostic regulations. Interviews carried out by BioPhorum showed that most manufacturers are yet to appoint a PRRC. So, what are the requirements of this role and how should it be performed?