We need to develop a high-level approach for managing the transition away from materials of concern as an industry. This must consider the impact on the current patient population supported by processes that may need to change. It must also be mindful that we are all global citizens and want to do the right thing for the future without negatively impacting anyone relying on our biotherapeutics in the present.
Supply Partner
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Industry proposal for a simplified registration process of complex and innovative raw materials in Europe
Oct 2021 | Drug Substance, POI - Drug Substance, Publication, Raw materials, Raw Materials Program, Regulatory Governance, Supply Partner
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.
Extractables: Single use supplier extractable reporting pack
Apr 2020 | Drug Substance, Extractables & Leachables, POI - Drug Substance, Supply Partner
Consistent reporting and presentation of extractable data by suppliers is critical to the fast and reliable assessment of single use systems by users for new solutions. The BioPhorum approach to reporting and presenting extractable data is now the industry standard and adoption of this approach enables all single use suppliers to fit together in an industry ecosystem that effectively supports the continued growth of adoption of single use technologies in biopharmaceutical manufacturing. This pack contains a guide and documents to help single use suppliers and integrators set up their webpages papers and present their extractable data in a way that aligns with the industry standard and extends the ecosystem. Once implemented this approach enables integrators and biomanufacturers to build an extractables profile for a system without needing to transcribe the data, saving time on new designs and minimising the need for expensive custom extractable studies.
Raw material: A holistic approach to raw material risk assessments through industrial collaboration
Sep 2019 | Drug Substance, POI - Drug Substance, Raw materials, Supply Partner
It is impossible to define the raw materials used in the biopharmaceutical industry with a single set of regulatory or compliance criteria. What is considered fit-for-function changes depending on the product attributes and the intended customer. This tool standardizes and structures the risk assessment process, addressing three fundamental questions when determining raw material fit-for-function: What user requirement is the raw material designated to perform? What material attributes are essential to the designated function and what might have unintended consequences? This paper helps improve communication between – and within – manufacturers and suppliers and enables users to make uniform, evidence-based decisions on risks and priorities concerning raw materials. An industry-wide methodology for the resolution of high-impact raw material variability issues.
Change notification: Stakeholder analysis – supply partner
Jul 2019 | Change Notification, POI - Drug Substance
This tool allows users to document key stakeholders who are impacted by the adoption and implementation of the Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems with the purpose of identifying the cross-functional team members required to assist in the implementation and execution of the proposal, as well as the challenges and advantages associated with adoption and implementation.
Single-use, change notification: BioPhorum scorecard survey
May 2019 | Change Notification, Drug Substance, POI - Drug Substance
For change notification practices to realize value the team recognized it is important that a critical mass of biomanufacturer and supply partner companies commit to and implement the same practices as others in the single-use ecosystem. The target was for 15 biomanufacturer companies and seven supply partner companies to implement these practices by the end of 2019, to create critical mass and a working system. The annual scorecard survey is a tool used to monitor the overall effectiveness of change notification for single use systems within the bioprocessing industry. The results from 2018 can be viewed here.
Single-use, change notification: A guide to the classification of changes to SU manufacturing systems
Sep 2018 | Change Notification, Drug Substance, POI - Drug Substance, Supply Partner
The biopharmaceutical industry is increasingly dependent on the use of single use systems to enable manufacturing. These systems are often customised and built from many parts, from a range of component suppliers. Change notification and change management in this complex ecosystem is very difficult unless all suppliers, integrators and users follow the same system and standards for change notification. This guide provides guidance on the classification of changes, helping those implement the best practice establish consistency in their teams and thereby helping them adopt the change notification practices more effectively. Adoption of these practices enables your company to connect more effectively with the global supply chain and avoid the impact and delay from misunderstood change notifications
Single-use, change notification: Guidance and implementation tool kit
Jun 2018 | Change Notification, Drug Substance, POI - Drug Substance, Supply Partner
The biopharmaceutical industry is increasing dependant on the use of single use systems to enable manufacturing. These systems are often customized and built from many parts, from a range of component suppliers. Change notification and change management it this complex ecosystem is very difficult unless all suppliers, integrators and users follow the same system and standards for change notification. This guide provides a definition of best practices that once adopted across the ecosystem will deliver an effective and harmonized change notification system between companies. Specifically it provides an understanding that all companies should categorize changes,standardizes content of a pre-notification and a notification and provides a reporting template, and workflow
Forecasting and supply planning: A best practice guide for the biopharmaceutical supply industry and assessment tool
Apr 2018 | COVID 19, Forecast and Demand Planning, POI - Supply Partner, Supply Partner
Forecasting and demand planning are not well develop or effective integrated between biopharma manufacturers and suppliers in comparison with other industries with complex supply chains. This inhibits the ability of the sector to develop effective and agile supply chains to support rapid growth of products and is a major cause of shortages and the remedial work needed to keep supply chains functioning and products available. Leading end users and suppliers have undertaken considerable work to find solutions to enable biomanufacturers and their suppliers to plan commercial biologic drug manufacturing more effectively. This Forecasting and supply planning: a best practice industry guide, and the companion assessment tool defines the participating biomanufacturers’ and suppliers’ perspectives of the current state of the industry, the roadblocks to success and takes a ‘blue sky vision’ of best practices and the business case for changing the current situation.
In order to define, prioritize and measure improvement opportunities across the industry, the Forecasting and Supply Planning maturity assessment enables organizations to assess their status in relation to industry norms and best practice. More importantly, an assessment’s results provide a blueprint for the strengths and weaknesses that an organization needs to address to elevate its forecasting and supply planning processes.