Biopharmaceutical companies rely on a dependable supply of raw materials to ensure they can produce life-saving medicines for patients.
However, raw material variability is not fully understood between suppliers and manufacturers, which impacts yield and process continuity. There is also a poor understanding of raw material attributes, so the regulatory approach is not optimized, making changes difficult.
Addressing these issues is a huge undertaking and is why BioPhorum has launched its ground-breaking Raw Materials Strategic Framework.
This provides a solution for technical problems around raw materials management and encourages end-users and suppliers to work together to address specific raw material and end-user process needs.
The framework considers technical, regulatory, quality, and supply chain issues and will be of specific interest to stakeholders ranging from technical and supplier leadership teams to regulatory and quality staff.
It is a tool to help maximize the resilience of the raw material supply chain in line with industry standards by setting clear goals and prioritization needs to:
- advance industry knowledge about attributes and impurities – for example, by proactively reviewing raw material performance, and sharing variances.
- create flexibility by making second-sourcing a reality – by using pooled industry product and process knowledge and ‘quality by design’ principles
- optimize limited lab resources – by seeking to harmonize industry standards and analytical methods
- enable predictable raw material performance – by creating a free flow of information between suppliers and end-users.
The framework should be used as a continuous improvement model to support these goals and guide companies and the industry. Working on any of these goals will help advance the others, thus strengthening raw material management in the future.
The more direction industry can give suppliers, the more consistency and control there will be. BioPhorum’s framework aims to solve urgent technical problems in managing raw materials and will support the industry to gain greater knowledge of:
- how raw materials are made
- what they may contain
- and what the performance expectations are.
The framework highlights the importance of implementing industry solutions and directs readers to BioPhorum Raw Materials Program publications. It also contains a case study highlighting the program’s value and how it can make the second sourcing of raw materials easier.
Program members believe there is real potential to build resilience in the global biopharmaceutical supply chain. This includes harmonizing and streamlining industry ways of working, standards, and regulations to optimize the use of limited resources.
To find solutions for how to build resilience and advance supply chain relationships, program members must be aligned on what drives the need for change. They have completed an analysis of the current state and industry drivers and have identified seven areas as key drivers of change for raw materials: patient needs, supplier landscape, knowledge understanding, technology and innovation, geopolitics, and variability.
Increased visibility and understanding of industry’s research, commercial activities, and future direction will help the supplier base respond to industry’s needs more effectively. Without advanced supply chain relationships between life sciences and biopharmaceutical partners, patients may be impacted by quality and/or supply gaps in the sector. BioPhorum’s Raw Materials Strategic Framework will be crucial to the success of these relationships.
An animation summarizing the framework is available on BioPhorum’s Raw Materials resource page.