Raw materials strategy

Biopharmaceutical companies rely on a dependable supply of raw materials to ensure they can continue to supply patients with often life-saving medicines. Significant changes in industry’s research areas (e.g., oncology) will continue to impact clinical and commercial supply strategies and overall market demand for raw materials over the next few years.

Covid-19 is perhaps one of the clearest examples of the interdependency of pharmaceutical supply chains, demonstrating the challenges of relying on single suppliers and the difficulty of finding flexibility around substituting raw materials.

This document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry. It also encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs.

In addition, it highlights the importance of implementing industry solutions and directs readers to BioPhorum Raw Materials Program publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links. They also provide education and information for biomanufacturers and their suppliers.

The framework contains technical, regulatory, quality, and supply chain considerations and may be of interest to stakeholders working with both new and commercial products, including:

  • Technical leadership teams and their representatives, e.g., CMC development and Manufacturing Science and Technology teams
  • Regulatory leadership teams
  • Quality leadership teams
  • Supplier leadership teams.

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Raw materials strategy July 2022.pdf
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  • Create Date 28th July 2022
  • DOI https://doi.org/10.46220/2022DS002
  • Last Updated