The preparation of media for use in biopharmaceutical processes can be complex and may carry risks that must be identified, assessed, and mitigated to assure consistency of performance and minimize the likelihood of contamination. There are risks throughout the media preparation life cycle, which can be associated with raw material sourcing, preparation, filtration, transfer, storage, and point of use. Without the proper risk mitigation, problems can arise which may ultimately compromise product quality, shut down production, or potentially impact patient safety.
This whitepaper describes considerations for selecting a vendor to support your media preparation workflow and will discuss approaches to minimize variability and de-risk steps, including:
- Sourcing raw materials
- Preparation and mixing
- Storage and transfer