White Paper

Planning For Success In Cell–Based Manufacturing: The Importance Of Quality In Raw Material Selection

Thermo - bioreactors

Selecting high-quality raw materials is essential for the development of a GMP-compliant commercial manufacturing process for cell-based therapies. This is crucial for ensuring product quality, safety, and efficacy, as well as regulatory compliance. However, the complexities of biological therapy development, including the selection of raw materials, can be challenging.

This white paper offers guidance on selecting the appropriate quality raw materials for cell-based manufacturing from the preclinical to commercial phases. It emphasizes the importance of quality assessment throughout the process and reviews the stages of cell culture-based manufacturing, discussing the various raw materials required in each stage. Additionally, the white paper examines product use statements and provides insights on how to use them, along with an assessment of material criticality, to make informed decisions about raw material selection. It also describes ways to ensure the quality of deliverables and support the success of development projects through proper planning for scale-up and regulatory requirements.

To learn more about how to select high-quality raw materials for cell-based manufacturing, download the full white paper.

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