Application Note

Robust By Design: Addressing New Challenges In Bulk Drug Substance Management

Source: Sartorius
4 Feature

The ongoing evolution of technologies, modalities, and regulatory standards within the biopharmaceutical industry is driving biomanufacturers to adapt their frozen storage and shipping solutions.

The first line of defense against cold chain failures is the integrity of freezing containers during storage and shipping. Biopharmaceutical cold chain solutions are moving increasingly towards single-use containers. Freezing containers require careful design, and single-use solutions must be robust enough to resist being compromised by freezing, frozen handling, shipment, and thawing. Demonstrating these capabilities requires confirmation studies, which biomanufacturers may have limited resources to perform.

To overcome this challenge, "robust by design” freezing containers were developed that reduce manual handling of drug substances and minimize risks associated with cryo-concentration and frozen transport. Explore the concept of "robust by design" in addition to reliable, single-use solutions in cold chain management.

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