Bulk drug substances (BDS) often require frozen storage to preserve the integrity of biological material. Cold-chain management is particularly important given recent trends toward increasing globalization and decentralization and diversifying modalities. A secure cold chain is essential for maintaining a product’s critical quality attributes (CQAs) — such as drug product stability, integrity, and purity — and to prevent costly product losses. Scaling Up the Cold Chain Frozen storage at commercial scale presents its own challenges; facilities must be able to…