Most biomolecules, owing to their marginal stability in liquid state, susceptibility to microbial
growth, and tendency to foam upon storage/shipment in the liquid state, often require an …

Protein freeze-thawing is frequently used to stabilize and store recombinantly produced
proteins after different unit operations in upstream and downstream processing. However …

Active pharmaceutical ingredient for biotechnology‐based drugs, commonly known as drug
substance (DS), is often stored frozen for longer shelf‐life. Freezing DS enhances stability by …

Regulations mandate that biopharmaceutical product quality be controlled throughout
manufacturing, storage, transportation, and delivery to patients (1). Operations often include …

ABSTRACT A 300-mL stainless steel freeze container was constructed to enable QbD
(Quality by Design)-compliant investigations and the optimization of freezing and thawing …

Many therapeutic proteins have been launched in market or gone into development stages
for their high therapeutic efficacy. The proteins can be developed mainly as liquid or solid …

Freeze-thawing is a common unit operation during the production of protein-based
therapeutics. Bulk protein solutions are often stored in frozen state for extended periods, and …

Commercializing therapeutic proteins involves a series of processes aimed at maintaining
safe and efficient protein drug solutions before final patient administration. Common …

During freeze drying of biologics, a highly viscous freeze concentrate (FC) is formed upon
the initial freezing due to the crystallisation of ice. Protein stability in this freeze concentrated …

During the manufacturing process of biopharmaceutical products, freeze/thaw of protein
solutions are routine operations, allowing product shelf‐life to be extended and providing …