Formulation and lyophilisation
Formulation and lyophilisation: 3 articles from Peptides Info. Handling, storage and laboratory reference.
Lab Freeze-Drying: Tg', Collapse Temperature and the Cycle
How Tg' and the collapse temperature are measured, how they set the product-temperature target, and how shelf temperature and chamber pressure follow from it. A cycle-design procedure for a laboratory freeze-dryer with a parameter table and a run record.
Lyophilisation Excipients: Bulking Agents and Lyoprotectants
What mannitol, glycine, sucrose, trehalose and buffer salts each do in a freeze-dried peptide formulation, how each behaves on freezing and drying, what goes wrong with each, and a procedure for reading excipient content from a label and a certificate of analysis.
Cake Inspection: Collapse, Meltback and Reconstitution Time
A bench procedure for inspecting a lyophilised cake: lighting and background, a defect vocabulary, a 1 to 5 grading scheme, what each defect says about moisture and drying temperature, the timed dissolution test, and the record to keep.