Table 1.

Lyophilization formulation consideration for early and late phase lyophilized protein drug products.

Factors to consider	Early Phase	Late Phase/Commercial
Material and Time Limitations	Limited material and compressed timeline	Comprehensive formulation development and optimization with less limit on material and time
Product Knowledge	Limited	Good understanding and development experiences
Formulation	Preliminary and/or platform	Optimized formulation for drug stability and meets the requirement for intended administration route. (such as, isotonic, short reconstitution time, low viscosity, elegant cake appearance)
Excipients (that improve cycle efficiency)	Usually not needed for speed to clinical	Important for lyophilization formulation with extended cycle time (e.g. > 3 days)
Stability	2°–8°C storage for clinical supply	≥ 24 month 2°–8°C storage + ≥ 30 days room temperature TOR for commercial distribution, storage stability and shelf life Room temperature stable (ideally)