Table 2.

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

Factors to consider	Early Phase	Late Phase/Commercial
Material and Time	Limited material and tight timeline	Allow more comprehensive development
Lyophilization Site and Capacity	May change between different CMOs and/or different lyophilization units at the same manufacturing site	Selected/known manufacture site and lyophilization unit
Product Knowledge	Limited process development	Good process understanding with comprehensive development experiences
Economic/cost	Less important (only a few runs to support early clinical trials)	Important (repeat runs for larger scale clinical trials and commercial supplies)
Lyophilization cycle	Conservative/Platform and can fit different lyophilization units	Optimized/Efficient/Robust with defined design space for selected lyophilizer unit(s) intended for commercial production