Metrics and Insights
This section discusses the importance of developing and utilizing specific metrics to measure the effectiveness of initiatives and gather insights for continuous improvement. It highlights the need for data-driven decision-making and the assessment of key performance indicators to track progress and outcomes.
Lyo2040 Key Progress Indicators
Supply Shortages: % of lyophilized and frozen products on the FDA drug shortage list
12 - 15%
None
Now
2040 Goal
Cold Chain: % of approved (parenteral) requiring
-
ultra cold storage (< -25C)
-
frozen storage (-25 to -5C)
-
refrigerated (2-8C)
-
room temperature
10 - 25%
25 - 75%
10 - 40%
5 - 10%
<5%
10 - 50%
25 - 35%
20 - 60%
% of cycles incorporating closed-loop control including automatic endpoint detection
2 - 5%
>75%
% of lyophilized products manufactured using continuous processing
Unknown
>5%
Energy use (kW*hr/kg) or CO2 footprint per kg of liquid or final product
Unknown
<1.5 kW*hr/kg
% false rejects from automated visual inspection
10 - 25%
<2%
% of products made using electronic batch records for
lyophilization/drying systems
<20%
100%
# of manufacturing sites using 100% renewable energy
<10%
>50%
% manufacturing yield for lyophilization process (100% rejected due to lyo issues)
Unknown
>95%
% of products made using Advanced Manufaturing Technologies (AMT) designated by FDA or # of AMT designations for lyophilization / freeze thaw operation
0
25 - 40% or
>10 AMTS