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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

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Supply Shortages: % of lyophilized and frozen products on the FDA drug shortage list

12 - 15%

None

Now

2040 Goal

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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%

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% of cycles incorporating closed-loop control including automatic endpoint detection

2 - 5%

>75%

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% of lyophilized products manufactured using continuous processing

Unknown

>5%

CO2_footprint.png

Energy use (kW*hr/kg) or CO2 footprint per kg of liquid or final product

Unknown

<1.5 kW*hr/kg

false_rejects.png

% false rejects from automated visual inspection

10 - 25%

<2%

EBR.png

% of products made using electronic batch records for
lyophilization/drying systems

<20%

100%

Renewable_energy.png

# of manufacturing sites using 100% renewable energy

<10%

>50%

Yield.png

% manufacturing yield for lyophilization process (100% rejected due to lyo issues)

Unknown

>95%

Advanced_manufacture.png

% 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

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