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Case study: Successful process development, validation and commercial manufacturing of an ADC payload

 

Case Study: Successful process development and manufacturing of an ADC payload from phase 1 to commercial cover

 

The volume and pace of cancer research continues to accelerate, leading to substantial improvements in patient survival and quality of life.

As a result, the increased demand for anticancer drugs has led to significant growth for highly potent active pharmaceutical ingredients (HPAPIs).

However, HPAPIs present specific manufacturing and handling challenges. A unique know-how and dedicated corporate culture is required to safely manufacture HPAPIs, involving highly-skilled employees working in specialized facilities equipped with high-containment technologies.

Innovators often look to outsource HPAPIs, as CDMOs, such as Novasep, have the capabilities and expertise required. 

This new case study describes the successful process development and manufacturing of an ADC payload from clinical to commercial supply. 

 What you will learn:

> How process robustness and characterization lead to 100% compliant batches 
> The value of the operational excellence program put in place to support commercial needs
> The deliverables obtained

 

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