Acadia Pharmaceuticals (Acadia)
Modality Solutions’ Full Cold Chain Transport Validation Package Leads to Successful Filing
Acadia Pharmaceuticals (Acadia) is a pharmaceutical company specializing in dementia-related psychoses, negative symptoms of schizophrenia, and Rett syndrome. Acadia embarked on the commercialization of trofinetide, a drug intended for the treatment of Rett syndrome. Lacking experience in cold chain regulatory expectations, they faced challenges in ensuring proper transport validation. In search of unparalleled expertise and the industry leader in cold chain engineering, Acadia turned to Modality Solutions.
Modality Solutions provided Acadia with a comprehensive transport validation package to support its regulatory submission and ensure all their supply chain components are compliant with regulatory standards. This plan included the following:
- Formal risk assessment
- Qualification master plan
- Transport simulation study
- Selection and qualification of thermal packaging
- Design and execution of performance qualification studies
- Summarization of qualification activities
Modality Solutions provided expertise in preparing and managing cold chain transport validation package. Additionally, Modality Solutions established a robust cold chain by selecting and qualifying suitable thermal packaging.
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