Rising to the rare disease challenge: Key considerations in large-molecule orphan drug development

Whitepaper

Rare diseases present a unique set of challenges within drug development due to small-scale manufacturing, limited time/data, small sample sizes, and costs. Learn how to overcome these challenges with:

Process design decisions for clinical batches across the three stages of validation
Key formulation considerations for sterile dosage forms based on the physical, chemical, and biologic characteristics of the drug substances
Optimal API quantities for preclinical development and phase I studies

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