ResourceDrug Discovery & Development
Quality by design planning in ATMPs
9 Oct 2025Unqualified or inconsistent raw materials can derail therapeutic development, triggering revalidation, repeated process performance qualification (PPQ), and costly delays in Phase 2. For biotech and pharma teams, evaluating starting materials is essential to ensure product consistency and regulatory success.
Discover how robust GMP frameworks support raw material assessment for advanced therapies, from cancer cures to treatments for previously untreatable genetic disorders.
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Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.