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DNA once is damaged is followed by activation of cell cycle check points, there by delaying the cell cycle progression either to repair or to permanently eliminate the cells by inducing cell death

In parallel, Quality-by-Design and rigorous CMC programs must define and control critical quality attributes, employ orthogonal analytics, and establish stability under ICH conditionswhile planning for scale-up, cold chain, and any device dependencies (e.g., light/ultrasound)

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