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Biologics Risk Reduction Through Early Phase Analytical Strategy

Abstract: Catalent’s Bio Early Phase Success Package delivers an integrated analytical strategy designed to de-risk biologics development from discovery through IND. With more than 30 years of experience and 300+ programs supported, our scientists apply orthogonal analytical tools—including in silico modeling, predictive stability, and forced degradation studies—to generate high-confidence data packages. Whether assessing developability, defining formulations, or characterizing molecular stability, Catalent provides early insights that accelerate decision-making and streamline CMC readiness.

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