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Bispecific Process Development Stable
Aurigene scaled a bispecific antibody process from stable pool to GMP-ready supply in 10 months, solving low titers, complex downstream steps, and HCP/clipping/homodimer impurities through AMBR15 clone screening, N-1 process intensification, bioreactor scale-up (5L → 1KL SUB), and Protein A optimization. The result: ~2× titer improvement, >99% DS purity, controlled impurities, and ~50% resin cost reduction.
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