Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

← Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders22 sep · 19 min

289: Batch-to-Batch Variability Is a Design Failure, Not the Norm with Sandra Núñez - Part 1

289: Batch-to-Batch Variability Is a Design Failure, Not the Norm with Sandra Núñez - Part 122 sep19 min

Batch-to-batch variability isn’t just a minor annoyance in bioprocess development; it’s often a systemic design flaw hiding in plain sight. That’s the challenge Sandra Núñez, CEO of Amela Biosciences, set out to eliminate. Drawing on 15 years across Lonza, Medinova, Baxalta, and Biogen, she’s engineered a new generation of animal-free, recombinant protein matrices that promise researchers experimental consistency on demand. Topics discussed: The widespread issue of batch-to-batch variability ...