Division/Committee: [BIOT: Division of Biochemical Technology]

Mechanistic models capable of describing bioseparations have long been available, but only recently their implementation into mainstream biopharmaceutical development has increased. The digital revolution is sweeping through the biopharmaceutical industry, resulting in computational workflows that can be readily integrated with modeling to achieve intelligent and disruptive downstream process development and manufacturing. The need for process intensification, plant design, increased productivity, reduced costs, and bringing products to market faster has further necessitated the use of modeling in all stages of biopharmaceutical development and manufacturing. This session invites speakers from all fields to share their research and case studies in the modeling of bioseparations. In particular, we invite speakers to share their research in and implementation of modeling methods for all modalities (Abs, therapeutic proteins, peptides, viral vectors, mRNA, etc.) and all separation methods (chromatography, filtration, centrifugation, etc.), and multi-step modeling approaches. We also encourage the submission of research involving hybrid modeling approaches such as combined statistical and mechanistic models, models that leverage protein sequence/structure, computational fluid dynamics models, models that utilize developability/manufacturability data, and models based on molecular-scale simulations (fundamental studies, predictive models, or hybrid molecular/mechanistic models). We invite research that addresses key practical considerations for mechanistic models in bioseparations, including minimizing mechanistic modeling hurdles, assessing and improving model accuracy, transferring models as part of tech transfer and scale-up, or using models for regulatory filings, plant design or lifecycle management. Case studies about the implementation of in silico and mechanistic modeling in clinical and commercial manufacturing for (in-)process control, deviation management, process optimization, scale-up, process transfer, real-time lot release, etc., are also encouraged.

John Welsh

Rivanna Bioprocess Solutions LLC

Appearances