Downstream Processing
Eight different topics are being presented throughout nine sessions.
Chromatographic Separation for mAbs
Sunday, August 13 from 8 am – 12 pm PST in Foothill G2
This session hosts contributions focusing on practical and theoretical approaches that advance and optimize antibody purification platforms. Topics include broadening platform applicability across the full range of novel process technologies and modes of chromatographic operation. These topics include but are not limited to: (i) continuous vs. batch modes of purification for process intensification; (ii) scale-down and high-throughput methodologies to evaluate platform fit for antibody candidates; (iii) scale-up/process implementation to enable rapid and robust process transfer to manufacturing facilities; (iv) novel integrative processes (e.g., ATPS, precipitation, and crystallization); (v) utilization of biophysical structure models and large portfolios of data to make process predictions and other “big data” approaches; and (vi) mechanistic and molecular-level characterization of critical separation challenges. These separation challenges could include post-translational modifications (e.g., charge, glycosylation, etc.); antibody-related product variants (e.g., aggregates, clipped forms, and fragments, etc.); and process-related impurities (e.g., difficult-to-remove HCPs, DNA, viruses, and endotoxins, etc.).
Chromatographic Separations Using Novel Stationary Phases and Approaches
Sunday, August 13 from 2 – 6 pm PST in Foothill G2
Recent advances in the biopharmaceutical industry including continuous manufacturing, intensified processes and novel therapeutic modalities have led to new and unique challenges in downstream bioprocessing. Novel stationary phases, technologies, and the creative application of established matrices and chemistries provide opportunities for continued innovation in the purification of biologics. This session calls for abstracts focused on new and enhanced downstream bioprocessing using innovative or disruptive chromatographic technologies and approaches. Topics may cover advances in novel stationary phase matrices, including but not limited to resins, membranes, monoliths and fibers, new ligand chemistries, new modes of operation, and novel interaction mechanisms. The scope may span from process development and optimization, process characterization, high-throughput screening, scale-up, and mechanistic modeling. All biological modalities including antibodies and antibody derivatives, enzymes, recombinant proteins, viral vectors, nucleic acids, exosomes, and lipid nanoparticles will be considered. Case studies in larger-scale implementation including clinical or commercial manufacturing are encouraged.
Chromatographic Separations for Novel Antibody Structures and Drug Conjugates
Monday, August 14 from 8 am – 12 pm PST in Foothill G1
This session calls for papers focused on the downstream processing of novel antibody structures which may include but are not limited to, bispecific antibodies, antibody-drug conjugates (ADC), single-chain variable fragments (scFv), antigen binding fragments (Fab), novel antibody structures, or protein conjugates vaccines. The scope may range from theory/modeling, early-stage screening, early/late-stage development, process scale-up, and/or large-scale manufacturing. The following topics are particularly encouraged and may include HTPD, process optimization, troubleshooting, and/or case studies focused on antibody-based or other recombinant protein conjugates: Investigations for new drug modalities and novel chromatographic ligands (e.g., affinity, HIC, multimodal), Optimization of conjugation chemistry, Purification of conjugation products addressing challenges in removing undesired conjugation byproducts and/or difficult-to-remove impurities, and creative approaches to handling unstable products.
Novel Separations and Approaches for Viral Vectors
Monday, August 14 from 2 – 6 pm PST in Foothill E (hybrid)
Recent advances in the biopharmaceutical industry including continuous manufacturing, intensified processes and novel therapeutic modalities have led to new and unique challenges in downstream bioprocessing. Novel stationary phases, technologies, and the creative application of established matrices and chemistries provide opportunities for continued innovation in the purification of biologics. This session calls for abstracts focused on new and enhanced downstream bioprocessing using innovative or disruptive chromatographic technologies and approaches. Topics may cover advances in novel stationary phase matrices, including but not limited to resins, membranes, monoliths and fibers, new ligand chemistries, new modes of operation, and novel and novel interaction mechanisms. The scope may span from process development and optimization, process characterization, high-throughput screening, scale-up, and mechanistic modeling. All biological modalities including antibodies and antibody derivatives, enzymes, recombinant proteins, viral vectors, nucleic acids, exosomes, and lipid nanoparticles will be considered. Case studies in larger-scale implementation including clinical or commercial manufacturing are encouraged.
Membrane-Based Separations
Session I: Tuesday, August 15 from 8 am – 12 pm PST in Foothill E (hybrid)
Session II: Tuesday, August 15 from 2 – 6 pm PST in Foothill G1
Membrane-based separation techniques are essential for processing of a wide range of biopharmaceutical and biochemical products including small molecules, monoclonal antibodies, vaccines, viral vectors, etc. These techniques are utilized in a wide range of applications in bioprocessing from cell harvest/clarification to virus removal, and product purification, concentration, and buffer exchange. Membrane-based techniques enable and complement many key and novel separations required for purification of biomolecules and are being actively studied and improved in order to meet a higher demand for performance, such as effective harvesting of higher density cell cultures, high-throughput virus filters, high-concentration formulation development, and/or integration of unit operations for continuous/semi-continuous manufacturing. These technologies also play a key role in identifying novel ways of using conventional unit operations to solve both current and future bioprocessing challenges of complex biological products such as use of new/modified membrane material and novel modes of operation. This session seeks to focus on process understanding surrounding membrane operations and to report advances in the development, fundamental understanding, industrial application, and novel implementations of membrane-based unit operations to achieve desired bioseparations. Operations of interest include traditional and novel filtration and membrane processes for clarification, bioburden reduction, virus removal, ultrafiltration and diafiltration, formulation, etc. Both experimental and modeling (mechanistic, statistical, hybrid, etc.) submissions are welcome to this session. Priority will be given to those presentations that provide insights and present approaches of general utility, and for which experimental and/or manufacturing implementations are presented and compared with alternative approaches.
In Silico and Mechanistic Modeling of Bioseparations
Wednesday, August 16 from 8 am – 12 pm PST in Foothill G1
Mechanistic models capable of describing bioseparations have long been available; however, their implementation into mainstream biopharmaceutical development has been limited. This is rapidly changing as the digital revolution is sweeping through the biopharmaceutical industry, resulting in new computational workflows that can be readily integrated with modeling to achieve intelligent and disruptive downstream process development. The need for process intensification, increased productivity, reduced costs, and bringing products to market faster has further necessitated the use of modeling in all stages of biopharmaceutical development. The 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 emerging modeling methods for all modalities (mAbs, therapeutic proteins, peptides, viral vectors, mRNA, etc.) and all separation methods (chromatography, filtration, viral clearance, 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, 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 (resources, time, complexity, or analytical burden), assessing and improving model accuracy, transferring models as part of tech transfer and scale-up, or using models for regulatory filings or lifecycle management. Case studies about the implementation of in silico and mechanistic modeling in clinical and commercial manufacturing for process control, deviation management, process optimization, scale-up, process transfer, real-time lot release, etc., are also encouraged.
Non-Antibody Modalities
Wednesday, August 16 from 2 – 6 pm PST in Foothill G2
Recent advances in first-in-class non-antibody therapeutic biologics have highlighted the benefits and unique challenges associated with the development and manufacturing of these novel therapeutic molecules. Potential applications include controlling global pandemics, addressing previously untreatable conditions, and providing hope for rare genetic disorders. As the diversity of therapeutic pipelines rapidly expands to encompass these novel formats, unique and exciting challenges have emerged in the development, manufacturing, and characterization of these biologics since most lack a templated downstream platform. The diversity in the structures and physiochemical properties of these molecules is driving innovation with processes that include membrane filtration, precipitation, chromatography, phase extraction, differential centrifugation, and affinity technologies. Along with these innovations, this session will discuss: 1.) novel platforms for process development 2.) in-process control strategies, and 3.) strategies for flexible and agile manufacturing of these emerging modalities. We encourage submitting papers on high throughput process development, scale up/down, modeling, process control/optimization, and quality attribute characterization to further establish new approaches for downstream processing of novel therapeutic formats including virus-like particles (VLPs), enzyme therapy products, engineered peptides, carbohydrates, nucleic acids, vaccines, and gene therapy products, among others.
Case Studies in Tech Transfer, Scaleup, and Bioanalytical Process Analytical Technologies (PAT)
Thursday, August 17 from 8 am – 12 pm PST in Foothill G1
The ever-changing landscape of bioprocessing creates new challenges in moving a process from the lab to manufacturing. Many projects require unique approaches to technology transfer, scaleup, and process controls or analytics; conversely, new developments in these fields offer opportunities for improvement throughout the downstream process. We seek abstracts that explore case studies and technical advances in these topics. Scaling of unit operations, especially non-chromatographic unit operations, and the use of fundamental or engineering models to inform process scaling are of interest. Examples of downstream process challenges which require the implementation of novel technologies, controls, or operational strategies in manufacturing are also welcome. The future of bioprocessing will require new process analytical technologies using Raman, fluorescence or infrared spectroscopy, particle imaging, variable path length technologies, cell and virus analysis tools, and biosensors, among others. As such, we also encourage abstracts that provide insight into these technologies and their use in downstream bioprocessing.