Downstream Processing

Eight different sessions are available for abstract submission.

Chromatographic Separation for Antibody Structures &
Drug Conjugates

This session calls for papers focused on the downstream processing of canonical as well as 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. The scope may range from theory/modeling, developability/manufacturability assessment, early/late stage development, process scale-up, and/or large-scale manufacturing. Topics include broadening platform applicability across the full range of novel process technologies and modes of chromatographic operation. Contributions focusing on process optimization, troubleshooting, and/or case studies focused on antibody-based or other recombinant protein conjugates, investigations for new drug modalities and novel chromatographic optimization of conjugation chemistry, purification of Fabs and/or conjugation products addressing challenges in removing undesired impurities are encouraged.

Use of High Throughput Methodologies for Process Development and Characterization

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.

Membrane and Filtration Based Separations

Membrane-based separation techniques are essential for processing a wide range of biopharmaceutical and biochemical products including monoclonal antibodies, recombinant proteins, vaccines, plasmid DNA, viral vectors, etc. Newer and more complex purification schemes are needed with the emergence of next-generation modalities and other complex biologics. These membrane-based 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. Advances in membrane-based techniques enable and complement many key and novel separations required for purification of biomolecules. Currently, membrane separation techniques are actively studied and improved upon in order to meet a higher demand for performance, such as high-throughput virus filters, high-concentration formulation development, and/or integration of unit operations for continuous/semi-continuous manufacturing. These membrane-based 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 the use of new/modified membrane material and novel modes of operation. This session seeks to focus on process understanding surrounding non-clarification membrane-based unit operations and to report advances in the development, fundamental understanding, industrial application, scalability, phase-appropriate considerations, and novel implementations of those unit operations to achieve desired bioseparations. Excluding membrane-based clarification processes, operations of interest include traditional and novel filtration and membrane processes for bioburden reduction, virus removal, ultrafiltration and diafiltration, formulation, etc. Both experimental and modeling (mechanistic, statistical, hybrid, etc.) submissions are welcome to this session.

In Silico Modeling of Bioseparations

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.

Novel Approaches in Tech Transfer, Scaleup, Process Analytical Technologies (PAT), and Intensified Manufacturing

The ever-changing landscape of the biopharmaceutical industry creates new opportunities and challenges in downstream processing. As a result, many organizations are exploring unique approaches to improve productivity, increase the probability of success in manufacturing, and overcome difficult tech transfers. With these drivers, this session will explore advances in process transfer, scaling of unit operations, intensified manufacturing, and Process Analytical Technology (PAT). We welcome abstracts related to the use of fundamental or engineering models to scale unit operations, digital workflows in process transfer and monitoring, and novel approaches for ensuring process-facility fit. Submissions on bioprocess intensification in the form of continuous, semi-continuous, hybrid or any other level of integrated processing are also encouraged, especially those focusing on closed systems. Finally, we hope to explore new developments in the field of PAT with an emphasis on GMP implementation, real-time control, and associated regulatory challenges. Throughout the topics of this session, case studies and the manufacturing application of novel approaches are of particular interest and will be prioritized in selection.

Chromatographic Separations Using Novel Stationary Phases and Ligands

The development of novel therapeutic modalities, intensified processing, and continuous manufacturing have led to new and unique challenges in downstream bioprocessing. Innovation of novel matrices and ligand chemistries, in addition to creative operational modes, offer important opportunities to meet these downstream challenges. This session calls for abstracts focusing on new and enhanced downstream bioprocessing methods using innovative 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, multicolumn chromatography, and process modeling. All biological modalities including antibodies and their derivatives, enzymes, viral vectors, nucleic acids, exosomes, and lipid nanoparticles will be considered.

Novel Harvest Technologies

Harvest and clarification operations are essential for processing of a wide range of biotherapeutics including monoclonal antibodies, recombinant proteins, vaccines, plasmid DNA, viral vectors, etc. as a first step to purification. Centrifugation, microfiltration and depth filtration are the commonly used solid-liquid separation techniques for recovery of large volume recombinant monoclonal antibodies; however, recent advances in cell culture processes with increased cell density and titer, perfusion and continuous processes, as well as emerging novel modalities has required changes to the primary recovery step. Some of these newer technologies include single-use centrifugation, chromatographic depth filtration, perfusion harvest using alternating tangential flow filtration (ATF) and non-ATF technologies, flocculation and new types of depth and microfiltration technologies. Furthermore, the primary recovery step has emerged as a more critical unit operation that determines process yield as well as some critical quality attributes. This session seeks to focus on process understanding – both fundamentally and practically – around several different primary recovery and harvesting technologies as well as review novel advances in this important field. Operations of interest include (but is not limited to) centrifugation, single-use centrifugation, all kinds of filtration technologies as well as harvest pre-treatment (flocculation). Experimental and modeling (mechanistic, statistical, hybrid) submissions are welcome for this session.

Separations for Novel Modalities, Viral Vectors, and Synthetic Molecules

As the diversity of therapeutic pipelines rapidly expands to encompass novel formats, unique and exciting challenges have emerged in the development, manufacturing, and characterization of biologics. The diversity in the structures and physiochemical properties of these molecules, such as viral vectors, cell therapies, exosomes, novel protein molecules and configurations, synthetic peptides, and RNA, is driving process innovation in membrane filtration, precipitation, extraction, chromatography, centrifugation, and affinity technologies. Additionally, unlike traditional antibody processes, platform processes for these therapies are still in their infancy and significant challenges remain including process scaling, challenging impurity profiles, low product titers and yield, and evolving regulatory requirements. We encourage submitting papers on high throughput and traditional process development,
scale-up/down, modeling, process control/optimization, and quality attribute characterization to further establish new approaches for downstream processing of novel therapeutic format. Submissions on use of creative separation approaches using novel techniques are strongly encouraged.