Downstream Processing
Chromatographic Separations for Antibody Structures and Drug Conjugates
Complex antibody structures and conjugates represent an increasingly important part of biopharmaceuticals in clinical trials and on the market. They can present unique challenges for chromatography separations in terms of impurity clearance, control of product homogeneity, process consistency and control. For this session, we invite contributions that explore downstream strategies for the wide diversity of established and emergent classes of antibody structures and conjugates, including multispecific antibodies, single-chain variable fragments, antigen-binding fragments, antibody-drug conjugates, radioconjugates, peptide-based therapeutics, Fc-fusions, as well as diverse protein, peptide, and oligonucleotide conjugates. We welcome presentations that range from modeling, developability assessments, early and late-stage process development, to process scale-up and advanced control strategies. Of interest are further case studies that highlight technological innovations and tools that are uniquely enabling for the chromatographic separations of these complex modalities.
Chromatographic Separations Using Novel Stationary Phases and Ligands
The development of novel therapeutic modalities, intensified processing, and continuous biomanufacturing have led to new and unique challenges in downstream bioprocessing. Innovation of novel matrices and ligand formats, 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 oligonucleotides and peptides, antibodies and their derivatives, enzymes, viral vectors, nucleic acids, exosomes and lipid nanoparticles, vaccines, and cells will be considered. The session encourages case studies demonstrating how innovative chromatographic solutions can meet the growing complexity of modern biotherapeutic production.
Mechanistic & Data-Driven Modeling of Bioseparations
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, better control and bringing products to market faster has further necessitated the use of model- and data-driven decision making in all stages of biopharmaceutical development and manufacturing. This session invites speakers to share their research and case studies in the modeling of bioseparations for all modalities (antibodies, therapeutic proteins, peptides, viral vectors, mRNA, etc.) and all separation methods (chromatography, filtration, centrifugation, etc.), as well as steps in the interface between disciplines, e.g. upstream-capture and final purification-drying/formulation. We also encourage the submission of research involving data-driven modeling, hybrid modeling 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 models in bioseparations, including minimizing the experimental cost of calibrating mechanistic models, assessing and improving model accuracy, or using models for regulatory filings, plant design or lifecycle management. Case studies about the implementation of 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.
Membrane and Filtration Based Separations
Membrane separations remain indispensable in downstream processing of monoclonal antibodies, recombinant proteins, vaccines, plasmid DNA, viral vectors, and other complex biologics. Rising modality complexity demands filtration strategies that combine higher selectivity, throughput, and seamless process integration. This session spotlights recent advances in virus filtration, bioburden reduction, ultrafiltration/diafiltration, formulation, buffer exchange, and hybrid or continuous configurations—excluding primary clarification steps.
Topics of particular interest include next-generation modules and novel flow architectures that enable concentration with buffer management in a single pass to achieve mass-transfer objectives. We welcome contributions that deepen fundamental understanding, introduce innovative materials or device designs, and demonstrate scalable, phase-appropriate implementations across clinical and commercial manufacturing. Both experimental studies and modeling approaches (mechanistic, statistical, hybrid, etc.) are encouraged, as are case studies showing effective integration with adjacent unit operations. Collectively, these presentations will illustrate how cutting-edge membrane technologies enable robust, economical, and sustainable bioseparations for today’s—and tomorrow’s—complex biological products.
Separations for Novel Modalities; Viral Vectors, Synthetic Molecules, & Non-Platform Assets
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 and non-viral vectors, virus-like particles, 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 which illustrate the establishment of new approaches for downstream processing of novel therapeutic formats using high throughput and traditional process development, scale-up/down, modeling, process control/optimization, and quality attribute characterization. Submissions on the use of creative separation approaches using novel techniques and their implementation in manufacturing are also strongly encouraged.
Use of High Throughput Methodologies for Process Development & Characterization
As the complexity of biotherapeutic pipelines continues to expand while development timelines continue to compress, the biopharmaceutical industry necessitates more “smart” process development methodologies. Knowledge-driven approaches improve process understanding – facilitating molecular assessment, candidate selection, process development (PD), and characterization (PC) of more efficient and cost-effective downstream processes. These approaches greatly benefit from streamlined, automated data generation for bioseparations processes (e.g., chromatography and filtration). High-throughput (HT) methodologies can meet these demands, reducing time and resource requirements during development and commercialization stages. HT techniques drive rapid exploration and characterization of process design spaces; this enables researchers to quickly screen and evaluate numerous operational designs, accelerating the discovery and optimization of biomanufacturing processes. Importantly, HT techniques improve the efficiency of process model deployment, including mechanistic, data-driven, and hybrid modeling approaches. HT instrumentation enables generation of large, high-quality datasets which facilitate effective calibration and validation of downstream process models. These models then serve as pivotal assets which evolve throughout the product lifecycle. Uniting HT and modeling strategies enables efficient, knowledge-driven PD under accelerated timelines. Case studies highlighting the practical applications and benefits of employing HT methodologies in biopharmaceutical R&D, including monoclonal antibody (mAb) and non-mAb biologics, are invited to submit abstracts.
Novel Harvest Technologies
Harvest and clarification constitute the first steps in the downstream processing of biotherapeutics including monoclonal antibodies, recombinant proteins, vaccines, plasmid DNA, and viral vectors. Traditionally, harvest operations have relied on centrifugation, microfiltration, and depth filtration. However, the evolution of upstream processes such as intensified fed-batch, high cell density perfusion, and continuous manufacturing along with the emergence of novel therapeutic modalities, has driven the need for innovation in harvest and clarification technologies. This session will explore both fundamental and applied aspects of harvest operations, highlighting recent advances such as single-use centrifugation, chromatographic depth filtration, perfusion harvest via alternating tangential flow (ATF) and non-ATF systems, flocculation strategies, and next-generation filtration media. Emphasis will be placed on how these technologies impact process yield, robustness, and critical quality attributes. We welcome abstracts that present experimental insights, case studies, or modeling approaches (mechanistic, statistical, or hybrid) related to primary recovery. Topics of interest include but are not limited to centrifugation (conventional and single use), depth and microfiltration, and harvest pre-treatments such as flocculation.