Downstream Processing
Chromatographic Separations for Antibody Structures and Drug Conjugates
Sunday 3/17/2024, 8:00-11:00 AM
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 conjugation products addressing challenges in removing undesired conjugation byproducts and/or difficult-to-remove impurities are encouraged.
Use of High Throughput Methodologies for Process Development and Characterization –
Sunday 3/17/2024, 2:00 – 5:00 PM
With diversified therapeutic pipelines, compressed timelines, and an evolving regulatory landscape, there is a critical need for improved process understanding to facilitate process development (PD) and characterization (PC). High throughput methodologies can help to meet this need by reducing time and resource requirements during PD and PC, enabling the acquisition of data necessary for process modeling, and rapidly exploring or characterizing a wide design or operational space. This session calls for abstracts that explore creative approaches to utilize high throughput strategies for PD and PC including but not limited to the use of liquid handling systems, miniature columns, and plate-based screens. Additionally, abstracts focused on the design and interface of high throughput techniques with modeling strategies such as mechanistic or statistical modeling, machine learning, and hybrid modeling are strongly encouraged. Case studies on the use of high throughput strategies to inform PD, PC, or predictive scale-up are also strongly encouraged, especially those non-mAb products.
Membrane Based Separations
Monday 3/18/2024, 8:00-11:00 AM and 2:00 – 5:00 PM
Membrane-based separation techniques are essential for processing of a wide range of biopharmaceutical and biochemical products including monoclonal antibodies, recombinant proteins, vaccines, plasmid DNA, 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, scalability, phase-appropriate considerations, 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.
In silico Modeling of Bioseparations
Tuesday 3/19/2024, 2:00 – 5:00 PM
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, 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 process control, deviation management, process optimization, scale-up, process transfer, real-time lot release, etc., are also encouraged.
Case Studies in Tech Transfer, Scale-Up, and Process Analytical Technologies (PAT)
Tuesday 3/19/2024, 8:00-11:00 AM
The ever-changing landscape of bioprocessing creates new challenges in moving a process from the lab to manufacturing both in clinical and commercial space. Many projects require unique approaches to process fit, technology transfer, scaleup, and process controls or analytics. We seek contributions which explore case studies and technical advances in topics such as scaling of unit operations, especially non-chromatographic unit operations, and the use of fundamental or engineering models to inform process fit and scaling. 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 pathlength technologies, cell and virus analysis tools, and biosensors, among others. As such, we also encourage abstracts which provide insight into these technologies and their use in downstream bioprocessing. Contributions focusing on digital enhancement of current technology transfer approaches to increase speed and enhance data continuity are welcome.
Chromatographic Separations Using Novel Stationary Phases and Approaches
Wednesday 3/20/2024, 8:00-11:00 AM
Advances in novel therapeutic modalities, intensified processing, and continuous manufacturing have led to new and unique challenges in downstream bioprocessing. The development 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 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 in silico modeling. All biological modalities including antibodies and antibody-derivatives, enzymes, recombinant proteins, viral vectors, nucleic acids, exosomes, lipid nanoparticles will be considered.
Novel Separations and Approaches for New Modalities and Viral Vectors
Wednesday 3/20/2024, 2:00 – 5:00 PM
New therapeutic modalities such as viral vectors, cell therapies, RNA are capable of long-term treatment for a wide array of diseases, otherwise not treatable by traditional therapeutics. Recent years have seen a rise in the number of these new modalities, however, significant downstream challenges remain due to factors including the complexity and size of these therapeutics, as well as the growing diversity of these therapies. 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 yields, and evolving regulatory requirements. This session invites abstracts involving the process development, process characterization, or scale-up of downstream processes for non-traditional modalities such as AAVs, lentiviral vectors, extracellular vesicles, stem cells, and RNA. Further, abstracts involving the use of creative separation approaches using novel matrices or techniques are strongly encouraged, as well as the development of platform processes for these new modalities.
Downstream Processing for Non-mAb Modalities and Synthetic Molecules
Thursday 3/21/2024, 8:00-11:00 AM
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, 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, oligonucleotides, carbohydrates, nucleic acids, and vaccines, among others. Various therapeutic formats may have been derived from both recombinant and/or synthetic pathways.