Manufacturing and Analytical Characterization - Biomolecular

(M0930-08-49) Novel Strategies for Process-Related Impurity Clearance during Biologics Manufacturing

(T0930-09-56) Development of a High Purity, High Productivity Cell Culture Media Additive

(W0930-09-56) Potency Assay Development for Gene Therapy Products – Approaches and Points to Consider in Data Processing

(M0930-09-56) Reliable Sizing of Lipid Nanoparticles in Concentrated Formulations Using Advanced Dynamic Light Scattering

(M0930-09-57) Identification of Isomerization in IgG1 and Its Impact on Potency: Case Study of a Mab Biosimilar

(T0930-09-57) In-Depth Characterization of PS-80 Degradation in Biologics Drug Products by Reversed Phase Liquid Chromatography Coupled with Charge-Reduction High Resolution Mass Spectrometry

(M1030-08-50) Characterizing Protein Aggregation Using Flow Imaging Microscopy with Orthogonal and Complementary Analytical Techniques

(M1030-08-51) Automated In Vitro Population Bioequivalence for Inhaled Products to Meet the FDA Guidance on Budesonide Using Phoenix® WinNonlin®

(W1030-08-52) Advancing Nanocarrier Therapeutic Development with Structural AI Analysis of Cryo-EM Images

(T1030-08-52) Characterization of Host Cell Protein Impurity Coverage by a Process Specific Assay Kit for Its Suitability for Use during Late Phase Manufacturing of an Investigational Therapeutic Fc-Fusion Protein

(T1030-08-55) Biomolecule Characterization Using UV-Vis Spectroscopy: A Focus on Thermal Stability of Nucleic Acids and Proteins

(T1030-09-56) Cellular Uptake Mechanism of Hollow Polydopamine Nanoparticles, Nanosac

(M1030-09-56) Investigating In Vitro Transcription of Host Cell and Plasmid DNA Impurities in Recombinant AAV Drug Substances

(W1030-09-56) Peptide-Based-Solutions to Reduce Undesired Cell Culture Media Chemistry – New Options for Stabilized Media Formulations

(M1030-09-57) Measuring and Controlling Potency of a Targetless Biologic: Study of PEGylated Hemoglobin

(M1130-08-49) Identifying and Characterizing the Effect of Critical Processing Parameters in Double Emulsion Poly(lactic-co-glycolic) Acid Microparticle Fabrication

(M1130-08-50) A Multicomponent Media Analysis Workflow using Triple Quadrupole Mass Spectrometry during Human Primary T cell Culture

(W1130-08-53) Impact of Lyoprotectant Thermal Properties on Batch Heterogeneity through Various Processing Technologies: Annealing vs. Controlled Ice Nucleation

(M1130-09-56) Development of an Industry Ready Cell-Based Potency Method for an Oncolytic Virus Immunotherapy

(W1130-09-56) Investigating Stability of Trastuzumab (Herzuma^®) Undergoing Lyophilization and Freeze-Thaw Stresses

(T1130-09-57) High-Throughput Characterization of Gene Therapy Products by SEC-MAL

(M1130-09-57) Revisiting UV Spectroscopy for Real-Time Monitoring of Reversible Protein Unfolding

(T1230-08-49) Addressing the Challenges of Industrial Manufacturing of Lipid-Based Complex Injectables: Fine-Tuning of Membrane Fluidity Using Quality-by-Design as a Tool to Enhance Process Effectiveness

(T1230-08-52) LC and LCMS Solutions for Sample Preparation, and Data Analytics to Advance Oligonucleotide Therapy Development

(T1230-09-56) Encapsulation of Low Molecular Weight Chemokines via Single Emulsion Technique

(M1230-09-57) A Workflow for Purity Determination, Intact Mass Measurement, and MS/MS Sequencing of Oligonucleotide Impurities Detected in Synthetic Oligonucleotides

(M1230-09-58) Photo-Stability of Peptides Exposed to LED, Fluorescent or UV Light in Liquid and Solid Formulations

(T1330-08-49) Continuous Processing of Liposomal Nanoparticles as Potential Reference Materials for Drug Product Development

(M1330-08-49) CryoTEM Characterization of Vaccine Materials in Development

(T1330-09-56) In-Cell ELISA Assays to Assess Drug Relative Potency Using the Cytation Imaging Reader for Sample Analysis

(M1330-09-56) Lipid Nanoparticle Impurity Monitoring Using Single Quadrupole Mass Detection for Regulated Environments

(M1330-09-57) Unveiling the Impact of Surface Chemistry on Adsorption of a Therapeutic Monoclonal Antibody Using a Quartz Crystal Microbalance

(M1430-09-56) A Model-Based and Quality-by-Design Compatible Lyophilization Cycle Development Strategy for Biopharmaceuticals

(T1430-09-56) Using Experimentally Validated ML Modeling to Predict the Thawing Time of Biologics During Large Scale Freeze-Thawing Cycles

(M1430-09-57) Using Enzymes to Accelerate PS80 Degradation and Elucidate Mechanistic Impacts of PS80 Degradants on Protein Stability via Thermal- and Agitation-Induced Aggregation

(T1530-08-49) Capillary Mediated Vitrification (CMV) is a User-Friendly Alternative to Lyophilization for the Production of Thermostable Bio-molecules

(T1530-08-53) The Effects of Aberrant Trisulfide Bond Formation in Therapeutic Proteins for Product Quality and Comparative Analytical Assessments

(T1530-09-56) Points to Consider in the Development of Activity and Potency Assays for Enzyme Biotherapeutics

(M1530-09-57) Combining Machine Learning and Backgrounded Membrane Imaging: A Case Study in Comparing and Classifying Different Types of Biopharmaceutically Relevant Particles

(M1530-09-58) Critical Manufacturing Parameters and Their Impacts on the Product Attributes of Bupivacaine Multivesicular Liposomal Formulation (Exparel^®)

(T1130-08-50) Highly Protein-Loaded Melt Extrudates Produced by Small-Scale Ram and Twin-Screw Extrusion - Evaluation of Extrusion Process Design on Protein Integrity by Experimental and Numerical Approaches