It’s vital to ensure appropriate assessment of molecules at the early research phase is carried out to risk mitigate movement into the development phase. This ensures the best risk of success with minimal usage of resources and finances. This presentation will highlight the procedures for assessing developability and also showcases the challenges associated with administering low concentration biologics.

Metal-induced oxidative instability of antibody and surfactants can potentially impact on the quality, efficacy, and safety of drug products. This work systematically evaluated the impact of transition metals (Fe and Cu) on the stability of antibodies and PS80 in biotherapeutic formulations. The results showed that PS80 degradation is mitigated with increased concentrations of antibody, indicating that acting as an ROS scavenger, antibodies can effectively protect PS80 from oxidation by metal impurities.

This presentation outlines an end-to-end high-throughput workflow for liquid formulation screening. It includes scenario-driven experimental design; digital-enabled sample preparation across multiple liquid handlers; scale-down model of common stressors (e.g., agitation, light); and high-throughput analytical assays. We also detail rigorous data governance—vetting, cleaning, and selecting appropriate datasets—and a holistic, systematic evaluation framework that integrates multimodal results using fit-for-purpose models to inform robust formulation decisions.

During development of masked antibodies at Byondis, increased high-molecular-weight (HMW) species were detected despite earlier optimization efforts. Because platform compatibility is essential for efficient downstream development, two complementary mitigation strategies were implemented to ensure that these antibody formats would align with the established Byondis platform. Three-dimensional charge-based modeling was used to refine molecular features and lower aggregation risk, providing structure-guided insights for improved design. In parallel, extensive formulation screening identified conditions that effectively minimized HMW formation during processing and storage. Both approaches enabled robust development of masked antibody therapeutics.

This talk will discuss strategies to overcome a key hurdle in biopharmaceutical development: creating stable, high-concentration monoclonal antibody (mAb) formulations that remain stable, manufacturable and injectable. Combining advanced characterization techniques such as microrheology (DWS), DLS, microfluidic viscosity (NanovisQ) measurements with AI/ML,  new insights into how pH, salts, and temperature impacts aggregation/viscosity are obtained. These results offer a practical framework for accelerating formulation timelines and improving quality of mAb therapeutics.

Drug product development for small‑molecule generics and biosimilar biologics diverges due to molecular complexity and regulatory expectations. Generics leverage defined chemistry, predictive tools, and BE‑driven prototypes, while biosimilars require deeper analytics, DS–DP understanding, and formulations that preserve structural integrity. This review highlights key challenges and phase‑appropriate strategies—including AI‑enabled modeling, machine‑learning‑driven analytics, platform formulations, and risk‑based similarity assessments—to accelerate development and deliver robust, approvable products.

A novel image-based deep-learning workflow was developed to accurately identify inherent, intrinsic, and extrinsic subvisible particles (SvP) in biologic products. The workflow incorporates transfer-learning feature extraction, ground truth label cleaning via AI similarity search, and modern computer vision models to achieve fast and robust classifications. This comparative, cross-platform study highlights the value of modern object-detection architectures in enhancing SvP identification and reducing dependency on confirmatory tests, thereby improving process understanding within biologics development.

Predicting viscosity is critical for developing high-concentration antibody formulations for subcutaneous delivery, where excessive viscosity can limit injectability. While monoclonal antibodies have been widely studied, multispecific antibodies introduce additional structural complexity that challenges viscosity prediction. We present an integrated multiscale computational workflow combining automated structure generation, all-atom molecular dynamics simulations, and a one-bead-per-domain coarse-grained model. Intramolecular interaction parameters are derived from molecular simulations and incorporated into the coarse-grained framework. Predicted relative viscosities show strong agreement with experimental trends, enabling mechanistic insight and early-stage assessment of viscosity risk for antibody therapeutics.

Effective management of impurities—especially sub-visible and visible particles—is essential to ensuring biologic product quality and regulatory compliance. Particle risks arise from formulation, process variability, and container–closure interactions, requiring early detection and phase-appropriate controls. This presentation outlines a streamlined, risk-based approach to identifying, characterizing, and mitigating particulate matter across development. Key regulatory expectations for particulate control and visual inspection programs will be highlighted, along with practical examples showing how proactive investigation, documentation, and cross-functional decision-making reduce compliance risks and late-stage delays. Attendees will gain actionable strategies to support reliable, inspection-ready biologics manufacturing.