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.

Formulation of classical and next-generation biologics is a challenging area of R&D. Continuous efforts are being made to enhance the shelf life of low- and high-concentration formulations. In this talk, we will deep dive into the different aspects of biologics formulation with a special focus on stability and solubility enhancement. We will present recent advances in this area, especially in excipient space.

A plate-based platform for pre-formulation screening was developed and utilized for early-stage programs under limited material and compressed timelines. The platform combines orthogonal high-throughput stress studies, plate-based concentrating, and innovative analytical/characterization methods to evaluate key attributes including viscosity, stability, and excipient compatibility with minimal material consumption. Beyond enabling more efficient DoE-driven formulation development, the platform also supports early developability screening of research molecules to identify leads with balanced CMC properties.

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.

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.

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.

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.

The rapid development of safe, effective vaccines requires advanced AI-driven tools to streamline formulation and stability assessment. This presentation highlights Bayesian optimization (BO) and machine learning (ML) for formulation development, and Advanced Kinetic Modeling (AKM) for shelf-life prediction. Applied to a fragile lyophilized vaccine, BO confirmed optimal excipients, while AKM accurately predicted two-year stability at 2–8°C, demonstrating robust, data-driven acceleration of vaccine development and stability forecasting.

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.

Developing successful biologics requires a holistic strategy from discovery to commercialization. The nomination of biotherapeutics to CMC development focuses primarily on biological activity, product quality, and stability. The CMC development focuses not only on maximizing product yield and purity but also mitigate manufacturing process impurities to ensure product is safe and stable. This presentation will provide a holistic approach under regulatory compliance to develop and deliver high-quality final drug products to patients.

Lipid nanoparticles delivering mRNA vaccines and therapeutics are effective but inefficient—and heterogeneous in size, shape, and composition. Optimizing them requires single-particle characterization in solution under conditions connected to live cells. I present the CLiC (Convex Lens-induced Confinement) platform for quantitative single-particle imaging, combining label-free interferometric scattering (iSCAT) with multi-channel fluorescence to measure nanoparticle size, mRNA payload, mass, and dynamics in cell-like conditions (Boateng et al., Nano Lett. 2025).

We assessed two laser diffraction techniques-Mastersizer 3000 and Microtrac Sync to study the particle sizing of adsorbed vaccine antigens and adjuvants and compared the performance of both techniques in terms of particle size distribution, resolution and precision. Laser diffraction is a gold standard in biopharmaceuticals industry for size characterization of adsorbed protein antigens, adjuvants and large size aggregates. Microtrac SYNC is an advancement of Mastersizer performing shape and size analysis simultaneously.