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.

Process-related impurities are critical quality attributes which can severely impact product quality and patient safety. A wide range of different problematic HCPs are known which need to be identified, characterized and removed during development. Regulatory guidance documents should be consulted to meet regulatory expectations to avoid delays in market access. An effective HCP control strategy is essential. Regulatory challenges and solutions will be discussed based on relevant case studies.

Emerging masked antibody–drug conjugates (ADCs) introduce increased molecular complexity that can challenge formulation stability and manufacturability. ByonGuard™ is a nanobody‑based masking platform designed to improve tumor selectivity, requiring formulation and process strategies that control aggregation, fragmentation, and colloidal instability. This presentation describes formulation development for a ByonGuard™ masked ADC with emphasis on identifying and mitigating critical stability risks. Process characterization and design‑of‑experiments studies highlighted pH, protein concentration and ionic strength as key drivers of high‑molecular‑weight species formation. These insights guided selection of low‑pH, histidine‑based formulations paired with controlled salt exposure during downstream processing. Biophysical assessment using dynamic light scattering demonstrated improved colloidal stability at mildly acidic pH, while freeze–thaw and forced‑stress studies confirmed acceptable robustness without enhanced degradation. Together, these results illustrate how rational formulation design, integrated with process controls, enables stable delivery and scalable manufacturing of masked ADC modalities.

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.

• Convergence of high-concentration biologics and device innovation
• Patient-centric delivery paradigms beyond self-injection
• 3D printing and additive manufacturing for personalized drug delivery
• Smart and adaptive drug delivery systems
• Translation to clinic: challenges due to system complexity at both technical and regulatory level
  

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.

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.

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.