Four days of lectures, hands-on activities, and transferable skills training delivered by leading academic and industrial experts.
This presentation defines biologics as complex molecules produced only using living systems and includes examples and classification. The main focus of this lecture is on the nature and properties of biologics represented by protein, peptide, and antibody molecules. Data on the physicochemical properties of these molecules and how they affect their stability, efficacy, safety, and performance are provided. Knowledge and understandings will be given into the following: Nature of biologics: size, levels of organization and active configuration; Charge, acidity/basicity (pKa) and Isoelectric Point (pI); Solubility at physiological pH, including approaches that improve or decrease solubility; Conditions of stability of biologics. Physical interactions leading to aggregation and formation of supramolecular complexes: gels, crystals, foams, etc.; Hydrophobicity and hydrophilicity and their impact on Log P and log D.
Learning OutcomesThe lecture will focus in brief on the following aspects of the theme by: outlining the current models of the ligand/drug action; illustrating the main principles of complementarity the protein-ligand/drug interaction; presenting classification of the in silico (computer-aided drug design) methods according to the available information on the protein three-dimensional (3D) structure; describing the thermodynamic aspects and explaining the main types of protein-ligand interactions and how to understand the structural similarity; giving examples of interactions in protein–ligand complexes from PDB.
Learning OutcomesThis training lecture will discuss the rationale behind plasmid design and construction, with an overview of the main solubility and purification tags used in the protein expression and purification workflow. This will include how to use the web-based tools to provide as much information as possible for each protein. We will give an overview and comparison of the three main expression systems, bacterial, insect and mammalian hosts. Why you would choose each one of these, depending on the protein of interest and the downstream applications of the protein. We will also detail some of the optimization experiments required to improve protein expression in the three main expression systems, using examples from our own laboratory.
Learning OutcomesA concise overview of biologics development covering basics of drug development, formulation, analytical testing strategies, and foundational PK/PD concepts. Provides a broad understanding of how biologics progress from early development to regulatory evaluation.
Learning OutcomesThis course covers fundamental steps (lysis, binding, washing, elution) and key techniques like preparative chromatography (affinity, ion-exchange, size-exclusion, hydrophobic interaction) to isolate proteins, commonly using recombinant tags to improve selectivity and efficiency during the purification step. All information concerning the target protein and contaminant properties will help to guide the choice of the main separation technique and experimental conditions to achieve adequate recoveries and high degrees of purity.
Learning OutcomesThis lecture will guide students through the fascinating world of peptides and their expanding role as biological therapeutics. The session will begin by exploring the fundamental properties of peptides and their unique place within the pharmaceutical industry, highlighting why these molecules have become increasingly significant in drug development. You will explore what makes peptides unique and understand how they function inside the human body. You will also learn about the main synthesis techniques used to create peptides, examining both their strengths and challenges. The lecture will highlight why purification and isolation processes are critical for the safety and efficacy of these medicines.
Learning OutcomesThe synergistic integration of cutting-edge biophysical techniques and structural biology methodologies has catalyzed a paradigm shift in contemporary drug discovery, substantially accelerating the trajectory from target identification to clinical candidate nomination across diverse therapeutic modalities. This presentation delineates the strategic convergence of cryo-electron microscopy, artificial intelligence-powered structure prediction algorithms, fragment-based drug design, and high-throughput biophysical characterization platforms into unified discovery engines.
Learning OutcomesDuring this lecture, you will gain a comprehensive overview of Global Pharmaceutical Regulatory Affairs and its importance in the drug development, followed by introduction and maintenance of pharmaceutical products on the market. We will explore the importance of the Common Technical Document (CTD) in creating a standardized way of submitting data to Regulatory Authorities. You will also learn about the vital role of Chemistry, Manufacturing, and Controls (CMC) — a cornerstone for demonstrating and maintaining product safety, efficacy and quality. We will discuss the pharmaceutical product development across clinical phases 1, 2, and 3, guiding you through the initial registration of different types of products.
Learning OutcomesDuring this lecture, you will gain a comprehensive overview of key EU Regulatory frameworks that are engaged during development and Marketing Authorisation. We will begin by exploring the regulatory requirements for Clinical Trial Applications (CTAs) in the EU. Then we will provide an overview of the EU Pediatric Regulation and its role in promoting the generation of high-quality evidence for medicines intended for children. You will also learn about interactions with EU Health Authorities — such as scientific advice and early dialogue mechanisms. The session will then introduce key EU registration pathways, including Facilitated Regulatory Pathways. We will also discuss regulatory exclusivities and development and regulatory considerations specific to vaccines.
Learning Outcomes