PLANNING AND PREPARATION OF DRUGS AND ACTIVE BIOTECHNOLOGICAL PRINCIPLES
Academic year and teacher
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- Versione italiana
- Academic year
- 2021/2022
- Teacher
- ANNA BALDISSEROTTO
- Credits
- 6
- Curriculum
- Biotecnologie per la salute
- Didactic period
- Secondo Semestre
- SSD
- CHIM/08
Training objectives
- COGNITIVE: The course aims to offer general skills in the field of biotechnological drugs, with particular attention to design and development. The frontal activity will be dedicated to the deepening of specific aspects of biotechnological research, with particular reference to the drug-design process, the identification of therapeutic targets and the design of new biotechnological drugs with the aid of computational methods. In addition, skills related to the development phases, clinical trials, industrial production and marketing of biotechnological drugs will be acquired. OPERATIVE: Knowledge of problems related to the preparation of pharmaceutical products; possibility to see and try some preparation techniques or protocols. Ability to analyze the behavior of bioactives in relation to their structure. BEHAVIORAL:The aim of this discipline is to prepare students for the professional life of a biotechnologist in both the industrial and academic sectors.
Prerequisites
- The student to attend the course of Design and production of drugs and biotechnological assets must possess general preliminary knowledge concerning chemistry, biochemistry, computer science, molecular biology.
Course programme
- Invention and Innovation: how biotechnologies fit into the concept of innovation. Basic research, applied research and radical research. Biotechnology in the pharmaceutical sector in Italy (4 hours). Why do we need new drugs? Subdivision of drugs and definitions. Differences between traditional and biotechnological drugs. Advantages and disadvantages of biotech drugs (4 hours). How a drug is developed. Pharmacology and the scientific method. Birth of modern pharmacology and regulatory bodies. The evolution of drug discovery. Structural parameters of a molecule (6 hours). How to design and develop a drug. Analysis of the drug discovery process: identification of the target, identification of the hit compound, study of the active molecule in order to realize derivatives with a more defined activity profile, metabolism and toxicity (lead compounds), pre-clinical studies and clinical studies. Particular attention will be paid to the design methods that provide for computational procedures: molecular docking, QSAR, homology modeling (12 hours). General characteristics of bio-industrial processes and main components and operations of the industrial biological process. Recombinant DNA technique. Post-translational modifications of proteins. Systems of expression and importance of the production process. Cultivation systems and cultivation mediums. Reactors and control systems. Cell cultures: batch, continuous, fed-batch, perfusion and solid layer. Classification of bioreactors. Contaminants and their removal. Downstream processing and basic operations. Leachables. Concentration step and reverse strategy. Design and scale-up. Phases of downstream processing: Cell disruption, removal of insolubles. Filtration, centrifugation, precipitation. Coagulation and flocculation. Product purification: chromatography. Problems to consider of protein production and purification. Product polishing. Crystallization, drying, freeze-drying. Aspects that define the quality of biological and biotechnological drugs. Reproducibility of finished product batches. Control of the production process and the finished product. Impact of quality on safety and efficacy. Analysis of MCB and WCB cell banks. Comparability guideline and comparability exercise. Monoclonal antibodies: hybridoma and phage display technique. Evolution of monoclonal antibodies, therapeutic antibodies and mechanism of action. Characteristics of monoclonal antibody conjugates. Conjugates of monoclonal antibodies and conjugation strategies (14 hours). Practical laboratory exercises: Preparation of formulations based on biotechnological derivatives: control of short-term stability through evaluation of the chemical-physical parameters (pH and viscosity) and by analytical HPLC (12 hours).
Didactic methods
- Theoretical and practical lessons.
Learning assessment procedures
- Oral exam with project production. The exam will be an oral examination of 3-4 questions related to the topics covered in class and to the activity carried out in the laboratory. The student will take to the exam an individual work project (power point or pdf presentation of a maximum of ten slides) on a biotech drug of your choice, which will be the starting point of the oral discussion.
Reference texts
- Slides of the lessons and additional bibliographic resources provided by the teacher.
For further information, the student can consult:
Foye’s Principi di Chimica Farmaceutica
Ristampa riveduta e corretta
THOMAS L. LEMKE - DAVID A. WILLIAMS - FOYE 2013
Medicinal Chemistry, the processes of drug discovery
Erland Stevens, Piccin, 2015
Compendio di Biotecnologie Farmaceutiche
Maria Luisa Calabrò, EDISES, 2012
