Title Pharmaceutical Microbiology Code PY236 now changed to BY226 Level 5 Credit rating 20 credits Pre-requisites Essential Cell Biology and Biochemistry Type Extensive Aims Learning outcomes To provide information about microbial growth and culture necessary for an understanding of microbial properties and behaviour relevant to pharmaceutical and medical microbiology. To illustrate the ways in which micro-organisms are exploited for the purpose of producing or assessing the activity/toxicity of medicinal products. To inculcate the necessary awareness and knowledge of safety related to the handling of micro-organisms. On completion of this module the student should be able to: apply a range of specialized skills to demonstrate the practical ability necessary for the safe handling, identification and enumeration of micro-organisms. analyse and evaluate a cloning strategy for a named gene of pharmaceutical importance, and exercise judgement on the importance of large scale nucleic acid and protein analysis in a pharmaceutical context. exercise judgement on the development of biotechnology-based diagnostic products. Content analyse and demonstrate an understanding of the structure and physiology of a range of different types of micro-organisms. evaluate the means by which micro-organisms can be utilised for the production of medicines. This module comprises 36 hours of lectures, 24 hours of laboratory coursework, supported by 86 hours of guided study. Theory – Lectures Laboratory safety in microbiology. Microbial characteristics and growth: bacterial morphology and staining. Bacterial spores and heat resistance; the importance of spores in pharmacy and medicine. Typical composition and uses of chemically defined and complex media. Methods for cultivation of bacteria and yeasts/moulds. Identification and enumeration of bacteria: selective and enrichment media. Novel diagnostic technologies (e.g. microarrays, VITEK, MALDI-TOFF-MS). Methods for total and viable counts of micro-organisms and their application to pharmaceutical products. Viruses and tissue culture: terminology, virus morphology, classification, characteristics and cultivation methods. Tissue culture methods, media and applications. Mycology: characterisation of pharmaceutically and medically important fungi. Important mycoses, e.g. dermatophyte infections and candidiasis. Microbial growth characteristics, batch culture and in large scale fermentations. Theory of continuous and semicontinuous culture processes and how they may be used to increase yields of secondary metabolites. Commercial production of penicillin and production of high-yielding strains of Penicillium chrysogenum. Biotechnology: introduction to biotechnology: microbial biotransformations; types of products which can be produced by micro-organisms. Microbial transformation of steroids. Cloning strategies for genes of pharmaceutical importance; gene cloning and gene therapy; industrially relevant cloning strategies; downstream processing, examples of successful cloning programmes. Impact of DNA chips, genomic and proteomic technologies on pharmaceutical biotechnology and novel diagnostic products; impact of high-throughput DNA sequencing. Novel antibody production technologies, hybrid, single domain, minimum binding unit, humanized and genetically engineered antibodies and their potential applications. Advantages as targeting moieties. Phage display libraries as production factories. Cell based biotechnologies, plant and animal cell culture techniques; use of mammalian cell lines in industry; tissue engineering. Coursework (24 hours) The coursework programme may include the following manipulative laboratory exercises. 1. 2. 3. 4. 5. 6. Sources of microbial contamination. Principles of microbial enumeration. Pharmacopoeial methods for the detection of specified organisms. Bacterial endospores; germination and heat resistance. DNA plasmid extraction and restriction/RT-PCR with CAL package. Computer based biotechnology exercise Guided study Students are required to read and learn certain items in advance of laboratory classes and to complete lecture materials. These materials are clearly set out in the laboratory schedules and can be examined by means of question sheets during the course of the laboratory session. For examples, students are required to read and complete identification tables prior the laboratory class on Pharmacopoeial methods for the detection of specified organisms. Further aspects of the theory syllabus which students will be required to study on their own initiative will be detailed on Student Central. Teaching and learning strategies A number of different teaching and learning strategies will be employed in the delivery of this module, including formal lectures (88 hrs), manipulative laboratory exercises (24 hrs), guided study (86 hrs) and independent study and assessment (66 hours). Learning support Texts Hugo and Russell’s Pharmaceutical Microbiology (7th ed, 2004), SP Denyer, NA Hodges and S Gorman, Blackwell Science. Pharmaceutics: the Science of Dosage Form Design. Aulton, ME (2nd ed, 2002) Churchill Livingstone. Collins and Lyne’s Microbiological Methods, Collins, CH, Lyne, PM, Grange, JM and Falkinham JO (8th ed, 2004) Arnold. Microbial Biotechnology: Fundamentals of Applied Microbiology, Glazer, AN and Nikaido, H (1995) Freeman. Specific readings from Trends in Biotechnology, Trends in Genetics and Trends in Immunology (the list of reading material will be placed on the Studentcentral and appropriate copies placed on desk loan in the library). Assessment This unit of study will be assessed by: continuous assessment of manipulative laboratory exercises (40%), one unseen phase test of 1 hour (40%) including MCQs and short questions and one unseen phase test of 40 minutes (20%) including MCQs and short questions. There will be a threshold of 35% for the manipulative laboratory exercises and of 35% for the aggregated phase tests. Brief description of module This module builds in part upon the information contained in the Foundation Biology module and gives students a more in-depth understanding of the structure and function of micro-organisms and the ways in which they can be exploited for clinical benefit. It also contains features of microbiology which, traditionally, are of practical interest and concern in pharmacy (i.e. the means by which microbial growth can be restricted or prevented). Finally it seeks to provide the student with an insight into the current and potential applications of the so-called 'new biology' to the pharmaceutical industry. Area Examination Board MPharm Biological Sciences Module leaders Professor G W Hanlon Semester offered 1 Site where delivered Moulsecoomb Date of first approval January 2003 Date of approval of this version April 2005 Version number 3 Replacement for previous module PY225, PY424 Course(s) for which module is acceptable and status in course MPharm. Compulsory School home School of Pharmacy and Biomolecular Sciences External examiner Professor Chowdrey