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Title MICROBIOLOGICAL & BIOTECHNOLOGICAL ASPECTS OFMEDICINE PRODUCTION

Code BY349

Level 6

Credit rating 20 Points

Pre-requisites BY241

Type of module Extensive, Semesters 1 and 2Aims To raise awareness regarding the importance of micro-organisms

as both potential producers and contaminants of medicinalproducts

To provide students with an understanding of the principles andprocedures involved in hygienic manufacture of pharmaceuticalproducts, the use of anti-microbial agents, product sterilisation andpreservation

To introduce students to biotechnology-based pharmaceuticals,both traditional and modern, their development, production andclinical use

Learning

outcomes/objectives

On completion of this module the student should be able to:

1. apply knowledge of the principles and procedures involved inhygienic manufacture of pharmaceutical products, the use of anti-microbial agents, product sterilisation and preservation2. exercise judgement on the development, production and use ofbiotechnology-based pharmaceuticals3. consolidate and extend competence in practical aspectsrelating to the above

Content Theme 1: Principles and processes of pharmaceuticalbiotechnology

Lectures 1 Introduction and overview

Definitions: products of pharmaceutical

biotechnology, biologics, biopharmaceuticals Processes involved in their production

Lecture 2-3 Molecular Biotechnology

Recombinant DNA technology

Vector systemsLecture 3-6 Production and downstream processing of biotech

compounds

Expression systems

Batch culture and large scale fermentations

Plant and animal cell culture systems

Downstream processing & quality controlLecture 7 Formulation and delivery of biotech productsLecture 8 QAA and regulatory issues relating to biotech products

EMEA guidelines on similar biologicalmedicinal products

Practical classes (4h)

1. Restriction digestion of phage lambda DNA

Theme 2: Products of pharmaceutical biotechnology and theiruses

Lecture 1 Introduction to products of pharmaceutical biotechnology

Traditional pharmaceuticals of biological origin

(animal, plant and microbial) Products of molecular biotechnology

Differences between macromolecules and

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small molecule drugsLectures 2-3 Traditional pharmaceuticals of microbial origin

Commerical production of penicillin

Microbial transformation of steroidsLectures 4-8 Recombinant therapeutic proteins

Therapeutic proteins and their uses (Growth

factors, interferons & interleukins, hormones,coagulation factors and thrombolytic agents).Bioassay and biological standards.

Antibody biotechnology

Pharmacokinetics and pharmacodynamics ofpeptide and protein drugs

Immunogenicity of therapeutic proteinsLectures 9-10 Nucleic acid-based biologics

Gene therapy vectors: targets, deliverysystems & safety aspects

DNA-based diagnostics: techniques & practicalissues

Lecture 11 Cell-based biologics Cell therapy

Tissue engineering

Theme 3: Sterilisation and sterility testing

Lecture 1 Introduction to product sterility

Sterile vs non-sterile pharmaceutical products

Pharmacopoeial limits in non-sterile products

Terminal sterilisation vs aseptic manufactureLecture 2 Aseptic manufacture

Categories of products manufacturedaseptically

Design of pharmaceutical clean rooms Environmental monitoring

Lectures 3-4 Kinetics of antimicrobial action

Parameters used in the design and monitoring ofsterilization processes

D, Z and Fo valuesLectures 5-9 Physical methods of sterilisation

Moist heat , Dry heat , Ionising radiation, Gaseous,Filtration

Mechanics of the sterilisation process

Advantages/disadvantages of the process

Materials for which the process is suitable/unsuitable

Standard reference conditionsLectures 10-11 Validation and monitoring of sterilisation

Biological indicators

Sterility testing

Pharmacopoeial and regulatory requirementsLecture 12 Pyrogen and endotoxin testing

LAL tests

Practical classes (12h)

1. Bioburden determination2. Steam sterilisation3. Sterility testing tutorial

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Theme 4: Antimicrobial agents: Activity, efficacy testing andproduct preservation

Lecture 1 Measurement of antimicrobial activity

Factors influencing accuracy & reproducibilityLecture 2 Antimicrobial efficacy

Minimum inhibitory concentrations of antibiotics Disinfectant performance and use in relation tocontamination control in hospital and industrialsetting

Lecture 3 Antibiotic assays

Methods

Circumstances when undertaken

The influence of sample characteristics onassay selection

Lectures 4-7 Product preservation

Measurement of preservative efficacy

Contamination and spoilage of pharmaceutical

raw materials and manufactured medicines Factors influencing activity of preservatives

Preservatives available, their characteristicsand applications

Practical classes (6h)

1. Biocide and antibiotic activity

Teaching and learningstrategies

The material will be presented by formal lectures (approximately 38 hrs)and practical classes (22 hrs) and will be supported by guided study(approximately 140 hrs including assessment).

Learning support Texts (current editions)

Pharmaceutical Microbiology. , SP, Hodges, NA, and Gorman, SPBlackwell Science.Handbook of Microbiological Quality Control. Baird, R, Hodges, NA andDenyer, SP, Taylor & Francis.Pharmaceutics: the Science of Dosage Form Design. Aulton, M E.,Churchill Livingstone.Principles and Practice of Disinfection, Preservation and Sterilisation,Fraise A, Lambert P and Maillard J-Y, Blackwell Science.Guide to Microbiological Control in Pharmaceutical and MedicalDevices. Denyer, SP and Baird, R , Taylor and Francis.British and European PharmacopoeiasPharmaceutical biotechnology: fundamentals and applications. DJA

Crommelin R.D. Sindelar & B. Maibohm (eds), London : RoutledgeBiopharmaceuticals: biochemistry and biotechnology. Walsh, G, Wiley.Instant notes in Molecular Biology. Turner, P., McLennan, A., Bates, A& White, M, Taylor & Francis

Assessment tasks Two hour end of module written examination (60%) (LO1, 2), andcontinuous assessment of manipulative laboratory exercises (40%)(LO3). The threshold for each component is 35%.

Brief description ofmodule content and/oraims (maximum 80 words)

This module builds upon the information contained in BY241, andconcentrates on the features of microbiology which are of practicalinterest and concern in pharmacy, i.e. the means by which microbialgrowth can be restricted or prevented and the exploitation of microbesin medicine production. In addition it seeks to provide the student withan insight into the current and potential applications of the so-called

'new biology' to the pharmaceutical industry.Area examination board to Biology and Biomedical Sciences

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which module relates

Moduleteam/authors/coordinator

K.Jennert-Burston, L. Barnes, G. Hanlon, B. Jones & N. Hodges

Semester offered, whereappropriate

1 and 2

Site where delivered Moulsecoomb

Date of first approval 2008Date of last revision

Date of approval of thisversion

2008

Version number 1

Replacement for previousmodule

CH333

Field for which module isacceptable and status inthat field

Pharmacy, Compulsory

Course(s) for whichmodule is acceptable andstatus in that course

MPharm. Compulsory.

School home Pharmacy and Biomolecular Sciences

External examiner Keith Kitson