Introduction to Biopharmaceutical Science will provide the student with a broad overview of the Biopharmaceutical sector.

1. Demonstrate knowledge of the various technologies and disciplines that contribute to Biotechnology and Biopharmaceutical drug target discovery

2. Identify and describe the different types of Biopharmaceutical products including proteins, antibodies, hormones, nucleic acids etc.

3. Explain the fundamental techniques of genetic engineering and provide examples of their use in the production of bioproducts.

4. Evaluate cell models for expression of exogenous gene products and explain the process of gene expression and regulation within these systems.

5. Compare routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal) and evaluate current and novel drug delivery systems designed for biopharmaceutical products.

This module details the diverse array of manufacturing processes & equipment employed in the pharmaceutical industry, in combination with the product packaging techniques. Additionally, it provides the student with a broad understanding of the various types of medical devices available and the modes and methods of manufacture.

1. To detail the mainstream systems and equipment used for generation of EP and USP grade water for Pharm/Biopharma production and manufacture.
2. To demonstrate a knowledge of the various information technology applications operating in the pharmaceutical industry.
3. To distinguish how non sterile Pharma/cosmetic products are manufactured, processed and the packaging options/requirements suited to each type of formulation.
4. To describe the methods to ensure the sterility of pharmaceutical preparation to the point of primary container closure selection and processing.
5. Contrast solid dosage form production techniques, from dry powder mixing to finished dosage formation and the packaging methods and requirements.
6. To have an appreciationof the medical device industry and the main classification of product types.

This course is designed to provide an introduction to a range of statistical tools of relevance to scientists. Specific topics include an overview of statistical distributions, significance testing, uncertainty determination, linear regression and experimental design. The application of statistics for quality control and practical experience in the application of statistical features in the widely used Minitab and Microsoft Excel is particularly emphasised.

The teaching methods used will be a combination of lectures, self-study, labs, tutorials, and any combination of discussion, case study, problem-solving exercises and computer-based learning.

1. Describe basic statistical terms which are of relevance to the area of analytical science.

2. Graphically display and numerically summarise data using appropriatetables, graphs and measures of centre, spread and position.

3. Explain and apply concepts of basic probability including, conditional probability, Bayes’ theorem, independent events and counting formulae;

4. Make interferences about population parameters using sample statistics using confidence interval estimates and tests of statisticalhypotheses

5. Describe the application of statistics tosampling, quality control, analytical method validation andexperimental design.

6. Use an appropriate method for analysingrelationships between variables in a dataset

This module covers the essential aspects of separation science for pharmaceutical samples. It addresses the issues of quality within measurements and examines the various sample types encountered within the pharmaceutical industry. It also addresses aspects of sample preparation and pretreatment.

1. Describe the purpose of the most common analytical tests carried out in the context of pharmaceutical manufacturing and quality control.

2. Relate key structural and physicochemical properties of pharmaceutical compounds to their analysis: eg appropriateanalytical techniques, sample preparation and analytical conditions

3. Identify suitable sample preparation techniques for a variety of pharmaceutical samples

4. Perform qualitative and quantitative laboratory analyses on Pharmaceutical APIsand Finished Products using a selection of compendial and non-compendialmethods and with due consideration of GLP/GMP

5. Interpret data from qualitative and quantitative chromatographic determinations in relation to a stated test hypothesis or quality specification

This module involves the synthesis of a range of Active Pharmaceutical Ingredients and associated regulatory aspects of the process.

1. Demonstrate competence in the application of a range of organic chemical synthetic techniques to the production of some common active pharmaceutical ingredients.

2. Determinequantities ofstarting materials as well as relevantglassware and equipment required for each synthesis.

3. Generate and follow Standard Operating Procedures (SOPs) in theuse of some standard laboratory equipment.

4. While working as a member of a group, evaluate the risks associated with each synthetic method and understand how to mitigate against these risks.

5. Recordand report onthe synthetic method, including any deviations or variations to the process.