This module examines various upstream processing aspects of a typical biopharmaceutical production process. It includes the various design factors that need to be considered for bioprocess design. The primary focus will be on recombinant mammalian cell culture lines with some aspects of microbial lines also included.

1. Identify and evaluate the main factors that are involved in the design of an upstream bioprocessing system including which cell line to choose for a particular processing application and the cellline storage conditions cell banking and cell culture scaleup.

2. Outline and evaluate the process kinetics relating to cell growth and productivity for a bioreactor process and the overall impact upon mass transfer balances in a bioreactor for air/oxygen and carbon-dioxide.

3. Identify and interpret the basic mass and energy transfer details for oxygen and carbon dioxide within a bioreactor process.

4. Evaluate and discuss the various designs of bioreactors available and their key features including relative advantages and disadvantages. Also describe the different options for media feeding systems.

5. Describe the main aspects of bioreactor control and operation including the various instrumentation types involved.

This module is taken by Masters students in Pharmaceutical or Biopharmaceutical Science or Engineering. It aims to provide students with a detailed knowledge and understanding of biopharmaceutical legislation in EU and US. It explains the legislation applicable and guidelines available to biopharmaceutical manufacturers.

1. Demonstrate they have detailed knowledge and understanding of the global regulatory framework for biotechnology derived products

2. Source and interpret EUDRALEX Volume 2 – \”Pharmaceutical Legislation : Notice to Applicants for Medicinal Products\”.

3. Intergrateknowledge and understanding of the drug development/clinical trial process with the drug approval process for EU and USA

4. Source and interpret procedures and directives currently regulating pharmaceutical production and sales within the EU including product registration, advertising and packaging, good manufacturing, laboratory and clinical practice and pharmocovigilance.
5. Evaluate the nature and production of biotechnology derived product and how these have a regulatory impact forquality, safety, and efficacy.

6. Formulate and communicate judgements with regard to regulatory issues for biopharmaceutical products.

This module will provide an overview of the regulatory, technical and management issues associated with the scale-up and technology transfer of industrial bioprocesses. The focus will be on giving a clear understanding of the technical and regulatory requirements and approaches necessary to obtain regulatory approval for product scale-up and transfer. It will provide guidance on how to implement efficient and effective projects and will also address such areas as process validation and the typical costs associated with these projects.

1. Discuss and evaluate the important process, engineering and regulatory aspects of technology transfer.
2. Formulate and communicate effective planning of a technology transfer process.

3. Provide some practical examples of technology transfer aspects and features.

This module covers much of the practical skills associated with cell culture and upstream processing in biopharmaceutical operations. The relevant learning is acquired through the completion of laboratory-based and pilot-plant based practical sessions that are designed to impart the required knowledge and skills required for upstream processing operations.

1. Demonstrate a range of practical skills associated with upstream processing in the biopharmaceutical industry.

2. Interpret and evaluate the data and results obtained from various upstream processing practicals.

3. Demonstrate the skills required for upstream bioprocessing operations.

4. Demonstrate effective communication skills.

This module examines various downstream processing aspects of a typical biopharmaceutical production process. It includes the various design factors that need to be considered for the design of an effective and efficient protein capture and purification process.

1. Design an effective and efficient downstream process for a protein capture and purification application.

2. Outline and evaluate the various approaches to primary capture of the target material focusing primarily on affinity chromatography.
3. Describe the theory and practice of chromatography for purification applications including the various chromatographic types available and their relative advantages and disadvantages.

4. Interpret and explain other downstream processing technologies such as microfiltration, ultrafiltration, diafiltration, centrifugation, electrophoresis and various viral exclusion techniques.

5. Outline and evaluate the main quality control and analytical techniques required for downstream processing.

The purpose of this module is to complete a research proposal which may subsequently form part of the MSc thesis. Students will have the opportunity to formulate a research topic, develop a research schedule and select appropriate methodologies for a research project. The learner will study different research methods, ethical considerations, learn how to critically analyse scientific documents, disseminate research in terms of reports, and communicate effectively.

1. Produce a research proposal document.

2. Undertake a focused literature search and generate a literature review on a research topic.

3. Select and apply an appropriate research methodology while adhering to ethical considerations.

4. Communicate effectively their research outcomes.

This module covers the practical knowledge and skills required for downstream processing in biopharmaceutical operations. The relevant learning is acquired through the completion of lab-based and pilot-plant based practical sessions that are designed to impart the relevant knowledge and skills required for downstream processing operations.

1. Demonstrate a range of practical skills associated with downstream processing operations

2. Interpret and evaluate the data and results obtained from various downstream processing practical sessions.

3. Demonstrate the skills required for upstream bioprocessing operations.

4. Demonstrate effective communication skills.

This module deals with advanced methods of biopharmaceutical formulation for stable drug delivery other than oral dosage forms which are not typically used for biopharmaceuticals.

1. Describe the key principles of preformulation.
2. Discuss the delivery methods for modern therapeutic proteins such as antibodies, growth factors etc.
3. Outline various non-invasive methods for drug delivery such as nasal, pulmonary, transdermal etc.
4. Describe polymer-based and lipid-based systems of drug delivery.
5. Describe the operating principles of lyophilisation.