BIO07016 2013 BIOPHARMACEUTICALS 2

Outline the various technologies and disciplines involved in the production of Biopharmaceuticals.

Identify and evaluate the key factors that are involved in the design of an upstream bioprocessing system. 

Describe and analyse the various approaches to downstream purification including chromatographic techniques, filtration technology, centrifugation, electrophoresis & viral exclusion techniques.

Formulate and communicate judgements with regard to challenges in the formulation of biopharmaceuticals and explain the principal stages of sterile fill-finish operations.

Demonstrate knowledge of the key elements in a systematic approach to Biopharmaceutical Process Validation.

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

Recognise ethical and regulatory issues relating to the biopharmaceutical industry.

Assessment of the Biopharmaceuticals 2 module will include both continuous assessment and a terminal exam. Continuous assessment  will involve a range of assessment types including  case studies and  multiple choice quizzes.  A key focus of this module is to develop the student's team skills. To achieve this, students will be assigned a group project and be expected to participate constructively within a complex team environment. The team project will require the student's to work together to solve complex technical problems, plan for effective project implementation and manage the organisation of tasks, people and resources.

The range of topics covered will include some of the following:

Upstream processing:

• Fermentation Technology
• Key features of bioreactor design  
• Describe the main aspects of bioreactor control and operation
• Bioreactor modes of operation 

Downstream processing:

• Chromatographic techniques
• Filtration technology
• Centrifugation
• Electrophoresis 
• Viral exclusion techniques

Formulation-Fill Finish:

• Aspects of preformulation of relevance to Biopharmaceutical formulation 
• Dosage forms: Liquid, Frozen liquid, Solid Lyophilized (freeze-dried) etc
• Main types of excipients (stabilizers) used in biopharmaceutical formulation.
• Lyophilization Technology.
• Sterile fill-finish operations for biopharmaceuticals.

Validation:

• Overview of Validation Methodologies with specific application to Biopharmaceutical Manufacture.   
• Risk Identification, Risk Assessment and Risk Management for Biopharmaceutical Manufacture e.g. FMEA.
• Process Validation for Upstream and  Downstream Processing
• Validation Methodology for Viral Control of Biopharmaceuticals. 

Drug Delivery:

• Routes of Administration: Parenteral, Oral, Pulmonary, Nasal, Transdermal etc
• Controlled release
• Targeted delivery 
• Specialised delivery systems