Biotechnology is a highly competitive and regulated industry. Understanding the product life-cycle is crucial in ensuring efficient development of high quality and safe products that comply with regulatory standards and achieve market success. This course provides a complete overview of the biotechnology product life cycle, from initial concept, research and development and testing through to market launch and post-launch surveillance.

This course will run in semester 1

None

1. Group presentation of product roadmap for a biotechnology product (10 minutes, 25%) - (ILO 1 & 2)

2. Report individually on a biotech product with quality management plan (1500 words, 75%) - (ILO3) 

It is the default expectation that all courses will offer opportunities for reassessment or deferred assessment. Where it is not possible to offer this in some assessment components, the grade achieved at the first attempt will be counted towards the final course grade, and any exceptions for this course are described below.

[No exceptions]

This course aims to help students:

■ Build an understanding of the complete life-cycle of a product in the Biotechnology industry;

■ Explore the regulatory frameworks governing biotechnology products;

■ Overview of the principles of quality assurance, Good Manufacturing Processes (GMP) and risk assessment;

■ Develop management and communication skills relevant to a wide range of roles in the biotechnology industry and beyond.

By the end of this course students will be able to:

1. Critically evaluate the key stages of the product life cycle and justify the importance of efficient management;

2. Design a product life cycle roadmap for a biotechnology product;

3. Formulate risk assessment strategies to address potential challenges throughout the product life cycle.