PHA-30057 - Modern Biotherapeutics
Coordinator: Patricia Ragazzon Tel: +44 1782 7 34767
Lecture Time:
Level: Level 6
Credits: 15
Study Hours: 150
School Office:

Programme/Approved Electives for 2026/27

None

Available as a Free Standing Elective

No

Co-requisites

None

Prerequisites

none

Barred Combinations

None

Description for 2026/27

Over 40% of the pharmaceutical sector is devoted to a new area called biopharmaceutics. This sector encompasses peptides, proteins, hormones, polymers, stem cells, nucleic acid derived products and much more. Currently a substantial portion of the cosmetic industry is also using biologic products such as hyaluronic acid, collagen and chondroitin.
This module aims to build on existing knowledge and discuss in depth advances in the sector.

Aims
This module aims to build on existing knowledge on biologics taught in previous years of the programme, and discuss in depth for the advances in the sector.

Intended Learning Outcomes

Critically review the origin, structure, nature and importance of biological products in the pharmaceutical industry, including production and assessment.: 2
Compare suitable solutions to reduce bottlenecks, avoid product recall, and safeguard patient safety in the manufacture of biological products.: 1
Evaluate the mode of action of biological products and predict possible side effects.: 2
Demonstrate knowledge and understanding of all aspect of formulation and manufacturing of biologics considering quality assurance processes.: 1

Study hours

Laboratory 4
Tutorials 6
Interactive lectures 20
Lectures 20
The independent study hours (100) will cover exercises, problems, reading and material preparation. Guidelines and materials are provided in KLE.

School Rules

None

Description of Module Assessment

1: Report weighted 40%
Practical skills
A 1000 words laboratory or data-based report evaluating different techniques to monitor the stability and / or production, packaging, presentation and all general information of a biological product. You will use QA, QbD and RM principles to inform your conclusions.

2: Assignment weighted 60%
Case study
A 2000 words assignment critically evaluating a biopharmaceutical product from identification of target, manufacture / formulation / delivery system, mode of action and on each section to use the principles of QbD to identify risks and mitigation steps.