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Drug Discovery & Biopharmaceutical Development (BS979)

Introduction

Students will develop a detailed knowledge of the potential for drug discovery and exploitation by the pharmaceutical industry and a critical appreciation of some of the various techniques in use.
Students will acquire an integrated understanding of the breadth and depth of medicinal drug design and productions.
The module also extends the knowledge base relevant to the development and exploitation of biopharmaceutical products by the pharmaceutical industry. Students will integrating of the information presented with the core ethos of the programme by addressing issues concerned with the regulation of pre-clinical and clinical trials, through the Regulatory Procedures of development of biopharmaceuticals into a commercial reality.

Principle learning Outcomes

Students will:

  • Have a broad, integrated knowledge of drug discovery and biopharmaceuticals and respective industries.
  • Critically assess the use of novel drug design techniques and their risk to the pharmaceutical industry
  • Demonstrate knowledge of drug and biopharmaceutical development for the treatment of common and rare diseases
  • Critically assess the commercial advantages and disadvantages when selecting a new drug target

Content

The fundamental principles of drug discovery for medicinal gain.
The process of drug discovery using molecular biology and genetic engineering.
Recent advances in drug discovery, rational drug design, biological principles and detailed consideration of the research and development.
Examples with proven exploitation whilst also addressing the limitations (and dangers) of the drug technologies and their commercial potential.
Biopharmaceutical products: proteins, viruses, gene and cell therapy, vaccines.
Commercial exploitation: markets, diseases, companies.
Cell substrates: Mammalian/bacterial/fungal/insect. Cell bank manufacture and testing
Development of a biopharmaceutical: Stages in development from pre-clinical safety studies through Phase I – II – III – IV clinical studies.
Regulatory Agencies; procedure, policies and guidelines.
Chemistry, Manufacture and Control (CMC).
Good Manufacturing Practice and Quality Assurance:
Manufacture: Processes for extracting, purifying, formulating and filling. Process validation and qualification.
Products: Vaccines, Advanced Therapy Medicinal Products, Biosimilars.