The module will teach students about key aspects of biotechnology as it relates to the development of medicines for human use. Coverage will include a survey of the medical uses of vaccines, proteins and peptides. Students will learn about recombinant technology, protein purification, characterisation and formulation. A key focus of the module will be to ensure students understand the different classes of proteins (e.g. blood factors, antibodies, alpha helical barrel proteins) that are used clinically.  Discussion will also cover regulatory issues, including biosimilars and biobetters. Future perspective will be provided by covering companion diagnostics and principles of cell based therapies.

 List of lectures:

  Introduction to pharmaceutical biotechnology
 
  Clinical use/classification and intro to protein therapeutics
 
  Introduction to monoclonal antibodies (PK properties/functions)
 
  Vaccines
 
  Monoclonal antibodies to treat cancer
 
  Protein purification-characterisation: overview
 
  Antibody-based medicines to treat inflammation
 
  Protein formulation/freeze drying
 
  Alpha-helical barrel proteins-cytokines (IFN-a2 to treat HCV); need for half-life extension
 
  Protein purification/characterisation-2: concentration / determination
 
  Other helical barrel proteins: multiple sclerosis (IFN-b); growth deficiency (HGH)
 
  Protein purification/characterisation-3: SDS PAGE/blotting
 
  Blood and anemia (EPO)
 
  Protein purification/characterisation-4: separation by charge, size, affinity, hydrophobicity
 
  Coagulation factors and clot busters (thrombolytic)-which are enzymes
 
  Protein purification/characterisation-5: Determination of aggregation and immunogenicity
 
  Wrinkle busters: Botox (a neurotoxin)
 
  Protein purification/characterization-6: Determination of protein activity/potency and -7: protein fingerprinting
 
  Insulin, GLP1 agonists (Exenatide once weekly) and other clinically used peptides; formulation to extend duration of action
 
  Formulations for subcutaneous administration: Herceptin SC
 
  Considering costs for intravitreal injection (ranibizumab, aflibercept, bevacizumab)