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  • Faculty of Pharmacy
  • Course Structure Diagram with Credits
  • Pharmaceutical Biotechnology II
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  • Will be able to explain Recombinant Protein Production and Purification Stages.
  • Classifies upstream processes.
  • Classifies large-scale fermentation processes.
  • Compares fermentor variants.
  • Discusses downstream processes.
  • Explains purification of recombinant therapeutic proteins.
  • Will Be Able to Explain the Final Product Formulation of Recombinant Therapeutic Protein.
  • Discusses pre-formulation data and excipient selection for formulation creation.
  • Discusses pharmaceutical drug forms comparatively.
  • Discusses formulation development for controlled release and targeting.
  • Lists validation studies.
  • Discusses final product stability studies and methods used.
  • Explains final product filling methods.
  • Discuss appropriate labeling and packaging methods.
  • Will Be Able to Explain Cytokines and Give Examples of Their Formulations.
  • Explains the biotechnological production of cytokines and their areas of use in treatment.
  • Explains the biotechnological production of interferons and their areas of use in treatment.
  • Explains the biotechnological production of interleukins and their areas of use in treatment.
  • Explains the biotechnological production of tumor necrosis factor and its areas of use in treatment.
  • Will Be Able to List Recombinant Hormones and Give Examples of Their Formulations.
  • Identify and classify growth factors.
  • Describes the formulation of human growth hormone.
  • Lists the production techniques of insulin.
  • Enumerates recombinant insulin production steps.
  • Identifies currently approved hormones.
  • Will Be Able to Count Recombinant Blood Products and Enzymes.
  • Classifies recombinant blood clotting factors approved for the management of coagulation disorders.
  • Lists therapeutic enzymes.
  • Will Be Able to Explain Antibodies, Vaccines and Adjuvants.
  • Discusses the importance of antibodies in the immune system.
  • Classifies the preparations used for immunization.
  • Discusses the humoral and cellular response.
  • Discusses the production techniques of polyclonal and monoclonal antibodies.
  • Explains the production techniques of monoclonal antibodies from plants and transgenic animals.
  • Gives examples of antibodies used in treatment.
  • Defines immunotherapy.
  • Explains antibody fragments and their areas of use.
  • Lists traditional vaccine preparations.
  • Classifies vaccines.
  • Explains modern vaccine techniques.
  • Discusses vaccine formulation development.
  • Lists vaccine adjuvants.
  • Will be Able to Explain the Use of Stem Cells in Treatment.
  • Defines somatic cells.
  • Defines stem cells and their types.
  • Explains stem cell production.
  • Defines stem cell treatment.
  • Will Be Able to Give Examples of Advanced Therapy Medical Products.
  • It exemplifies Advanced Therapy Medicinal Products (ATMU).
  • It defines personalised drug therapy.
  • Will Be Able to Discuss Biosimilars and Their Formulations.
  • Defines biosimilars according to FDA, EMA and TMMDA.
  • Defines the reference medical product.
  • Explains comparability in biosimilar products.
  • Summarizes the production of biosimilar products.
  • Will be able to list the characterization studies performed on biosimilars.
  • Lists analytical characterization studies performed on biosimilar and reference products.
  • Explains the determination of release and shelf-life limits.
  • Describes in vitro and in vivo pharmacodynamic studies.

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