PHARMACEUTICAL BIOTECHNOLOGY II

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Learning Outcomes

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.