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Skip to 0 minutes and 14 seconds Dear fellow students, welcome to the biotechnology mini-series again. This is Dr. Lee. And today we are going to cover immunogenicity of biotechnology products. And the materials are taken from this two references. Learning objectives. To describe types of immune response and immunity. To described factors that influence antibody formation of therapeutic proteins. Describe the structure factor of immunogenicity. Summarize clinical effect of induced antibodies. To predict immunogenicity. And to summarize strategies to reduce immunogenicity. So what is the difference between immunity and immunogenicity. Very briefly, immunity is what we want. We need a good defense immune system or immune response on the other hand immunogenicity of biologics is usually undesirable. but immunogenicity is derived from immunity.

Skip to 1 minute and 51 seconds This slide shows the human immune systems. By the way, we ought to be very thankful to our human immune systems. The immune systems are everywhere and work very hard to protect us. In the lymphatic tissues, in the thymus, in the spleen, in the bone marrow And even in the appendix, and all together, they form a very strong defense system. There are two type of immune responses. The Innate immune response and the adapted immune response. Innate immune response is typically nonspecific. For example, the immediate first-line response, or the early induced in that immunity. And I will show you an example shortly after. On the other hand adapted immune response is specific. This example, this slide shows the innate inflammatory response.

Skip to 3 minutes and 9 seconds For example, your skin is injured by a rusty nail. And the bacteria got into the tissue. The lesion in the skin tissue would cause a chemical substance to be released which sent out an SOS signal to the blood vessel. And the phagocyte in the blood vessel would then migrate to the infected area. And gobble up the bacteria, so this is the innate inflammatory response. Adaptive immunity is acquired not born with, in contrast with in that immunity. They are derived by B lymphocyte or mediated by the B lymphocyte. or mediated by T lymphocytes.

Skip to 4 minutes and 8 seconds The B cells recognize their cognate antigen in its native form but on the other hand, the T cells recognize antigen in a processed form that is antigens expressing MHC molecules.

Immunity and Immunogenicity

Welcome to week 3. This week, we are going to look at the immunogenicity of biotechnology products. Immunogenicity is defined as the propensity of the therapeutic biologics to elicit immune responses in the form of Anti-Drug Antibodies (ADAs). Immune responses to therapeutic biologics may pose problems for both therapeutic efficacy and patient safety. Both patient-related and product-related factors may affect the immunogenicity of therapeutic biologics. These factors should be taken into consideration in the early stage of therapeutic biologics development.

Initially, immunity and immunogenicity are compared. Then, differences between innate and adaptive immunity are illustrated. Finally, factors that affect immunogenicity, clinical effects of induced antibodies, and strategies to reduce immunogenicity are outlined.

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This video is from the free online course:

Pharmacotherapy: Understanding Biotechnology Products

Taipei Medical University