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Product Introduction

Dear fellow students, this lecture is the very last part of the biotechnology mini-series. I’m sure you are so relieved that it is over finally. So without further ado, part 6, biotechnology product review. And the materials are taken from these two reference books. Learning objectives. To be able to describe the physiologic classification of biotechnology products. To familiarize with yourself, with the marketed recombinant DNA products and their indications. And also to familiarize with the marketed monoclonal antibody product and their indications. Learn to exercise cautions with handling storage, dispensing, and administration of biotechnology products. And to overview their therapeutic classes of the biosimilars. First, let’s talk about the differences between biologics and small molecule drugs.
Pharmacologically, biologics have higher target specificity, And because of that, they have greater therapeutic potency. They usually have fewer side effects but the side effects could be very serious. Short duration of action. Biochemically, large molecular weight for the biologics. Therefore, low membrane permeability and negligible oral absorption. Low renal filtration. And biologics are subject to nonspecific metabolism. They are also subjective biofeedback mechanism or the auto-regulation, particularly for the endogenous proteins. In terms of formulation, they are subject to the effect of pH, buffer, osmoticity, molecular aggregation, precipitation, which is concentration dependent. And the interfacial adsorption. And in general speaking, they have shorter half-lives. And the small molecules, the formulation factors are not this complex. Biotechnology products,
biotechnology products are divided into two categories: physiologic peptide, and non-physiologic peptide. Physiologic peptides are existent under normal physiological conditions, and they are divided into two subclasses. They exist in pharmacologic concentration. For example, the clotting factors, insulin, human growth hormone, and erythropoietin. And the dose that exists in non-pharmacologic concentration. For example, the interferons, the cytokines, TPA(tissue plasminogen activator), urokinase. They exist in such a small quantity under normal physiologic conditions. They only search upon the stress and challenge from the external conditions. Non-physiologic peptides, of course, they do not exist under normal physiologic conditions. For example, the vaccines and the antithromobody.

Welcome to the final week. This week, we are going to look at biotechnology products review. Biologics and drugs differ with respect to pharmacology, biochemistry and formulation. Biologics are divided as physiological peptides of endogenous origin, and non-physiological peptides of exogenous origin. Physiologic peptides are further divided into those existing in pharmacological concentration and those existing in non-pharmacological concentration

First, the learning objectives are listed. Second, drugs and biologics are compared with respect to pharmacological, biochemical and formulation characteristics. Biologics are divided in two categories, physiologic peptide(endogenous) and non-physiologic peptide (exogenous) Physiologic peptides are further divided into those existing in pharmacological concentration (clotting factors, insulin) and those existing in non-pharmacological concentration (interferon, cytokines)

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Pharmacotherapy: Understanding Biotechnology Products

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