Pharmacotherapy: Understanding Biotechnology Products

Taipei Medical University via Coursera

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Provider

Coursera
Pricing

Paid Course
Languages

English
Certificate

Certificate Available
Effort

6 weeks, 3 hours a week
Sessions

Self-Paced
Level

Advanced
Subtitles

English

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Overview

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Welcome to "Pharmacotherapy: Understanding Biotechnology Products," a specialized course led by Dr. Charles Lee. This curriculum offers a comprehensive exploration of therapeutic protein products, spanning from laboratory bench research to clinical implementation. Students will begin by tracing the evolution of biotechnology, from ancient fermentation practices to modern breakthroughs like recombinant DNA (r-DNA) and hybridoma technology. The course delves into core technical principles, including vector technology, antisense oligonucleotides, and bioinformatics. Through case-based exercises, learners will analyze critical clinical challenges such as immunogenicity, the formation of Anti-Drug Antibodies (ADAs), and advanced formulation strategies like pegylation and targeted delivery. A significant focus is placed on establishing PK/PD correlations, where you will investigate the biochemical differences between biologics and small molecules to optimize individualized dosing regimens. Finally, the course surveys major therapeutic classes and the emerging market of biosimilars. By mastering these scientific principles, pharmacists will be empowered to serve as expert consultants to physicians and dedicated advocates for patient safety in the rapidly expanding biologics era.

Syllabus

Biotechnology History

This module introduces the historical perspectives and evolution of biotechnology from its earliest definitions to modern applications. Prof. Charles Lee will guide learners through the clinical distinctions between conventional drugs and biologics, highlighting the regulatory frameworks of the US FDA (CDER/CBER) and Taiwan's TFDA/CDE. The curriculum explores early biotechnological milestones like fermentation alongside breakthroughs like recombinant human insulin. By the end of this module, learners will understand the wide scope of biotechnology applications and grasp the unique clinical opportunities and challenges facing modern pharmacists.

Biotechnology Principles, Techniques and Tools

This module introduces the core principles, techniques, and tools driving modern biogenetic engineering. Prof. Charles Lee will explain the components and structures of nucleic acids, alongside the mechanisms of recombinant DNA (rDNA) technology and gene therapy vectors. The curriculum explores essential laboratory techniques like Polymerase Chain Reaction (PCR)—focusing on denaturation, annealing, and elongation—as well as hybridoma technology for monoclonal antibody (MAb) production and humanization. By the end of this module, learners will be able to describe the step-by-step procedures of genetic manipulation and understand how these modern tools create advanced therapeutic options.

Immunogenicity of Biotechnology Products

This module introduces the critical concept of immunogenicity regarding therapeutic proteins and biotechnology products. Prof. Charles Lee will outline the various types of immune responses and the precise structural and clinical factors that influence antibody formation. The curriculum explores the clinical effects of induced antibodies and details proactive strategies to predict and reduce immunogenicity. By the end of this module, learners will be able to systematically evaluate immunogenic responses and implement strategic structural changes to minimize adverse clinical reactions.

Formulation of Biotechnology Products

This module introduces the complex principles of formulating and manufacturing biotechnology products. Prof. Charles Lee will discuss the stringent microbiological quality control and aseptic processing conditions necessary for parenteral biologics. The curriculum explores the clinical roles of formulation additives, structural modifications like pegylation, and how distinct routes of administration impact efficacy and targeted delivery. By the end of this module, learners will understand the specific quality and processing considerations that shape biologic dosage forms and optimize their clinical bioavailability.

pharmacokinetic/pharmacodynamic (PK/PD) Correlations of Biotechnology Products

This module introduces the intricate pharmacokinetic and pharmacodynamic (PK/PD) correlations unique to therapeutic proteins. Prof. Charles Lee will contrast large biologics with small molecule drugs, detailing a classic two-compartment model defined by half-life, clearance, and a characteristically small volume of distribution. The curriculum explores macromolecule binding, hepatic or renal clearance pathways, and five core PK/PD modeling frameworks—including direct and indirect link models utilizing the Emax evaluation approach. By the end of this module, learners will be able to evaluate PK/PD correlations to successfully optimize patient dosing regimens and streamline candidate drug selection.

Biotechnology Products Review

This module introduces a comprehensive clinical review of currently marketed biotechnology products. Prof. Charles Lee will compare conventional drugs and biologics across their pharmacological, biochemical, and formulation dimensions, categorizing biologics into physiologic (endogenous) and non-physiologic (exogenous) peptides. The curriculum explores the clinical indications for major rDNA and monoclonal antibody (MAb) products, while addressing best practices for handling, storage, and administration. By the end of this module, learners will be thoroughly familiar with therapeutic classifications and equipped to safely manage biological products in clinical practice.