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.

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.

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.

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.

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.

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.