Skip main navigation

Anti-Hemophilic Factors

Most of the recombinant factor VIII products currently on the market incorporate proteins or raw materials derived from either human or animal sources. Next-generation recombinant factor VIII for the treatment …

Biologics and Biosimilar Overview

Therapeutic classes of biologics and biosimilars are presented, along with a list of then new approval in 2014. In a strict sense, reverse transcriptase inhibitors and tyrosine kinase inhibitors are …

Product Introduction

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 …

Immunogenicity Overview

The clinical consequences of antibody formation vary with the type and quantity of antibody present, and it may effect drug PK, PD, efficacy, and safety. Preclinical immunogenicity is not predictive …

Formulation Factors

Biologic drugs are highly complex molecules produced by living cells/organisms through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based …

Chimerization and Humanization

Specific mouse mAbs can be routinely generated in large amounts with the use of hybridoma technology. However, mouse mAbs cannot be used for therapy in human due to their immunogenicity. …

The Immune System

The immune system is a host defense network comprising many biological structures and processes within an organism that protects against disease. There are two types of immunogenicity in therapeutic biologics …

Bioinformatics

Bioinformatics is an interdisciplinary science that develops capacities for storage, retrieval, organization and analysis of biological data. It arises because of the need to manage the explosion of publicly available …

Pegylation and Glycosylation

PEGylation and glycosylation are utilized to modify protein by forming protein-polymer conjugates with different assembled structure and enzyme activity. The coupling via click chemistry induce further self-assembly of conjugates into …

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 …

Immunities Overview

Different types of immunity are compared, natural vs artificial, innate vs acquired, active vs passive, with considerations of origin, acquisition time, onset and duration of immunity. Natural immunity occurs through …

Immunogenic Response

Biological agents are structurally immunogenic, and therefore usually elicit a minor, subclinical and transient response. Occasionally, however, these biologics induce complete cellular and humoral immune responses, with main clinical consequences …

Introduction to Biotechnology Techniques and Tools

Welcome to week 2. This week, we are going to talk about biotechnology principles, techniques and tools. The dawn of modern biotechnology started with two crucial technologies: genetic engineering and …

Peptide Technology

While peptides are naturally-occurring, there are synthetic peptides that can trigger pharmacological effect of proteins or organic compounds. Peptides are responsible for regulating a variety of cell functions, including metabolism, …

Cloning of Dolly the Sheep

Genetic cloning is the process of taking genetic information from one living subject and creating identical copies of it, including genes, cells or organisms. There are three different types of …