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 …
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 …
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 …
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 …
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 …
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 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 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 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 …
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 …
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 …
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 …
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 …
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, …
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 …