Course: Pharmacotherapy: Understanding Biotechnology Products

The principle behind antisense technology is that an antisense nucleic acid sequence base pairs with its complementary sense RNA strand and prevents it from being translated into a protein. The …

Genetic engineering is the manipulation of an organism’s genes using biotechnology. Crop plants, farm animals, and soil bacteria are some of the more prominent examples of organisms that have been …

Hybridoma technology is a method for producing large amounts of identical antibodies, hence monoclonal antibodies, as opposed to the conventional polyclonal antibodies. Being foreign to human, the murine antibody is …

With its revolutionary yet inexpensive biochemical technology, PCR is considered to be one of the most indispensable techniques used in the medical and biochemical research laboratories. PCR is an in-vitro …

In molecular biology, a vector is a virus or a plasmid that carries a piece of foreign (treatment) DNA to a host cell, to accomplish insertion, deletion, replacement, exchange or …

Pegylation and glycosylation are biochemical processes used to improve the therapeutic function of a protein. Typically, the PEG moiety or the glycosylic moiety offers advantages for increasing the protein’s solubility, …

Biologics exhibit higher molecular weight, complexity in structure, and function that can be affected by changes in the manufacturing process. Initial emphasis on biologics development should be directed to the …

The selection of a sterilization strategy for a drug product that requires aseptic manufacturing is generally determined by the stability of the drug substance. For stable products, terminal sterilization, including …

For now, most biologics are administered via the intravenous or subcutaneous route, both requiring the injectable dosage form. The increasing use of biologics has stimulated innovations in novel injectable drug …

An excipient is pharmacologically inert by itself, but when used in combination with an active ingredient provides appreciable benefits. Biological molecules are inherently less stable than small molecules and formulation …

Excipients are an integral part of biological products, used in multiple ways, and have well defined functional roles. These roles include (a) enhancing solubility of the active, (b) enhancing process …

Proteins and peptides with demonstrated activity on the molecular and/or cellular level often fail to produce sufficient efficacy when applied in vivo, largely because of their unsatisfactory pharmacokinetic profiles. These …

Small molecule drugs are primarily cleared either through hepatic metabolism or renal excretion. In contrast, biologics are eliminated mainly via intracellular proteolytic degradation which occurs throughout the body, or receptor …

After SC administration, protein drugs can be transported to the systemic circulation directly via blood capillaries or indirectly via the lymphatics, both of which contribute to the absorption of protein …

Oral administration would be the most convenient and preferred method of drug administration, however, it is currently not possible for biologics. Instead, IV infusion and subcutaneous injection are commonly adopted …