Antibody: a protein produced by cells of the immune system, which specifically recognizes a target molecule known as an antigen. Antibodies are key components of the body's defense mechanisms.

Antigen: a molecule that binds to an antibody and is capable of stimulating specific antibodies in the body.

Bioconjugate vaccines: immunogenic (= inducing an immune response) complexes of polysaccharides and proteins.

Conjugate vaccines: vaccines created by attaching a sugar antigen to a carrier protein and thereby conferring the immunological attributes of the carrier on the attached antigen.

E.coli: one of the main species of bacteria living in the lower intestines of mammals and assists with waste processing, vitamin K production and food absorption. In the wrong environment, it can cause several intestinal and extra-intestinal infections such as urinary tract infections, meningitis, peritonitis, mastitis, septicemia and Gram-negative pneumonia.

Glycoprotein: a biomolecule composed of a protein and a carbohydrate.

Immunogenic glycoproteins: glycoproteins that induce an immune response.

In vivo: relating to a biochemical process or reaction taking place in a living cell or organism as opposed to in vitro, taking place in an artificial environment such as a test tube.

Monoclonal antibody: an antibody derived from a single clone of cells; all antibodies derived from such a group of cells have the same sequence of DNA.

Phase I: this study includes the initial introduction of an investigational new drug or IND into humans. Phase I studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness. During Phase I, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase II studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 – 80. Phase I studies also include studies of drug metabolism, structure-activity relationships and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.

Phase II: this study includes the controlled clinical activities conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase II studies are typically well controlled, closely monitored and conducted in a relatively small number of patents, usually involving no more than several hundred subjects.

Proof-of-principle: a study which demonstrates an effect which results in a biological change which is closely related to the proposed mechanism of action and known to be associated with disease activity in patients. Proof-of-principle can also be carried out in patients or healthy volunteers using appropriate challenge agents provided that a clear link can be established between the effect and the target disease.

Pre-clinical development: a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. The main goals of pre-clinical studies are to determine a drug's pharmacodynamics (PD), pharmacokinetics (PK), ADME and toxicity.

Protein glycosylation: the process or result of the addition of saccharides to proteins.