glycoproteins Proteins that contain sugar side chains added as a posttranslational process; presence of sugar side chains often affects activity and in vivo stability.

glycosylation Adding one or more carbohydrate molecules onto a protein (a glycoprotein) after it has been built by the ribosome; a post-translational modification.

GMPs Good manufacturing practices; according to 21 CFR Parts 210, 211, 600, 610, and (for devices) 820, current good manufacturing practices (cGMPs) influence the manner in which biopharmaceuticals and other drugs and medical devices are produced. Standard operating procedures must be followed, processes must be validated, equipment must be qualified, and properly trained staff must maintain a clean/sterile environment.

Gram's stain/Gram's method A method developed by Hans C.J. Gram for identifying bacteria. Bacteria are stained with gentian violet, then treated with Gram's solution (water, potassium iodide, and water) and counterstained. They are then treated with alcohol and washed with water. Gram-negative bacteria do not retain the purple dye (E. coli, for example); Gram-positive bacteria do retain the purple dye (Staphylococcus aureus, for example).

GRAS Generally recognized as safe; a special status afforded by FDA to ingredients and methods that have a proven, longstanding history of causing no harm to humans or animals.

growth hormone A protein produced in the pituitary gland to control cell growth.

Guidance for Industry The next regulatory level up from a Points to Consider (PTC) document (and below official Code of Federal Regulations law).

GXP All-inclusive term for GCPs, GLPs, and GMPs.

H

HACCP Hazard analysis and critical control points analysis; a method used to perform risk assessment and risk mitigation. Each unit operation is evaluated to define what critical parameters must be kept within specified ranges, and the process control strategy is designed to monitor and control within that range. Used in the food industry with much success. (See also FMEA)

half-life The time it takes for 50% of a drug or drug formulation given to a patient to be eliminated or destroyed by natural processes.

GLPs provide guidance on the best practices for laboratory activities, from research techniques to records and documentation.

harm Physical injury or damage to the health of people, or damage to property or the environment. [From ISO 14971; see also ICH Q9]

hazard The potential source of harm [From ICH Q9; see also ISO/IEC Guide 51].

HCIC Hydrophobic charge induction chromatography; a type of HIC that is based on pH rather than salt concentration, allowing for elution under relatively mild conditions and eliminating the requirement for an associated filtration step in early separations.

HDMS™(IMS-TOF MS) System High Definition Mass Spectrometry™ (HDMS) Waters MS Technology that couples high-efficiency ion mobility separations (IMS) with time-of-flight (TOF) mass analysis. HDMS provides an additional dimension of information for separations, providing additional details on glycopeptide, protein, and polymers such as PEG that are conjugated to proteins, including determining partial sequence information of proteins, and differentiating by size and shape, as well as mass.

HeLa Human cervical cancer cells; an established cell line that is commonly used in biotechnology.

hemocytometer A device for counting blood cells.