pre-license inspection An FDA facility inspection performed in response to a bio-pharmaceutical company's filing of a BLA to confirm claims made
in the license application and assess the readiness and cGMP compliance of the manufacturing plant.
precipitation Process causing a solid to settle out of solution (as in centrifugation) by the action of gravity or by a chemical reaction;
a reaction between a soluble antibody and a soluble antigen, resulting in the formation of a substance (known as a precipitate)
that separates, in solid particles, from a liquid.
preformulation An exploratory activity that begins early in biopharmaceutical development, involving studies designed to determine the compatibility
of initial excipients with the active substance for a biopharmaceutical; physicochemical and bioanalytical investigation in
support of promising experimental formulations.
preparative chromatography Chromatography methods used in manufacturing rather than analytical applications, larger in scale and intended to purify a
product; also called process chromatography. Chromatographic methods were first used in analytical laboratories, and only
later in the 20th century were they adapted to industrial separations use. (Contrast with small-scale analytical chromatography.)
preservative A chemical additive that prevents spoilage by killing or inactivating microorganisms; also stabilizes molecules such as when
using antioxidants or sulfhydyls to stabilize proteins. (Contrast with bacteriostatic agent, which prevents microbes from
multiplying but does not kill them).
primary recovery The early steps in separation and purification of a biopharmaceutical, in which a complex biological solution containing the
protein of interest is concentrated and clarified, usually by means of filtration, centrifugation, or extraction (precipitation);
and the protein of interest is isolated from residual debris, cells, and other macromolecular materials.
Laboratories rely on the high purity and recovery achieved with preparative chromatography columns.
priori Believed to be the smallest, simplest infectious particle consisting of a hydrophobic protein (no nucleic acid, DNA, or RNA),
suggested as a possible model for the causal agent of scrapie and related diseases, called TSEs. (Term originally derived
from proteinaceous infectious particle.)
Proline; an imino acid often grouped with the 20 naturally occurring amino acids.
process analytical technology (PAT) A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of
critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final
product quality. [From ICH Q8]
process control 1. The means by which a process is monitored and operated, and is designed to maintain critical parameters within set ranges
determined to be safe. 2. A consistent process that follows predictable statistical trends and is monitored using control
charts is said to be in a state of "statistical control."
process development The step in the life cycle of a product that starts with information from research, and delivers a scalable process to manufacturing
plants that can be validated, operated under cGMP controls, and be commercially viable. During process development, preclinical
and clinical trials supplies of the product are manufactured.
process knowledge A compilation of all facts about a manufacturing process from development through full-scale manufacture.
process-related impurities Impurities that are derived from the manufacturing process. They may be derived from cell substrates (e.g., host cell proteins,
host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing (e.g., processing
reagents of column leachables). [From ICH Q6B]
process robustness Ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact
on quality. [From ICH Q8]
process understanding Comprehension of process knowledge such that all critical sources of variability are identified and explained; variability
is managed by the process; and product quality attributes can be accurately and reliably predicted over the design space established
for the materials and process. Through process understanding, process performance and product attributes can be explained
logically and scientifically as a function of process parameters, inputs, and input material attributes.
product lifecycle All phases in the life of the product, from the initial development through marketing until the product's discontinuation.
[From ICH Q9]