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, pre-clinical
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 robustness Ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact
on quality. [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].
prodrug A modified version or precursor of a parent compound designed to enhance delivery properties and be converted to the parent
compound in the body.
product specification A list of tests and acceptance criteria (limits) that are used to define the quality of a drug substance or drug product.
The specification is often listed on the Certificate of Analysis along with results for a specific batch or lot.
product variant A molecule that is related to the product but differs from it chemically, such as a degradation product, intermediate, or
different configuration of the protein of interest due to deamidation or other chemical reactions.
prokaryotes Simple organisms, such as bacteria, with no cell nuclei and only a few cell organelles.
protease An enzyme that cleaves the peptide bonds linking amino acids in protein molecules, classified according to the most prominent
functional molecular group (such as serine or cysteine) at the active site; also called proteinase.
In addition to chromatography, recovery and purification efforts most often include one or more filtration steps using filters
proteinase K A serine protease (used in molecular cloning and DNA sequencing, nucleic acid research, and protein and peptide structural
analysis) with broad specificity toward aliphatic, aromatic, and other hydrophobic amino acids, cleaving their peptide bonds.
protein truncation Shortening a polymeric chain of amino acids; the protein truncation test developed by Dutch researchers screens proteins to identify abnormally short molecules that suggest the location of genetic
protein variants Proteins with the same amino acid sequences but different folds or different carbohydrate residues. They must be separated
from the therapeutic proteins.
proteins Complex organic macromolecules whose structures are coded in an organism's DNA. Each is a chain of more than 40 amino acids
in peptide linkages that folds back upon itself in a particular way. Proteins are the principal constituent of all cell protoplasms
(the entire contents of a live cell). Each protein has a unique, genetically defined amino acid sequence that determines its
specific shape and function (as enzymes, structural elements, hormones, and immunoglobulins, involved in oxygen transport,
muscle contraction, or electron transport, for instance).
proteolysis Separation (cleavage) of peptide bonds in proteins by proteases (enzymes that recognize and cut specific peptide bonds) or
proteolytic Capable of lysing (denaturing, or breaking down) proteins.
proteomics Study of protein function and structure.
protocols Documentation (submitted to FDA or other agency in support of regulatory filings) that directs the work performed in an FDA-regulated
company. Protocols tell who directs which activities, who approves what, and who is allowed to sign off on materials and products,
even where to find specific files and documents — all tying together numerous SOPs.