Acronyms Flashcards
(23 cards)
1
Q
Amino Acid
A
- smallest molecular building block of a protein
2
Q
ATMPs
A
- Advanced Therapy Medicinal Products
- medicines for human use that are based on genes, tissues, or cells
3
Q
Biologic
A
- Biopharmaceutical products
- wide range of pharmaceutical with specific properties
- composed of sugars, proteins, nucleic acids, or living entities
- isolated form natural sources/produced by biotech methods
- heat sensitive, susceptible to microbial contamination
- complex mixtures
- complex production process
4
Q
Biomanufacturing
A
production of biologics
5
Q
BSC
A
- Biosafety cabinet
- biocontainment equipment used in biological labs to provide personal, environment, and product protection
6
Q
CE
A
- calculation error
- GDP: data calculated incorrectly
7
Q
CGT
A
- Cell and Gene Therapy
- CELL THERAPY: transfer of cells with the relevant function into the patient
- GENE THERAPY: involves transfer of genetic material (in carrier/vector) and the uptake of the gene into the appropriate cells of the body
8
Q
CIP
A
- clean in place
9
Q
CLR
A
- rewritten for clarity
- GDP: rewritten for clarification
10
Q
CQA
A
- critical quality attributes
- physical, chemical, biological, or microbiological property that should within an appropriate limit, range, or distribution to ensure desired product quality
11
Q
Da
A
- Dalton
- measurement unit for molecular weight
- size of a molecule
12
Q
DCS
A
- distributed control system
- system of sensors, controller, and associated computers that are distributed throughout a plant
13
Q
DE
A
- date error
- GDP: incorrect date recorded
14
Q
DNA
A
- deoxyribonucleic acid
- biological entity that contains the genetic code for proteins in living organisms
15
Q
DSP
A
- downstream processing
- recovery and purification of DS from natural sources (such as animal/bacterial cells)
16
Q
DP
A
- drug product or biological product
- finished dosage form (tablet, capsule, solution) that contains an active drug ingredient
17
Q
DS
A
- drug substance
- active ingredient that is intended to furnish pharmacological/direct effect in diagnosis, cure, mitigation, treatment, or prevention of disease
- affect structure/function of human body
18
Q
E. coli
A
- Escherichia coli
- microorganism used for biomanufacturing less complex biologics
19
Q
ELISA
A
- enzyme-linked immunosorbent assay
- immunological assay commonly used to measure antibodies, antigens, proteins, and glycoproteins
20
Q
EM
A
- environmental monitoring
- process that determines the quality of a controlled environment via microbial data collection
21
Q
Fc
A
- fragment crystallizable region
- tail region on a mAB that interacts with cell surface receptors and proteins of the complements system
- allows antibodies to activate the immune system
22
Q
FDA
A
- food and drug administration
- US regulatory agency
23
Q
FIT
A
- filer integrity testing
- equipment/test method used for testing whether filters are still intact/working
