Skip to content

PRECISION BIOLOGICS / GLOSSARY

Glossary

2

21 CFR Part 1271

A

AABB

AATB

↗Tissue products

Adipose-derived tissue

↗Clinic operations

Adverse event reporting

↗Tissue products

Allograft

↗Tissue products

Amniotic fluid

↗Tissue products

Amniotic membrane

B

Clinic operations

Bioburden

↗Tissue products

Biological scaffold

Biologics License Application (BLA)

↗Tissue products

Bone marrow aspirate concentrate (BMAC)

C

CBER

↗Cell biology

CD73, CD90 and CD105

↗Cell biology

Cell line

↗Cell biology

Cell viability

↗Clinic operations

Certificate of analysis (COA)

cGMP

↗Clinic operations

Chain of custody

↗Clinic operations

Chain of identity

↗Clinic operations

Cold chain

↗Cell biology

Collagen

↗Cell biology

Colony-forming unit (CFU)

↗Cell biology

Conditioned medium

↗Tissue products

Cord blood

↗Clinic operations

Cryopreservation

↗Tissue products

Cryopreserved allograft

↗Cell biology

Cytokine

D

Tissue products

Decellularized tissue

Donor eligibility determination

↗Clinic operations

Dry ice shipping

↗Clinic operations

Dry-ice validated shipper

E

Extracellular vesicles

ELISA

↗Clinic operations

Endotoxin testing

Enforcement discretion

Establishment registration

↗Extracellular vesicles

EV particle concentration

↗Extracellular vesicles

EV source cell

↗Extracellular vesicles

Exosome

↗Cell biology

Extracellular matrix (ECM)

↗Extracellular vesicles

Extracellular vesicle (EV)

F

FDA untitled letter

FDA warning letter

FTC health claims substantiation

G

Google Ads health policy for cell therapies

↗Cell biology

Growth factor

↗Quality & testing

Growth factor panel

H

HCT/P

Homologous use

↗Cell biology

Hyaluronic acid

I

Informed consent

Intended use

↗Clinic operations

Inventory rotation

Investigational New Drug (IND)

↗Cell biology

ISCT minimal criteria

L

Clinic operations

Lot traceability

↗Extracellular vesicles

Lyophilization

↗Tissue products

Lyophilized allograft

M

Manufacturing arrangement

↗Clinic operations

Medical director

↗Cell biology

Mesenchymal stromal cell (MSC)

↗Extracellular vesicles

Microvesicle

Minimal manipulation

↗Extracellular vesicles

MISEV guidelines

N

Extracellular vesicles

Nanoparticle tracking analysis (NTA)

↗Clinic operations

NPI number

↗Clinic operations

NPI verification

O

Tissue products

Off-the-shelf allograft

↗Tissue products

Orthobiologics

P

Paracrine signaling

↗Extracellular vesicles

Particle count

↗Tissue products

Perinatal allograft

↗Cell biology

Perinatal tissue

↗Tissue products

Placental tissue

↗Tissue products

Platelet-rich plasma (PRP)

↗Clinic operations

Product insert

↗Cell biology

Progenitor cell

↗Cell biology

Proteoglycan

Q

Clinic operations

Quarantine and release

↗Quality & testing

Quarantine release

S

Secretome

Section 351 biological product

Section 361 HCT/P

↗Extracellular vesicles

Size-exclusion chromatography

↗Clinic operations

Slow-rate freezing

↗Extracellular vesicles

SP-IRIS

State experimental treatment laws

↗Cell biology

Stem cell

↗Clinic operations

Sterility testing

↗Clinic operations

Supplier audit

Systemic effect

T

Extracellular vesicles

Tangential flow filtration

↗Clinic operations

Temperature excursion

↗Extracellular vesicles

Tetraspanin markers (CD9, CD63, CD81)

↗Tissue products

Tissue bank

↗Cell biology

Tri-lineage differentiation

U

Extracellular vesicles

Ultracentrifugation for EV isolation

↗Cell biology

Umbilical cord

↗Tissue products

Umbilical cord matrix

Unapproved new drug

Unlicensed biological product

V

Clinic operations

Vendor qualification

W

Tissue products

Wharton's jelly