Category 5

MSC Collection, Culture, Processing, and Quality Testing

10 topics planned. Each topic is published as a Professional and Patient edition only after explicit author approval.

5.1Tissue procurement
In review
1. · Donor eligibility
2. · Consent
3. · Aseptic collection
4. · Collection materials
5. · Transport temperature
6. · Time to processing
5.2Initial processing
In review
1. · Tissue washing
2. · Dissection
3. · Digestion
4. · Filtration
5. · Centrifugation
6. · Initial cell recovery
7. · Cell counting
5.3Culture systems
In review
1. · Two-dimensional culture
2. · Three-dimensional culture
3. · Cell factories
4. · Bioreactors
5. · Microcarriers
6. · Closed-system processing
5.4Culture media
In review
1. · Fetal bovine serum
2. · Human platelet lysate
3. · Serum-free media
4. · Xeno-free media
5. · Chemically defined media
6. · Antibiotic use
7. · Growth-factor supplementation
5.5Cell expansion
In review
1. · Passage number
2. · Population doublings
3. · Seeding density
4. · Confluence
5. · Harvest methods
6. · Culture duration
7. · Scale-up
5.6Cryopreservation
In review
1. · Cryoprotectants
2. · Controlled-rate freezing
3. · Storage temperature
4. · Thawing
5. · Washing
6. · Post-thaw recovery
7. · Post-thaw functional changes
5.7Identity testing
In review
1. · Surface markers
2. · Morphology
3. · Differentiation
4. · Gene-expression profiles
5. · Functional assays
6. · Tissue-source confirmation
5.8Safety testing
In review
1. · Sterility
2. · Mycoplasma
3. · Endotoxin
4. · Adventitious viruses
5. · Donor-transmitted infections
6. · Tumorigenicity
7. · Genetic stability
5.9Product-quality attributes
In review
1. · Identity
2. · Purity
3. · Viability
4. · Potency
5. · Dose
6. · Consistency
7. · Stability
5.10Comparability
In review
1. · Manufacturing changes
2. · New culture media
3. · New equipment
4. · Facility transfer
5. · Scale-up
6. · Revised cryopreservation
7. · New analytical assays