Category 12

Manufacturing and Laboratory Standards

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

12.1Good Manufacturing Practice
In preparation
1. · Facility requirements
2. · Personnel training
3. · Controlled environments
4. · Documentation
5. · Deviation management
6. · Corrective and preventive action
12.2Cleanroom operations
In preparation
1. · Air classification
2. · Environmental monitoring
3. · Gowning
4. · Aseptic technique
5. · Cleaning
6. · Contamination control
12.3Starting materials
In preparation
1. · Donor tissue
2. · Culture media
3. · Supplements
4. · Enzymes
5. · Disposable systems
6. · Reagent qualification
12.4Cell banks
In preparation
1. · Master cell bank
2. · Working cell bank
3. · Donor traceability
4. · Qualification
5. · Storage
6. · Inventory controls
12.5In-process controls
In preparation
1. · Cell density
2. · Morphology
3. · Growth kinetics
4. · Culture conditions
5. · Contamination monitoring
6. · Harvest timing
12.6Release testing
In preparation
1. · Identity
2. · Purity
3. · Viability
4. · Potency
5. · Sterility
6. · Endotoxin
7. · Mycoplasma
8. · Dose verification
12.7EV manufacturing
In preparation
1. · Source-cell qualification
2. · Conditioned-media collection
3. · EV separation
4. · Concentration
5. · Purification
6. · Contaminant removal
7. · Particle characterization
8. · Potency
12.8Stability
In preparation
1. · Real-time stability
2. · Accelerated stability
3. · Shipping stability
4. · In-use stability
5. · Freeze–thaw stability
6. · Container closure
12.9Chain of identity and custody
In preparation
1. · Donor identification
2. · Sample labeling
3. · Batch records
4. · Product tracking
5. · Shipping documentation
6. · Administration records
12.10Manufacturing failures
In preparation
1. · Batch contamination
2. · Failed potency
3. · Low viability
4. · Product mix-ups
5. · Temperature excursions
6. · Deviations
7. · Recalls