Specimen traceability
Specimens are received directly after donor collection through medical institution collaboration and processed as quickly as possible before quality decline occurs.
Quality must be explainable before function is claimed.
Cell Reborn LLC organizes direct specimen receipt, infection risk evaluation, culture conditions, storage, and traceability for cell processing operations.
Quality Policy
Quality and safety evaluation from early R&D.
Culture supernatant and conditioned medium cannot be judged by appearance alone. Cell Reborn treats direct specimen receipt, dPCR/qPCR-based infection risk evaluation, hypoxic non-CO2 culture, distributed master stock storage, and working stock storage temperature and duration control as one quality design.
Safety in this page refers to R&D and process-evaluation considerations. It does not guarantee product safety, clinical efficacy, or regulatory approval.
Infection risk exclusion-oriented evaluation
dPCR and qPCR are incorporated to support decisions aimed at excluding detectable infection risks from the process.
Master stock management
Post-culture master stocks are distributed by default and stored in GMP-operated cell storage facilities under liquid nitrogen vapor phase conditions.
Working stock management
Because cells can deteriorate rapidly in -80 C deep-freezer storage, strict local rules are set for storage temperature and storage duration.
Control Points
Main control items
| Specimens and source material | Direct receipt immediately after donor collection through medical institution collaboration. Accepted specimens include subcutaneous adipose tissue, umbilical cord, fetal membranes (amnion, chorion, decidua), deciduous teeth (impacted), permanent teeth, and peripheral blood. Commercial reagent-like cells are not purchased and used as source material. |
|---|---|
| Specimens not used | Bone marrow and menstrual blood are not used under Cell Reborn's risk policy because of concern over strong cancer-cell proliferation-promoting potential and hygiene considerations. Umbilical cord blood is not used because it is a specimen for established standard treatment in public healthcare. |
| Culture process | T-flask-free rotary culture, hypoxic culture without CO2, medium composition, culture time, temperature, collection, filtration, and concentration |
| Infection risk evaluation | dPCR, qPCR, microbiological testing, mycoplasma, cross-contamination, and foreign matter risk evaluation |
| Quality evaluation | Appearance, protein amount, secretome, cytotoxicity, unwanted growth promotion, residuals, and use-specific risk review |
| Master stock storage | Distributed storage by default in GMP-operated cell storage facilities under liquid nitrogen vapor phase conditions |
| Working stock storage | Because cells can deteriorate rapidly in -80 C deep-freezer storage, strict local rules are set for storage temperature and storage duration |
Specimen Handling
Processing starts immediately after direct receipt.
Specimens are received directly after donor collection through medical institution collaboration, processed quickly before quality decline occurs, and introduced into culture. Accepted specimens include subcutaneous adipose tissue, umbilical cord, fetal membranes (amnion, chorion, decidua), deciduous teeth (impacted), permanent teeth, and peripheral blood. The process is not based on purchasing commercially sold reagent-like cells as raw material.
Direct receipt
The workflow prioritizes minimizing time from collection to receipt and process start.
Specimen selection policy
Bone marrow and menstrual blood are not used because of cancer-cell proliferation-promoting and hygiene risk concerns, and umbilical cord blood is not used because it is reserved for established standard treatment.
Hypoxic non-CO2 culture
Culture conditions are designed around hypoxic culture without CO2 use.
Distributed storage
Master stocks are managed with distributed storage as the default stance.