Stem Cell Biologic Process
From Source to Storage
A simple, patient-friendly explanation of how biologic materials move through sourcing, handling, quality review, preservation, and controlled storage.
Sourcing & processing
The record of a single lot, step by step.
Donated by consenting mothers at the time of delivery, cultivated under strict quality assurance, released only after independent verification. Each step carries its own control point, and all nine are recorded against the lot number printed on the unit you receive.
9
Controlled steps
3
Phases
Phase 01 · Sourcing
Steps 01–03 · consent, eligibility review, licensed collection
01
Consenting donors, rigorously screened
Tissue is donated by consenting mothers at the time of delivery. Donors are healthy women without disease, thoroughly screened for communicable disease. A full medical and social history is collected and reviewed by a Medical Director to confirm every donor meets eligibility requirements.
Control point
Medical Director reviews every donor file
02
Collection by licensed professionals
Tissues are collected only after full-term live births by C-section, and only by licensed clinical professionals working inside accredited facilities.
Control point
Accredited facilities only
03
48-hour processing window
There is a strict 48-hour window to process fresh tissue after collection. This preserves the biological integrity and potency of the source material.
Control point
Hard 48-hour limit from collection
Phase 02 · Processing
Steps 04–06 · decontamination, lot identification, cryopreservation
04
Cleaned and decontaminated
All tissues are cleaned and decontaminated during processing. We follow strict, documented protocols to ensure the tissue is free of pathogens before any downstream handling.
Control point
Documented decontamination protocol
05
Lot identification and traceability
Each tissue is uniquely identified by lot. Every lot is processed and documented in adherence with all applicable regulations, so any unit can be traced back to its source.
Control point
Unique lot identifier per unit
06
Slow-rate freezing at −80 °C
Product viability is preserved through a controlled slow-rate freezing process and storage at −80 °C, protecting cellular structures and bioactive components.
Control point
Controlled freeze curve, monitored storage
Phase 03 · Verification & release
Steps 07–09 · third-party testing, quarantine release, cold-chain delivery
07
Independent third-party sterility testing
Samples from each lot are sent to an outside CLIA-certified testing facility. Every lot is held in quarantine until testing is complete.
Control point
Outside CLIA-certified laboratory
08
Quarantine release
Once a lot passes the full testing phase and meets our internal release criteria, it moves out of quarantine and becomes eligible for clinical release.
Control point
Internal release criteria met
09
Overnight shipment on dry ice
Released product ships overnight to licensed clinics on dry ice to preserve viability. Individual product use is tracked internally by patient and lot.
Control point
Delivered to your clinic, tracked by lot
All nine steps are recorded against the lot number printed on the unit you receive.
Cold-chain integrity
Preserved at −80 °C. Verified before release. Shipped overnight on dry ice.
Every step, from slow-rate freezing through quarantine, third-party sterility testing, and final overnight shipment, is documented and tied to the lot delivered into your treatment.
Storage temperature
−80 °C, monitored
Release gate
Quarantine until testing clears
Transit
Overnight, dry ice, tracked
Handling standards
Four conditions the product travels under.
Products are handled under defined storage and transport conditions designed to maintain integrity throughout the distribution process.
Storage standards
Released product is held under controlled-temperature storage with documented monitoring. Storage conditions are defined per product format and maintained until distribution.
Recorded as
Temperature log per storage unit
Shipping conditions
Shipments are prepared under cold-chain conditions appropriate to the product format, packaged for overnight delivery to qualified clinics, and tracked from dispatch through receipt.
Recorded as
Tracking from dispatch to receipt
Chain of custody
Lot identification and custody records are maintained from release through clinic receipt, with documentation available to qualified providers on request.
Recorded as
Custody record per lot
Product integrity
Lot identification, packaging integrity checks, and temperature-controlled handling are intended to maintain product integrity from release through clinic receipt.
Recorded as
Packaging integrity check at release
Not an FDA-approved drug. Used by licensed physicians under the Practice of Medicine for cosmetic and regenerative support. Not intended to diagnose, treat, cure, mitigate, or prevent any disease.
