How Do We Do It?
Donors are healthy women who are thoroughly screened for any communicable diseases. A medical and social history is collected and reviewed by Signature Biologics’ Medical Director to ensure that the mother meets all the eligibility requirements.
Tissues are collected after full term live births by c-section and conducted only by licensed professionals.
There is a 48 hour window to process the fresh tissue after collection.
All tissues are cleaned and decontaminated during processing. We follow strict protocols to make sure our tissue is free of pathogens.
Each tissue is uniquely identified by lot. Each lot is processed using our proprietary “Signature Process” and is adherent to all applicable regulations.
Preservation of product viability is ensured by a slow rate freezing process and storage at -65°C.
To ensure sterility, samples from each lot are sent off to a third party testing facility. Each lot undergoes quarantine until the testing has been completed.
When testing is complete, if the lot passes the rigorous testing phase and meets our internal release criteria, it moves from the quarantine stage and is eligible for sale.
Sales are completed and shipped overnight to doctors and hospitals on dry ice to ensure preservation of the product. Individual product use is tracked internally by patient.