Our Product Sourcing Process | New Life Regenerative Medicine

Process

Product Sourcing Process

Prescreening Qualified Donors

Natural biologics products are ethically sourced from mothers who voluntarily consent to donate their birth tissues at the time of delivery. This painless and risk-free collection process poses no threat to the mother or child. Donors are identified through participating obstetricians who ensure that pregnancies are normal and free from complications. Each donor undergoes a comprehensive medical evaluation, including extensive panel testing, social screening, and regulatory compliance checks to confirm eligibility. To qualify, mothers must be free from transmissible diseases such as HIV and Hepatitis, as well as active malignancies, sepsis, or systemic infections, ensuring the highest standards of safety and quality in natural biologics.

Processing and Testing

At the time of delivery, trained technicians safely collect birth tissues, which are then transported overnight to a specialized processing facility. In addition to comprehensive serological testing during prescreening, regular culturing is performed throughout processing to ensure safety and quality. Post-processing, all products undergo additional testing to confirm the absence of bacterial and fungal pathogens.

To protect cell viability while maintaining purity, trehalose, a glucoside bond, is introduced to the tissue during processing without adding excess debris. Once packed into vials, the products are sent to a third-party testing facility to verify sterility.

Every product undergoes a 14-day quarantine period, after which randomized batch testing is conducted to confirm continued sterility, absence of bacterial and fungal pathogens, and non-pyrogenicity. Before release, all test results are reviewed by a licensed medical director, ensuring the highest standards of safety, quality, and compliance.

Distribution to Your Clinical Facility

New Life ensures that all products are safely and efficiently shipped to medical facilities using validated shipping containers designed to maintain the required storage temperature with ample dry ice. Each shipment includes detailed instructions for use, product stickers, and a tissue utilization report for seamless integration into your practice. Additionally, every package contains an application guide and a quality assurance form, verifying that each order has been carefully checked for accuracy before departure, ensuring the highest standards of reliability and compliance.

Product Sourcing Process

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