About Our Process
The field of natural biologics spans decades and comes in many different forms. New providers often ask us where our products come from and how we qualify donors before continuing with the natural biologic process.
New Life products are donated from consenting mothers at the time of delivery. Following all AATB, FDA, and AABB requirements, our products are safely cultivated and meet the highest quality assurance standards to be utilized in your clinical program.
1Prescreening
2Processing
3Distribution
Prescreening Qualified Donors
Natural biologic products are obtained from an expectant mother who consents to donate her birth tissues. The collection process is painless and poses absolutely no threat to the mother or her child. Donors are identified through participating OB doctors who have deemed the mothers’ pregnancies as normal and without complication. The mothers provide full consent and undergo comprehensive panel testing to determine eligibility as well as a thorough medical and social screening.
The mother will also undergo a physical exam. To be eligible to donate tissue, mothers must also be free from any transmissible diseases, active malignancies, and sepsis or systemic infections. Donating mothers must also have no known high risk for HIV or Hepatitis.
Processing and Testing
At delivery, tissues are safely collected by trained technicians. They are transported overnight to the processing facility. In addition to the serological testing in the pre-screening process, culturing is performed regularly during processing. All products are retested post-processing to ensure the absence of bacterial and fungal pathogens.
During processing, a cryopreservative is introduced to the tissue to protect cell viability.* Once packaged into vials, the products are sent to a third-party testing facility to ensure sterility.
All products undergo a 14-day quarantine period. After 14 days, the product batches are randomly retested to demonstrate a continued absence of bacterial and fungal pathogens and are non-pyrogenic. A licensed medical director reviews all testing results before the products can be released to our partnering practices for clinical use.
Distribution to Your Clinical Facility
New Life products are shipped to medical facilities within validated shipping containers containing enough dry ice to maintain the appropriate storage temperature. Included in the shipping container are instructions for use, product stickers, and a tissue utilization report to be filled out by the clinician. Additionally, the package will contain an application guide as well as a quality assurance form verifying that New Life checked each order for accuracy before departure.
*Cryopreservatives are ONLY used for cellular products and are not utilized for our acellular products.
