Biostem Science
Our team of Chemists, Pharmacists and Tissue Engineers work together every day to design life-changing products. They consult with practitioners, patients, and peers to collect real-time data and feedback, then alter each batch until they achieve the perfect results.
Regulations
Biostem Science utilizes FDA registered Tissue Bank which means we implement and maintain FDA regulations, prioritize legal council and perform regular internal audits. Additionally, we implement AATB standards, follow GMP guidelines, and only work with tissue procurement organizations within the United States and that follow ACOG requirements.
Sourcing
Biostem Science only accepts birth tissue donated by consenting mothers who have passed a comprehensive medical background check, blood screenings, and are full-term, live, C-section births. In addition, we only work with tissue procurement organizations within the United States who use ACOG (American College of Gynecology) collection techniques that prioritize the health and safety of the mother and baby above procurement.
Testing + Vaildation
Upon completion of manufacturing, each batch is sent away for 3rd party testing to a laboratory solely focused on donor eligibility testing and microbiology testing for transplant products.