Stringent Donor-Vetting Process
Trulacta works with milk banks that thoroughly screen donors’ blood for pathogens, sexually transmitted diseases, drugs and contagious illnesses.
Multi-Step Safety Screening
The milk banks that Trulacta works with screen donations through a 13-step, quality-control process. That process includes microbial testing, protein analysis and toxicology screening. All donations also meet federal regulations for supplements. If a donation doesn't pass each test, it is rejected by the milk bank.
Innovative BioManufacturing Process
This proprietary process kills any potentially harmful microbes and viruses without requiring pasteurization, which allows the many healthy, beneficial components in HMBs to survive.
Certificates for Biomanufacturing
US FDA Drug registration, US FDA Medical Device registration, Kosher Certification, food manufacturing license, ISO 13485 2016 (medical device) certification, 21 CFR Parts 210 and 211 (drug cGMP), 21 CFR Part 820 (medical device cGMP) and 21 CFR Part 111 (nutritional supplement cGMP).
From the Body, For the Body
All human bodies are made to recognize, accept and thrive on HMBs, the multitude of beneficial nutrients contained in human milk. Those proteins, fats, vitamins and carbohydrates are essential for human health and well-being.Clinical Research