At Elava Bio, we are committed to revolutionizing regenerative medicine with innovative solutions that preserve and maximize the use of donated human tissue. Quality and compliance is at the core of everything we do. We strive to provide the highest quality and safest donated human tissue for our domestic and international processing partners. All while ensuring that every donated tissue is put to good use, heal patients and save lives. ​​​​​​​​
Services & Solutions
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We provide a full range of tissue storage and distribution services for our domestic and international partners. All while upholding strict FDA regulatory standards for tissue handling. Our diverse donated human tissue offerings include;
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Placental tissue
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Dermis
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Bone
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Other allograft materials​​​
Temporary Tissue Storage
Tissues are stored at -80C freezers with 24/7 monitoring for maximum security.
International Distribution
For international partners, we offer end-to-end support, including shipping logistics, customs clearance, AATB accreditation guidance and regulatory compliance assistance.
Validated Shipping
Tissue is packaged in secure, validated shippers filled with dry ice, ensuring temperatures of at least -40°C are maintained throughout transport.
Research & Development
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We collaborate with our processing partners to advance innovative tissue-based therapies. Our research and product development services are designed to support cutting-edge technologies in regenerative medicine.
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Through these initiatives, we remain at the forefront of advancing solutions that improve patient outcomes worldwide.
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Harvesting and expanding placental tissue-derived mesenchymal stem cells (MSCs)
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The concentration and purification of exosomes
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Umbilical cord tissue product development
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Other emerging tissue regenerative applications
Tissue Safety
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At Elava Bio, safety is our top priority. We pride ourselves on exceeding regulatory safety standards through rigorous quality processes and comprehensive third-party laboratory testing.
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All donor blood samples collected at the time of recovery are tested by a CLIA-licensed and FDA HCT/P-registered laboratory.
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Testing includes:
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Hepatitis B (surface antigen and core antibody)
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HIV 1/2 antibody
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Hepatitis C antibody
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Syphilis
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HIV-1 NAT, HCV-NAT, and HBV-NAT
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All serological antibody and NAT test results are confirmed negative prior to release for storage or distribution.
Quality Compliance
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Quality is at the core of everything we do. We are committed to providing our domestic and international processing partners with the highest quality donated human tissue, ensuring that every donation meets all donor eligibility requirements.
Our operations are conducted in full compliance with;
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DA regulations published in 21 CFR 1270, Human Tissue Intended for Transplantation
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*21 CFR 1271, Donor Eligibility Final Rule – Subpart C
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American Association of Tissue Banks (AATB) Standards
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Through strict adherence to these regulatory frameworks and standards, we maintain a reliable, safe, and ethically responsible platform for the storage and distribution of donated human tissue.