TranslateAbout Akesoe Biologics
Advancing the standard of amnion tissue care
Processing amnion-derived tissue coverings that serve as barriers and protective coverings, with comprehensive quality controls, donor screening, and reliable distribution to healthcare providers worldwide.
Our Mission
At Akesoe Biologics, our mission is to provide healthcare providers with high-quality, minimally manipulated amniotic-derived tissue allografts intended for homologous use as barriers and protective coverings. We are committed to rigorous donor eligibility determination, processing in our FDA-registered facility under 21 CFR Part 1271 and current Good Tissue Practices (cGTP), and reliable distribution.
Through ethical sourcing, validated processing methods, and a dedication to regulatory compliance, we strive to set new standards in tissue banking while expanding access to quality HCT/P products for healthcare facilities.
Key Capabilities
Registered tissue processing facilities
Advanced sterile processing technologies
Comprehensive donor screening protocols
Temperature-controlled facility storage
Dedicated regulatory affairs team
State-of-the-art laboratory facilities
Our Vision
To be a trusted provider of minimally manipulated amnion-derived tissue coverings, establishing Akesoe Biologics as a leader in tissue banking through regulatory excellence, quality processing, and comprehensive support for healthcare providers.
Rigorous Processing
Minimally manipulated tissue processing that preserves the original relevant characteristics of amniotic membrane as a barrier and covering
Regulatory Excellence
FDA-registered establishment maintaining full compliance with 21 CFR Part 1271 for HCT/P processing and distribution
Healthcare Provider Support
Comprehensive technical support and reliable distribution services for hospitals and medical facilities
State-of-the-Art Equipment
Our facility features cutting-edge equipment and technology to ensure the highest standards of tissue processing, safety, and quality control in full compliance with industry regulations and standards.
Temperature Control Systems
Regulatory Standards- Ultra Low Freezer with -80°C capability
- Panasonic -20°C Freezers, multiple units
- ABS 3 Door Refrigerator
- Pharmacy Refrigerator
- Comprehensive temperature sensor network
Processing & Laboratory Equipment
AATB Standards- Thermo Fisher Biological Safety Cabinet
- VirTis Genesis 25 EL Lyophilizer
- Accu-Seal 675TC2 Sealer
- Kanomax Handheld Particle Counter
- Air Compressor system
Monitoring & Quality Control
USP Standards- Swift Sensors monitoring system
- Omega 8 Channel Data Logger
- Temperature and Humidity Sensors, multiple units
- Ultra-Low Temperature Sensors
- Surge Pressure Differential Gauge
Environmental Control
Industry Standards- PROC-PRE environmental controls
- PROC-AMBIENT monitoring
- PRE-AMBIENT systems
- Cleanroom environmental management
- Comprehensive facility monitoring
Our Journey
From our founding to today, we've remained committed to HCT/P processing excellence through regulatory compliance and quality standards
2025: Establishment
Akesoe Biologics was established as an FDA-registered facility specializing in human cells, tissues, and cellular tissue-based products (HCT/Ps). From our founding, we have been dedicated to maintaining the highest standards of processing and regulatory compliance to serve the medical community.
Technological Advancement
As we continue to grow, our focus remains on expanding our HCT/P processing capabilities to better serve healthcare providers. We have invested in state-of-the-art facility infrastructure and advanced processing technologies to ensure compliance with FDA regulations and industry standards.
Looking Ahead
Today, Akesoe Biologics operates as an FDA-registered establishment, continuously advancing our processing capabilities and regulatory compliance to meet the evolving requirements of HCT/P processing and distribution. Our commitment to quality drives us forward.
Ready to Learn More?
Learn more about Akesoe Biologics' HCT/P processing capabilities and how our FDA-registered facility can support your healthcare institution's needs. Our team is ready to provide comprehensive information about our processing services and regulatory compliance.
