Regenerative Biomaterials
Development platforms for human tissue- and blood-derived biomaterials, with capabilities spanning controlled processing, lyophilization, material characterization and custom development.
Amniotic Membrane · dHACM · Lyophilization · PRP
Core Technology Platforms
Four biomaterial development platforms covering amniotic tissue processing and platelet-derived lyophilization.
Lyophilized Amniotic Membrane
Lyophilized Amniotic Tissue Platform
Dehydrated Amniotic Membrane (DAM)
Dehydrated Amniotic Biomaterial Platform
Dehydrated Human Amnion/Chorion Membrane (dHACM)
Amnion/Chorion Tissue Matrix Platform
Lyophilized Platelet-Rich Plasma (PRP)
Platelet-Derived Lyophilization Platform
Advanced Lyophilization for Regenerative Biomaterials
A controlled development pathway from biological source material through to characterized development platform.
Human-Derived Material Quality Framework
Human-derived tissue and blood materials require additional controls depending on product type, source and destination market. The following considerations are relevant to development planning and regulatory strategy.
Donor Eligibility
Evaluation of source material eligibility criteria relevant to the intended application and destination market.
Infectious Disease Screening
Screening protocols appropriate to the biological source material and regulatory context.
Tissue / Blood Traceability
Chain-of-custody documentation from biological source through processing and final material.
Processing Controls
Controlled processing environments and validated procedures for biological material handling.
Bioburden / Microbiological Controls
Microbiological testing and environmental monitoring during processing.
Material Characterization
Physical, chemical and biological characterization of processed biomaterial.
Batch Documentation
Comprehensive batch records supporting traceability and quality review.
Storage & Stability
Defined storage conditions and stability assessment for lyophilized and dehydrated materials.
ShiLai™ positions these capabilities as development platforms. Regulatory approval status, tissue-bank licensing, validated donor programs and specific certifications are subject to project-specific assessment and are not implied by this overview.
Discuss Your Regenerative Biomaterial Project
Contact ShiLai™ to discuss development requirements, processing capabilities and project scope.
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