Berkeley Biologics LLC

Berkeley Biologics is a tissue bank and contract manufacturer specializing in human allograft implants for orthopedics, spine, sports medicine, trauma, dental, and wound care. The company has 35+ years of expertise in tissue processing and transplantation. Core product lines include D-FIBER (demineralized cortical fiber matrix for bone regeneration), AcelloDerm (pre-hydrated acellular dermal matrix), AltiPly (lyophilized placental membrane for wound care), InteguPly (acellular dermis for sports medicine and wound repair), and TranZgraft (processed allograft tissues including tendons and ligaments for sports medicine). All products undergo rigorous donor screening, communicable disease testing, and quality assurance per AATB and FDA standards. Berkeley Biologics processes tissues using proprietary methods including low-dose e-beam irradiation and gamma sterilization to achieve sterility assurance level (SAL) of 10-6, while preserving native matrix structure, collagen integrity, and endogenous growth factors (BMP, FGF, IGF-1, PDGF, TGF-β). The company operates state-of-the-art manufacturing facilities in Northern California and offers turnkey contract manufacturing, private-label allograft opportunities, custom implant development, engineering and validation support, and inventory management services. Regulatory compliance includes FDA registration (21 CFR Parts 820 and 1271), AATB accreditation, and tissue bank licensure in California, Florida, Maryland, New York, Delaware, Illinois, Oregon, and Canada (CTO registration). The company serves surgeons, hospitals, and surgical centers across multiple specialties.