Applied Biologics Begins AATB Reaccreditation Process To Maintain High Tissue Banking Standards

Applied Biologics, a biopharmaceutical company developing biologic therapies for serious diseases with unmet medical needs, has announced the start of its reaccreditation process with the American Association of Tissue Banks (AATB), now known as the Association for Advancing Tissue and Biologics. 

The milestone marks nearly a decade of continuous AATB accreditation supporting the manufacturing and distribution of XWRAP®, the company's human cell, tissue, and cellular and tissue-based product (HCT/P). Applied Biologics is currently accredited as a tissue establishment for donor eligibility determination, tissue processing, storage, and distribution.

AATB accreditation is a globally recognized voluntary program that evaluates tissue establishments against strict standards covering donor screening and testing, tissue processing, storage, quality systems, regulatory compliance, and product distribution. The reaccreditation process involves a detailed review of manufacturing operations, quality management systems, documentation, personnel training, and an on-site inspection conducted by AATB assessors. The program is widely regarded as one of the highest voluntary quality benchmarks in the tissue banking industry.

Chief Executive Officer Edward Britt said that maintaining AATB accreditation for nearly ten years reflects the company's long-standing commitment to quality across every stage of its tissue operations. He noted that quality has remained a core principle of the organization, from donor eligibility and tissue processing to manufacturing, storage, and distribution. Britt added that as Applied Biologics continues to expand its research and development pipeline, maintaining operational excellence will remain a key priority.

Director of Manufacturing Operations Taylor Carson said the reaccreditation process requires continuous attention to quality systems, process controls, employee training, documentation, and regulatory compliance. He added that the review provides an opportunity for the company to demonstrate the strength of its manufacturing operations while reinforcing its commitment to producing products that consistently meet high industry standards.

Applied Biologics manufactures XWRAP® at its facility in Scottsdale, Arizona, under comprehensive quality systems that support the recovery, processing, storage, and distribution of human tissue. The company believes maintaining nationally recognized accreditation helps ensure consistent product quality, safety, and regulatory compliance while supporting physicians, healthcare providers, and patients.

Alongside its commercial tissue banking operations, Applied Biologics continues to expand its pipeline of investigational biologic therapies through scientific research, pharmaceutical-grade manufacturing, clinical development, and regulatory advancement, further strengthening its focus on developing innovative treatments for patients with significant unmet medical needs.