AABB Introduces New Cell and Gene Therapy Standards for Pharmacy
November 18, 2024
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Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to introduce the proposed first edition of Cell and Gene Therapy Standards for Pharmacy, available for public comment through Dec. 16. These new standards represent an important advancement in ensuring the highest level of quality and safety for cell and gene therapy (CGT) products.
As more and more CGTs gain approval, pharmacies are becoming key players in managing these complex, high-value therapies. A review of existing pharmacy quality programs and available certifications revealed a lack of standards for handling and managing CGTs within pharmacy.
Developed through an expert committee of diverse academic and industry stakeholders and drawing on AABB’s expertise and history in quality system creation, AABB’s Cell and Gene Therapy Standards for Pharmacy will guide pharmacies in the receipt, storage, handling and dispensing of these therapies. The program intends to assist pharmacy programs in enhancing patient safety by filling a critical gap in accreditation while addressing business risks by ensuring product integrity while in possession of a pharmacy.
The Cell and Gene Therapy Standards for Pharmacy Committee encourages all interested individuals to submit comments by Dec. 16. The draft first edition of standards will be finalized after the comment period has concluded. The committee will review all comments submitted and provide a summary document that describes the committee’s rationale for its final decisions.
About AABB Standards
AABB is the leader in setting standards that optimize and advance quality and safety for the blood and biotherapies field. Since 1957, AABB standards have been the backbone of AABB’s mission. AABB standards are currently applied to AABB-Accredited facilities in more than 50 countries and other facilities to advance their quality and safety measures.
AABB Standards combine internationally accepted quality management system requirements with relevant technical requirements for each discipline. AABB Standards are based on AABB’s quality systems essentials, which leads the field in quality standards worldwide. AABB standards incorporate both technical and quality systems standards to ensure that all facets are reviewed – from specification of equipment, materials management and organizational structure to documents, resource management and program assessment. Each edition of AABB’s Standards is developed by a team of experts who volunteer their time as a member of a Standards Committee. Each edition of AABB’s Standards is based on best medical practice, scientific data, and quality assurance, and applicable regulations. Each revision cycle includes a public comment period that seeks input from active professionals throughout the world. For more information and a list of current AABB Standards visit www.aabb.org/standards-accreditation/standards.
About AABB
AABB (Association for the Advancement of Blood & Biotherapies) is an international, not-for-profit organization representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The Association works collaboratively to advance the field by developing and delivering standards, accreditation, and education programs. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available, and effective worldwide. For more information, visit www.aabb.org.
4550 Montgomery Avenue Suite 700, North Tower Bethesda, MD 20814
301.907.6977 www.aabb.org
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