Standards
Quality/Regulation
Ceres is dedicated to providing safe and effective products that address unmet patient needs while upholding stringent quality control standards.
Commitment to Quality
Ceres is dedicated to providing safe and effective products that address unmet patient needs while upholding stringent quality control standards.
We are committed to maintaining quality and compliance at every level of manufacturing to ensure we deliver premium products, standards, and service.
Through ethical sourcing, responsible manufacturing, and strategic collaborations, we aim to improve patient outcomes and expand access to life-changing therapies for all.
FDA Classification
Ceres products are regulated by the FDA under 21 CFR part 1271 and section 361 of the public health service act. In 21 CFR 1271.10, the regulations identify the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria (21 CFR 1271.10(a)):
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The HCT/P is minimally manipulated;
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The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
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The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
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Either:
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HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
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The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
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Is for autologous use;
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Is for allogeneic use in a first-degree or second-degree blood relative; or
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Is for reproductive use.
If an HCT/P does not meet the criteria set out in 21 CFR1271.10(a), and the establishment that manufactures the HCT/P does not qualify for any of the exceptions in 21 CFR 1271.156, the HCT/P will be regulated as a drug, device, and/or biological product under the FD&C Act, and/or section 351 of the PHS Act (42 U.S.C. 262), and applicable regulations, including 21 CFR Part 1271, and premarket review will be required.
Patient Safety and Screening
Our quality management system adheres to the standards and regulations of both the U.S. Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB), as well as applicable regulatory bodies outside the United States. Consequently, all our products comply with Current Good Tissue Practice (CGTP) regulations.
Our quality management system ensures strict control over every step of the manufacturing process. This includes regulating recovery and processing activities and establishing standards for donor eligibility, screening, and testing. Only acceptable tissues suitable for transplant are released for use.
Current Good Tissue Practices
The FDA’s cGTP requirements regulate the methods, facilities, and controls used in the manufacture and processing of HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases. Ceres has developed a comprehensive Quality Management System that meets the requirements of both 21 CFR 1271.145 and the American Association of Tissue Banks Standards for Tissue Banking (14th Ed.).
Testing
The following tests are performed using approved methods by a CLIA certified laboratory:
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Human Immunodeficiency Virus (HIV)
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Hepatitis B (HBV)
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Hepatitis C Virus (HCV)
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Syphilis
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Cytomegalovirus
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Epstein Barr Virus
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Human T Cell Lymphotropic Virus I/II
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Toxoplasma Gondii
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Trypanosoma Cruzi
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West Nile Virus (WNV)
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Zika Virus
FDA Tissue Bank Establishment Registration
Ceres partnering facility is proudly registered with the FDA as a Tissue Bank Establishment, ensuring compliance with all federal regulations and maintaining the highest standards of tissue handling and safety.
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AATB Accredited Tissue Bank
Ceres manufacturing partner is proud to be an AATB Accredited Tissue Bank. This distinction is earned through an intensive application process, including an on-site inspection by a trained AATB inspector. The AATB verifies that a tissue bank’s operations meet or exceed their standards, ensuring that methods, procedures, personnel, equipment, and facilities comply with established requirements. The facility has successfully met these stringent accreditation requirements and is accredited for the acquisition, processing, release, storage, distribution, and donor eligibility assessment of birth tissue.
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