Quality & Regulatory - Synergy Biologics

unwavering commitment

Dedication to Quality

A key part of our mission is our unwavering commitment to the highest quality standards. Synergy Biologics is dedicated to providing safe and effective products that address unmet patient needs and exceed customer expectations, all while upholding stringent quality control standards.

We are devoted to maintaining quality and compliance at every level of manufacturing to ensure we deliver premium products, standards, and service.

Synergy Biologics

FDA Classification

Synergy Biologics 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)):

The HCT/P is minimally manipulated;
The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
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
Either:
1. HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
2. The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
  1. Is for autologous use;
  2. Is for allogeneic use in a first-degree or second-degree blood relative; or
  3. 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.

Get it straight from the source

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. All donor records and test results are reviewed internally and additionally by the Synergy Biologics Medical Director before the tissues are released. Only acceptable tissues suitable for transplant are released for use.

cGTP

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. Synergy Biologics 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.).

we care about our patients

Testing

The following tests are performed using approved methods by a CLIA certified laboratory:

Human Immunodeficiency Virus (HIV)
Hepatitis B (HBV)
Hepatitis C Virus (HCV)
Syphilis
Cytomegalovirus
Epstein Barr Virus
Human T Cell Lymphotropic Virus I/Ii
Toxoplasma Gondii
Trypanosoma Cruzi
West Nile Virus (Wnv)
Zika Virus

AATB Accredited Tissue Bank

Synergy Biologic’s manufacturing arm 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. Synergy Biologic’s manufacturing arm has successfully met these stringent accreditation requirements and is accredited for the acquisition, processing, release, storage, distribution, and donor eligibility assessment of birth tissue.

View Accreditation