Current Good Tissue Practices (CGTP) are governing methods and practices outlined by the US Food and Drug Administration (FDA). US-based tissue manufacturers are required to follow the core set of CGTP in line with their work.
Tissue manufacturers play an important role in identifying tissue cells from donors and recovering the best tissues for use in regenerative medicine techniques. Consequently, these companies are accountable to their clients’ health and should carefully implement the FDA tissue regulations.
The main aim of CGTP is to regulate the environment, equipment, and personnel of the manufacturing process of human cells, tissues, and cellular and tissue-based products (HCT/Ps) to stop the introduction and spread of contagious disease.
The FDA’s list of core good tissue practices for companies making and supplying HCT/Ps includes requirements about manufacturing facilities, donors, equipment, and personnel.
All facilities involved in producing HCT/Ps must be sized and located in accordance with FDA regulations. Ensuring a clean, safe, and efficiently-run manufacturing process can improve the final quality of the product.¹ Facilities must be undamaged, well-lit, and ventilated to minimize the risk of disease transmission.
The facility’s environment plays an important role in the likelihood of disease transmission. The regulated environmental factors include temperature, humidity, ventilation, and appropriate aseptic processing.
Facilities are required to monitor environmental conditions if there is a reasonable risk of environmental factors contaminating biological products or materials.² Some facilities monitor viable and non-viable particulates in the air, positive pressure levels, and surface sanitation.
Tissue regulation involves rigorously screening donors who offer their tissue for recovery and processing purposes. All companies producing HCT/Ps must comply with FDA written procedures, which are meant to protect future clients’ safety.
At BioStem Technologies, our donors are screened and consenting individuals. We test our donors for communicable diseases or disease agents (RCDADs), and individuals are eligible donors if their tests indicate no clinical evidence or risk factors.
Supplies and reagents must be properly validated by the company using them or the company supplying these tools. This required process checks that supplies and reagents will not increase the danger of disease introduction and transmission through a known method.³
The FDA regulates tissue recovery for regenerative medicine purposes in two ways. Tissue manufacturing companies can be registered with the FDA or use donor-recovered tissues to comply with FDA safe recovery procedures.
Proper tissue identification practice is necessary to secure the right cells and tissues at the time of recovery.
Effective and safe tissue recovery can lead to innovative medical advances, like using perinatal tissue in regenerative therapies.
In order for a cell to divide successfully, the cell must first complete DNA replication correctly.⁴ Effective processing, in turn, requires successful cell division.
The processing aspect of HCT/P manufacturing, including preparation, sterilization, and storage preservation, must take measures to prevent disease introduction and spread.
Manufacturers can promote safe processing by properly labeling, storing, and inventorying their materials and products.
If your company stores HCT/P on-site, you should regulate your storage environment to prevent cross-contamination of HCT/Ps and reagents. Additionally, storage sites should be monitored to prevent wrongful HCT/P distribution before the product is ready or safe to use.
Storage areas should be designed to accommodate the environmental controls and HCT/P quarantining necessary to provide safe products.⁵ All supplies, reagents, and HCT/Ps must be correctly labeled to avoid cross-contamination.
All equipment used in HCT/P production must comply with FDA regulations regarding their size, location, and capacity to properly expedite operations.
This equipment should be maintained, cleaned and sanitized effectively and regularly to help prevent contagious disease introduction and spread.
Strategic installation according to a pre-designed plan can improve the safety and effectiveness of operating procedures.
Although not as a core requirement, personnel regulation is mentioned by the FDA. A sufficient number of workers who are properly trained and equipped is necessary to create a safe working environment.
It is particularly important that company personnel working with allogeneic products be highly qualified, as these products are at high risk for spreading contagious diseases if not properly treated.
As a responsible and ethical company, BioStem Technologies complies with and fully adheres to CGTP. We provide perinatal tissue-derived allograft products that meet or exceed federally-regulated safety requirements to improve patient outcomes with minimal risk.
To learn more about the safety of our product manufacturing systems and how BioStem Technologies can help your patients, contact our knowledgeable staff today.
(1) Arjmand, Babak et al. “The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility.” Cell and tissue banking vol. 13,4 (2012): 587-96. doi:10.1007/s10561-011-9276-y
(2) Giancola, Raffaella et al. “Cell therapy: cGMP facilities and manufacturing.” Muscles, ligaments and tendons journal vol. 2,3 243-7. 16 Oct. 2012
(3) Allen, Lynn C. "Role of a quality management system in improving patient safety—laboratory aspects." Clinical Biochemistry 46.13-14 (2013): 1187-1193.
(4) Knoblich, Juergen A. "Mechanisms of asymmetric stem cell division." Cell 132.4 (2008): 583-597.
(5) Mutter, George L., et al. "Comparison of frozen and RNALater solid tissue storage methods for use in RNA expression microarrays." BMC genomics 5.1 (2004): 1-7.
