Turning Stem Cells into Cures
Framework for Success
The goal of the stem cell program at UC Davis is to translate research into cellular products that ultimately can be used to treat patients. One of the keys to success is an adherence to rigorous scientific and pharmaceutical standards, which are defined by a range of practices and procedures within the program.
Good Manufacturing Practice (GMP)
A national standard for the production of pharmaceuticals, as set forth by the U.S. Food and Drug Administration, that assures safe and effective drugs (see 21 CFR 210, 211). A GMP facility is under strict environmental control to assure manufacturing of sterile, potent and uncontaminated products for human therapies.
It is not enough to build a GMP facility, it is critically important that it also operate at current Good Manufacturing Practice levels. It must have standard operating procedures (SOPs) in place to ensure proper manufacturing, record keeping and retention, environmental cleaning, and facility and equipment monitoring, to mention only a few.
Good Laboratory Practice (GLP)
A standard practice that assures that laboratory research is well documented, materials can be traced exactly to their origin, and that the research can be translated into the clinic. Similar rules also apply to in vivo GLP studies (see 21 CFR 58).
Example: If a cell line with special properties to treat certain diseases was developed, every step of the generation of this cell line must be documented. The origin of the cells must be exactly known and the cells must be completely characterized and deemed safe for eventual use in humans.
Good Clinical Practice (GCP)
An international, ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
Maintaining Good Clinical Practice assures that the rights, safety and well-being of trial subjects are protected, and that clinical trials are credible.
Good Tissue Practice (GTP)
Regulations that govern methods used in, and facilities used for, manufacturing human cellular and tissue-based products. Included in GTPs are donor screening and testing, product recovery, processing, storage, labeling and distribution (see 21 CFR 1270, 1271)
How does the GTP compare with GMP?
GTP requirements are less extensive in scope than GMP requirements. They differ because GTP requirements are limited to preventing the introduction, transmission and spread of communicable disease.
GTPs are intended to ensure that products do not get contaminated during manufacturing, and that product function and integrity are not impaired through improper manufacturing.