The Importance of Quality Validation and GxP in Biotechnology and Research Industry

Quality validation and good scientific practices (GxP) are the foundation of high quality research results. These concepts are of particular importance in biotechnology, medical device, and stem cell research fields, where the ultimate goal is to further our understanding of human disease. As such, regulatory bodies, such as the Food and Drug Administration (FDA) are particularly interested in upholding high standards in these research areas.

What are GxP and quality validation?

GxP refers to:

Traceability
Accountability
Data integrity

Based on the product type and stage of research, the ‘x’ in ‘GxP can refer to multiple variables. These include [1, 2]:

GLP (Good Laboratories Practices)
GCP (Good Clinical Practices)
GMP (Good Manufacturing Practices)
GTP (Good Tissue Practice)

Based on the area of research, different guidelines may apply. For example, clinical research using human-derived stem cells will follow slightly different parameters than the manufacture of an FDA-approved medical device.

Quality validation ensures that time after time, the products used are consistent, from batch to batch and from the manufacture in one facility to another half way around the world. When following GxP regulations, it’s important to demonstrate that products are, indeed, both reproducible and consistent. Quality validation processes fulfill this requirement. Validation must show that products are [3]:

Accurate
Precise
Robust

Why follow GxP and quality validation guidelines?

The key benefits of these practices include:

Reproducible results
Trust in research; other teams can obtain the same results
Real world results mirror research results
Changes in location, personnel, or other parameters don’t lead to changes in research findings
Products are safe [2]
Products made in one location and country comply with guidelines and regulations required by another country

These concepts are especially important for laboratories that are required to follow GxP regulations. Research facilities and companies may face significant repercussions, including federal fines, should they be found noncompliant. At the same time, guidelines related to biotechnology and stem cell research continue to be updated to reflect evolving research and positions regarding these technologies. Keeping up with, and even ahead of, any changes to regulations saves your research organization time and resources in the event that policies undergo revision. Should you decide to move from a strictly research-specific approach to translational applications, using biologics produced in GxP-compliant facilities and following these guidelines streamlines the transition.

How does Leo Corps approach these guidelines?

At Leo Corps and our affiliative companies, we follow a strict code of ethics that maintains our work at or above any existing regulations. Many research programs are based on our raw biological products, so ensuring that variability in our biologics is minimal is critical. We consider all stages of the drug development pipeline—from how we source biological material from consenting donors to how we isolate a single cell population. Contact us to learn more.

References

GxP. 2021. Retrieved from https://aws.amazon.com/compliance/gxp-part-11-annex-11/

Webster GK, Kotts L, Maloney TD. Considerations When Implementing Automated Methods into GxP Laboratories. JALA: Journal of the Association for Laboratory Automation. 2005;10(3):182-191. doi:10.1016/j.jala.2005.03.003

Vives J, Carmona G. Guide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-Pharmaceutical Environments. Elsevier; 2016.