Good Laboratory Practice (GLP) studies are essential for generating nonclinical study data supporting drug product submissions or applications for human use. According to the most basic definition, GLP is a set of principles that can be applied to ensure the quality and integrity of non-clinical laboratory studies. GLP provides a means to standardize the results of pre-clinical studies that come from different labs, in part by imposing increased documentation requirements based on standard procedures. Standardization is the driving force behind GLP.
Given the complexity, diversity and rapid change of technology and techniques for cell and gene therapy (CGT) products, such standardization is often difficult (but not impossible!) to achieve. With key considerations, GLP studies enable investigational new drug (IND) and clinical trial application (CTA) filings and human clinical trials.
Often GLP and Good Manufacturing Practices (GMP) standards are confused or conflated. The best way to differentiate between the two is that GLP applies exclusively to the protocols and procedures for pre-clinical (pharmacology/toxicology) animal studies, while GMP applies to safe and reliable manufacture of products that are destined for use in humans. To gain further understanding of GMP, check out our “Five steps to ensure your cell and gene therapy product is GMP compliant” blog post here.
Planning is as important as execution in a GLP study
CGT developers or researchers looking to perform GLP studies should be aware that not every facility is equipped, accredited or has the right expertise to conduct GLP studies. Here are some factors to consider when planning where and how to carry out a GLP study:
- Is the facility/organization GLP accredited? In Canada, laboratories can obtain GLP compliance from Standards Council of Canada (SCC) – a monitoring authority that grants Organization for Economic Co-operation and Development (OECD) GLP recognition. In the United States there is no single form of GLP accreditation. Instead, to be GLP compliant, facilities/organizations must be able to demonstrate that they are applying appropriate FDA standards, namely 21-CFR-part 58.
- What kind of GLP studies is the facility/organization experienced in running? Not all GLP studies are created equal. For instance, carrying out a GLP study on small molecules or biologics requires different infrastructure and scientific expertise than what is required for executing a GLP study on a CGT product. For CGT developers, it is critical to understand an organization’s (CDMO for instance) prior experience with GLP studies for CGTs leading to regulatory submissions.
Considerations for complex GLP studies
One of the main reasons for carrying out a GLP study is to provide regulators with evidence to support CTAs in Canada, and IND applications in the United States (for example). However, it is not always feasible to perform studies under GLP conditions and, in some cases, regulators may be willing to consider high-quality, reliable data obtained under non-GLP conditions (see FDA’s Preclinical Assessment guidance here). Given the lack of clarity between GLP and “GLP-like” studies, the criteria for what constitutes, and when and where to execute such studies, should be based on an informed decision in collaboration with scientific experts, experienced CDMO and regulatory authorities.
In general, there is a need to clarify the concept of GLP in the CGT space, and greater education and resources are important in advancing the field. By choosing a specialist partner with scientific and regulatory expertise, along with prior experience in conducting preclinical laboratory studies, bottlenecks in development of CGT products can be easily avoided.