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What quality grade labeled compounds do you need in your trials?

Maarten Brom, PhD

Your drug development phase determines whether you need a laboratory, GLP or GMP grade labeled pharmaceutical.

Laboratory quality grade labeled compounds in early-stage development.

Laboratory grade materials are sufficient to conduct early-stage in vitro experiments. Namely, to evaluate the potency, efficacy, and target binding of your drug candidate. Laboratory grade materials include anything from buffers to disposables to lead compounds. Even the materials for the manufacturing of the lead compound can be laboratory grade.

In general, the purity of laboratory materials is lower than materials used in clinical trials. Further, both the manufacturing process and quality control of the product tend to be based on local regulations. As the manufacturing process does not have to comply with strict international rules, the traceability of the manufacturing process less reliable.

Nevertheless, the quality of your compound and the reproducibility of your manufacturing process remain important to obtain robust and reproducible results. Besides manufacturing of the compound, this also applies to the execution of the preclinical in vitro and in vivo experiments.

Why would you use laboratory grade materials? Laboratory grade materials are cheaper and faster to produce. Making it a time- and cost-efficient option for your early research where flexibility is a must.

Translational phase: from laboratory to GLP quality grade labeled compounds.

After your in vitro and in vivo evaluation show positive results, you can initiate the translation of your new compound for use in clinical trials. This means that you explore the possibility to produce your labeled compound for clinical use. You can also examine the toxicity of the compound in animal toxicology studies.

For these preparational activities the quality of the labeled compound is key. The compound you use in this phase should be highly similar to the labeled compound you want to use in clinical trials. That is why your activities should be executed under Good Laboratory Practices (GLP).

GLP is a quality system that guarantees and promotes safety, consistency, high quality, and reliability of products in the process of non-clinical and laboratory testing. Besides compound production, GLP can also be used for things such as conducting animal toxicity tests.

It is crucial to adhere to qualified GLP protocol. If done correctly, the level of documentation and traceability becomes higher than in the previous R&D phase. However, even though the quality level is high, the products manufactured in a GLP facility are not for human use.

GMP quality grade labeled compounds for early-stage in-human clinical trials.

Your labeled compound needs to be of the highest quality level for clinical trials. In other words, all chemicals have to be approved for human use. Additionally, all your quality controls, equipment and facilities must be validated and qualified for the preparation of compounds for human use. The quality of your products should adhere to guidelines set by national and international agencies such as the FDA and EMA. To comply to these guidelines, you need to follow good manufacturing practices (GMP).

GMP guidelines describe manufacturing requirements that ensure the quality of a product. The manufacturer must make sure and show that the quality is consistent from batch to batch and for the intended use. This requires thorough documentation of the manufacturing process. Moreover, the manufacturer must ensure and provide documentation that personnel is properly trained. They must also check the quality of a product at many phases of the production process. So, not just check the end-product. To safeguard adherence to GMP, the use of an effective quality management system (QMS) is a key asset.

How do you choose the right quality grade for your drug development phase?

Obviously, GMP-grade material is of the highest quality. However, this high quality and need for high quality materials, facilities, and controls make it significantly more expensive and time-consuming to produce.

Thus, for early preclinical experiments GMP material is not required and laboratory grade material is sufficient. This is more cost-efficient and compatible with the experimental nature and flexibility of early preclinical trials. Once preclinical experiments will be used to support the potential use in clinical trials, a higher quality standard is needed. Therefore, GLP should be considered, especially in the case of animal toxicity studies. For clinical use the production under GMP is required and mandatory.

It is good to be aware that in all phases of (clinical) research you must ensure high quality and reproducibility to generate reliable research data. Therefore, the quality of your compound should be “phase appropriate” and of the highest possible quality to ensure the most efficient and reliable translation for in-human use.

At TRACER, we can help you with the translation of labeled and unlabeled GLP- and GMP-produced compounds for use in early-stage clinical trials and consecutive Phase 1 and 2 clinical trials. We can advise you on the most efficient and reliable route to first-in-human application for the delivery of robust and reproducible data and the quality standard of your labeled compound appropriate for the development phase of interest. Contact us here.

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