Through a 5-year development cycle, ELOGE was considerably expanded to integrate fine grain modelling of wet lab routine procedures such as plate management, PCR quality control annotations, sequencing results, analytic validation, and GLP (Good Laboratory Practices) compliant protocols.
The C-tag technology has the potential to form the basis of a current good manufacturing practice-compliant platform, which could greatly improve the speed and ease with which novel protein-based products progress to clinical testing.
Not only can this fluorophore be efficiently conjugated to antibodies, smaller antibody fragments, or nanoparticles [7 11], but more importantly, this fluorophore is already available at a good manufacturing practice-compliant production grade for clinical studies (since September 2010, LI-COR communication, [12]).
Until recently, patent protection on morpholino synthesis restricted the production of Good Laboratory Practice-compliant PMOs, and production facilities at this point in time are limited.
Alternatively, the good manufacturing practice-compliant maturation cocktail that we use may be of such a strength that is not amenable to inhibition by these agents.
This preclinical study used Good Manufacturing Practice-compliant components to generate both LAKs and DCs, to ensure translational relevance for application in human clinical trials.
While it is very helpful to have good clinical skills, the research skills necessary to be a Good Clinical Practice (GCP) compliant clinical trialist or to effectively run a GCP compliant clinical trial site are separate from the basic skills required for clinical practice.
All sample analyses were conducted in the Good Laboratory Practice (GLP) compliant lab at SomaLogic by trained staff as described [ 51].
