The quality of the LBP is determined in the bioreactor, all subsequent process steps can only strive to maintain that quality, not increase it. In other words, in case of a live vaccine, the immunological composition or in the case of a microbiome bacterium, the metabolic activities are determined in the bioreactor as a result of the medium and the fermentation conditions used. The immunogenic make up of a live vaccine can determine whether it can adhere, colonize and induce an immune response, while the metabolic phenotype expressed in the bioreactor may facilitate successful grafting in a microbiome niche. This is the reason why we think that medium composition and fermentation conditions are key to the development of a robust process that is not only compatible with GMP but also yields a product that is more likely to be successful in a clinical trial.
BioLyo does not claim to be an expert in for example gastro-intestinal colonization kinetics, but details such as where in the GI tract the LBP is expected to colonize may affect the composition of the lyophilization buffer to be chosen. Therefore, while we try to work with standardized processes and compositions, in discussions with the client we do want to hear about the niche in which the LBP is expected to function. In other words, process development should always be a function of the activity the LBP is expected to perform, so a close collaboration with the client regarding the knowledge the client has around the LBP is strongly encouraged.