The essence of a multidisciplinary field like biotechnology is that any company does not have all disciplines at their fingertips within the company. This is especially true for the manufacture of LBPs: while at BioLyo has considerable experience for each of the process steps necessary to develop lyophilized drug product, we cannot claim to be experts of each of these activities.
For example, while BioLyo has significant experience in growing a number of (non-)pathogenic and (an)aerobic organisms, it is impossible to know the peculiarities of for example every gastro-intestinal or skin bacterium in detail. Therefore we have a network of microbiologists and lyophilization experts that we can approach should we run into difficulties growing or lyophilyzing an organism.
Although we can develop and perform a number of assays in house, some of the equipment needed to analyze spent media in depth such as LC-MS or NMR is prohibitively expensive for a small or medium scale biotech company, so typically these types of measurement are outsourced to the University of Ghent or the Karolinska Institutet in Sweden.
For the design of the production facility, we have used Pharmadule-Morimatsu to generate a conceptual design in close collaboration with deltaPVS. In order to implement a QA system in BioLyo we have worked with both IvK Pharma Consult and deltaPVS. Regular training keeping staff updated around process characterization and GMP requirements that have an impact on how to execute the development work is essential.