Tailored Data Management and Analysis for Biologics R&D
Abstract:
The increasing automation of the discovery and development process for therapeutic antibodies and recombinant proteins requires new software solutions to store and interpret the experimental data that are generated along the R&D process. For this, we have interviewed over 100 individuals from six different biopharma, biotech and contract manufacturing organizations (CMOs) in the US and in Europe to identify today’s most pressing informatics needs for a more efficient biologics R&D process. These individuals included screening scientists, assay developers, molecular biologists, protein scientists and engineers, analytics scientists, process engineers, laboratory and department heads, laboratory technicians, and research IT experts. We identified major differences of the biologics domain that make existing informatics solutions for small molecule drug discovery not applicable or at least not easily adaptable. In collaboration with our partners, we have developed tailored software that incorporates biologics domain knowledge, recognizing the importance of protein and nucleotide sequence data, as well as the importance of modeling the full processes involved in producing proteins. Here, we present a selection of novel tools and databases for antibody screening, antibody engineering and biologics registration that address real-life needs in the laboratories that are often overlooked by current commercially available software.