November 1, 2022
The discovery and development of large-molecule therapeutics is fundamentally different from the small-molecule, chemical R&D process. Biomolecule registration requires comprehensive documentation of all development and production parameters along the R&D process, including cell lines, vectors, and expression and purification protocols. Here, we present a new registration platform, developed together with major biopharma companies, which enables registration and tracking of all biologic molecules and samples. It can handle complex pools and mixtures, as well as purified materials, including antibodies, therapeutic proteins, antigens and other assay reagents, cell lines, DNA molecules like plasmids, and screening libraries. We present concrete registration applications for highly engineered molecules such as ADCs and next-generation antibodies with a focus on bispecifics. Designed to interface and integrate with existing IT infrastructures, the system can be configured to support corporate-specific variants of registration business logic such as proprietary molecule formats, uniqueness checks, or bespoke naming conventions. The platform allows sharing molecule and sample ID spaces across both large- and small-molecule applications, substantially increasing efficiency and quality along the full R&D process.