Step 4: Bioconjugation
Bioconjugate molecules are a new class or generation of molecules which are designed to have an increased efficacy enabled by the combined function of two or more different therapeutic types of molecules – the sum is greater than the parts. Bioconjugate molecules can be any number of different molecule, Antibody-Drug Conjugate (ADC) one of the more common is synthesized by biochemically modifying an antibody and covalently linking it to another active pharmaceutical ingredient. – in many cases, an API which itself has already gone through chemical synthesis, isolation, purification, milling, and formulation.
Bioconjugate chemistry is a process with increasing complexity amplified with the requirement for greater scale. The tools adopted for these evolving applications 'the' round bottom flask, test tubes, magnetic stir bars, and transfer pipettes are no longer able to meet today's reproducibility demands around temperature, dosing, mixing and others. In a world of increasing regulatory complexity, statistical redundancy, and orthogonal data streams, scientists have less time & commercial leeway to repeat experiments; managers no longer have the resources to re-validate the results or host inspections resulting from regulatory deviations that could have been avoided.
Bioconjugate scientists can adopt chemical synthesis reactors. This technology brings a myriad of historically disconnected and poorly controlled operations into a cohesive architecture where data from relevant process parameters such as pH, conductivity, redox, temperature, stirring etc are captured quickly, accurately, and precisely controlled. With data integration and the advantage of overlay, process event correlation, live parameter trending, experimental integrity - reproducibility and scale-correlation are attainable. Automating the bioconjugation process can halve the process and scale up development time.