Solid State Formulation of Therapeutic Antibodies Using Spray Drying for High Concentration Reconstitution

The development of high concentration antibody solutions is being explored for use both in material logistics and storage as well as for clinical application. The design of a robust and high performing solid state formulation platform using a spray dry manufacturing process requires the optimization of spray drying attributes (i.e. nozzle selection and flow rates) and selection of appropriate formulation/excipient components including low molecular weight sugars, buffers and surfactants. Spray drying know-how and an understanding of the protein’s inherent stability can streamline the optimization of these attributes.  A historical review of research efforts in this area reveals themes around process and formulation, but a well characterized platform incorporating process, formulation, and an understanding of protein chemistry is absent.  We present a case study wherein we begin dissecting the variables important for the development of a spray dried antibody formulation with a focus on drying kinetics, excipients and protein stability.  The desirable attributes of resuspended antibody solutions that we focused on in our study included a clear solution with minimal sub-visible aggregates, while maintaining antibody integrity as compared to a non-spray dried sample.  Solid state as well as wet lab analytics were utilized in this study.  Utilizing the information accrued in this program and other similar programs we have developed a model for platform development of a spray dried monoclonal antibody formulation.  

This poster was presented at 2015 PepTalk conference in San Diego, California

Biotherapeutics / Bioprocessing