Newsletter | October 15, 2020

10.15.20 -- Considerations For Formulation Development In Biologics Production

Developing A High-Throughput Formulation Development Platform For High-Concentration Therapeutic Monoclonal Antibodies

Two of the challenges in the early stages of a pharmaceutical are a limited supply of protein to use in formulation screening studies and a need to obtain stability data quickly to initiate tox studies. In this poster, scientists outline a method utilizing a high-throughput, microwell plate platform to economically screen a monoclonal antibody (mAb) in 96 formulations.

High-Throughput Preformulation Development Platform For Biologics

Typically, in early development, the quantity of protein available for studies is limited, and a data set is required to expedite tox- and IND-enabling stability studies. In this study, a high-throughput formulation development approach for sample preparation and sample analysis was implemented in order to enable a simple and less labor intensive screening of a broad range of conditions in considerably less time.

A Strategy To Remove Formulation Development From The Critical Path During Biologics Development

Conducting a pilot formulation study at the early drug substance development stage can make things considerably easier at the manufacturing stage. Read how researchers utilize automation, specifically the Uncle platform, during formulation development.