Newsletter | September 26, 2019

09.26.19 -- Solving Formulation Challenges In Biologics Development

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

Two of the challenges in thr 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 at Catalent Biologics outline a method of utilizing a high-throughput, microwell plate platform to economically screen a monoclonal antibody (mAb) in 96 formulations.

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 Catalent Biologics utilizes automation, specifically the Uncle platform, during formulation development.
Accelerate Biopharmaceutical Development With Novel Analytical Techniques

This article explains how using an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality, well before the final molecule is selected.

Catalent Biologics

Catalent Biologics is your one integrated partner with the expertise to get your biologic to market faster. We have the passion to help you accelerate, simplify, and de-risk your next biologic from development and manufacturing, to fill/finish, clinical supply, and commercial launch.