Newsletter | May 21, 2020

05.21.20 -- Tips For Delivering Biologics Therapies To Market Faster

High-Throughput Preformulation Development Platform For Biologics
Typically, in early development, the quantity of protein available for studies is limited, and a dataset 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.
Enable Oral Delivery Of Synthetic Oligosaccharides

Due to their poor oral bioavailability, oligosaccharides — along with most pharmaceutical macromolecules — are formulated as solutions or suspensions and delivered by invasive intravenous (IV) or subcutaneous injection. This case study demonstrates how OptiGel Biotechnology significantly increases oral bioavailability of a synthetic oligosaccharide, thus enabling oral conversion.

Rapid Global Characterization Of Immunoglobulin G1 Following Oxidative Stress

This article describes a method for rapid and consistent global characterization of leachable metals or peroxide-stressed immunoglobulin (Ig) GI monoclonal antibodies (mAbs). Applying this new method to stability studies will promote a broader and deeper understanding of stress modifications on therapeutic proteins.