Purpose This study aimed to introduce a quick method for developing formulations during
the early stages of biopharmaceutical drug development, starting from the isoelectric point (p …

Therapeutic proteins can be challenging to develop due to their complexity and the
requirement of an acceptable formulation to ensure patient safety and efficacy. To date …

Therapeutic protein candidates should exhibit favorable properties that render them suitable
to become drugs. Nevertheless, there are no well-established guidelines for the efficient …

High protein titers are gaining importance in biopharmaceutical industry. A major challenge
in the development of highly concentrated mAb solutions is their long-term stability and often …

Identification of long-term stable biopharmaceutical formulations is essential for
biopharmaceutical product development. Reduction of the number of long-term storage …

Sažetak The formulation of biopharmaceutical drugs is designed to eliminate chemical
instabilities, increase conformational and colloidal stability of proteins, and optimize …

Changes in formulation may be required during the development of protein therapeutics.
Some of the changes may alter the protein higher order structure (HOS). In this note, we …

Biologics continue to play an increasingly dominant role in the modern pharmaceutical
market. The primary objective of formulation development is to efficiently deliver a …

As is the case with other pharmaceuticals, formulation development is one of the critical
steps in developing a protein as a therapeutic product. Development of stable protein …

In this study, an automated high-throughput relative chemical stability (RCS) assay was
developed in which various therapeutic proteins were assessed to determine stability based …