Still today, high-concentration protein formulations are often developed based on high-
throughput experimental screening approaches. Although likely delivering working …

Objective Solubility is often one of the limiting factors for high-concentration protein
formulation (HCF) development. Determination of protein solubility is challenging and …

With respect to all biopharmaceuticals marketed to date, monoclonal antibodies represent
the largest fraction with more than 48% market share (2012). However, the development of …

Early-and late-stage formulation development for biopharmaceuticals (eg therapeutic
proteins) remains a challenging task, especially when one has to select suitable excipients …

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 …

Developing high-dose biologic drugs for subcutaneous injection often requires high-
concentration formulations and optimizing viscosity, solubility, and stability while overcoming …

The purpose of this review is to demonstrate the critical importance of understanding protein–
excipient interactions as a key step in the rational design of formulations to stabilize and …

Low-volume protein dosage forms for subcutaneous injection pose unique challenges to the
pharmaceutical scientist. Indeed, high protein concentrations are often required to achieve …

Twenty years ago, a number of eminent pharmaceutical scientists collaborated on an article
describing a rational approach to developing stable lyophilized protein formulations …

Over the past few years, emphasis in drug development has shifted substantially from small
organic compounds toward macromolecules, particularly monoclonal antibodies (mAbs), to …