It was clear from the number of attendees and the broad spectrum of organizations
represented at this conference, that effective formulation development for …

The pharmaceutical formulation plays an important role in the delivery of a drug to the body.
The clinical benefit of a drug molecule can thereby be optimized by delivering the right …

This chapter addresses a critical need in biopharmaceutical formulation development that
has arisen from the shift in the drug research–development (R&D) paradigm in recent years …

INTRODUCTION Recent reviews list more than 400 biotechnology-based pharmaceuticals
either registered, in clinical trials, or undergoing review by the regulatory agencies for the …

Abstract Formulation development is an essential part of every biopharmaceutical
development program and important for the therapeutic and commercial success of a protein …

Under pressure of reduced timelines, a stronger overlap exists between drug discovery and
development, with medicinal chemists and formulation scientists often finding themselves …

While early formulation development entails screening different solution conditions (pH,
ionic strength, excipients, etc.) that confer stability to a product, late-stage formulation …

Advances in molecular biology, and of physiological and disease processes, often identify
opportunities for improving the performance of a medication. Performance enhancement …

This chapter discusses aspects and challenges related to stability, formulation, and delivery
of biopharmaceuticals. While many of the stability elements are both applicable to drug …

A drug must be formulated in a safe, consistent, and stable dosage form with proven clinical
efficacy before it can be approved for specific therapeutic indications by drug regulatory …