Drug Development

USP optimizes identification tests and impurities procedures.

Development of viable dosage forms for poorly water-soluble compounds continues to be a significant challenge for formulation scientists, and insufficient bioavailability of such compounds may result in development delays or failures.

The authors describe a solid form technology platform used to optimize salt selection, cocrystallization identification and modification, or the development of a free form.

Pfizer has two manufacturing facilities in Germany for high-potency manufacturing, respectively in Freiburg and Illertissen. Pharmaceutical Technology's Executive Editor Patricia Van Arnum visited the facilities and spoke to the company about the design and operation of these facilities.

The authors describe a QbD study that was performed to optimize a coating system.

A Q&A with BASF moderated by Patricia Van Arnum.

Rob Blanchard and Clive Roberts discuss the issues surrounding tablet sticking.

The authors explain chemical transformations that are achievable through certain biocatalytic routes.

An industry roundtable representing Metrics, Cambrex, Carbogen Amcis, Euticals, Ferro Pfanstiehl, and SAFC.

Approaches to scaling up API syntheses center on ways to optimize process conditions and operability.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Enhancing bioavailability can be achieved through hot-melt extrusion or spray drying. Patricia Van Arnum interviews Bend Research to find out more about when to use each technique.

Meticulous system configuration can prevent machines from taking over.

The author provides results and commentary on a survey analyzing outsourcing strategies, practices, challenges, and outcomes in the selection of a CRO.

The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.

Dedong Wu, senior scientist at AstraZeneca, explains how nanoparticle engineering and crystal engineering can aid solubility.

A complete and unedited audio slideshow of the Excipient Fest roundtable on atypical visible particles

Flow chemistry and microreactors offer an alternative to traditional batch manufacturing.

Holistic open learning networks offer a new drug R&D model for improving research outcomes.

Jim Miller, president of PharmSource, examines the future direction of CROs/CMOs and the factors influencing the pharmaceutical contract services sectors.

The past three decades have driven a purchasing evolution to a procurement revolution.

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

Tracking changes from spinoffs of chemical companies to life-sciences powerhouses.

Readers point to quality by design as having a significant influence on manufacturing and drug development during the past decade.

Companies roll out expansions in manufacturing high-potency APIs and finished products.