Manufacturing

As drug manufacturing and standards grow, pharmacopeias must adapt to meet new challenges.

In Part I of this article, which appeard in the March 2010 issue, the authors describe their approach for constructing form spaces for carbamazepine, cimetidine, and phenylbutazone by initial solvent screening to evaluate the feasibility of spherical crystallization. Part II of this article discusses their findings.

As the industry continues to evolve, do we know where we're headed?

An established show has several new programs that reflect the industry's current challenges.

Laboratory personnel share interesting tales as well as stories of unexpected tails.

The authors examined the disintegration and dissolution profiles of propranolol and rofecoxib tablets overencapsulated with standard hard-gelatin capsules and with capsules specifically designed for double-blind clinical trials.

Editors' Picks of Pharmaceutical Science and Technology Innovations

As demand for global vaccine development and production grows, all eyes are turning to Asia.

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

Interphex Showcase 2010.

The BIO convention, and healthcare reform, could re-energize biotech.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and types of spending made in 2009 and planned for 2010.

The authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.

Restructuring in the biopharmaceutical industry is renewing a focus on resource optimization.

FDA lacks resources to manage expanding postmarketing responsibilities.

Steve Sirabian discusses challenges, trends, and more.

Growth in the market for monoclonal antibodies, recombinant proteins, and vaccines creates new opportunities for drug companies and suppliers.

Aseptic blow–fill–seal minimizes human intervention in the packaging process.

New information improves an organization's guide to building manufacturing facilities.

In 1995, pharmaceutical regulation in Europe underwent a dramatic change with the emergence of the European Medicines Agency. The agency's 15-year history has been eventful, with it having to adapt to a changing regulatory landscape and new expectations from those relying on it for guidance.

We have recently launched a novel personalised therapy clinical trial to treat patients with late-stage colorectal cancer at George Mason University's Center for Applied Proteomics and Molecular Medicine (CAPMM). This is one of the most cutting-edge personalised therapy clinical trials in the world for several reasons including

Although holding great potential medical advances, personalised medicine will not come to fruition overnight and business models will require long-term strategies and great flexibility.

Single nucleotide polymorphisms (SNPs) are responsible for more than 80% of the variations between individuals, and are present throughout most genes and other important sequences in the human body, which makes them ideal for tracking down correlations between genotype and phenotype.

Pharmaceutical Technology Europe interviews Edward Abrahams PhD, Executive Director of the Personalised Medicine Coalition.

Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain - traditionally produced vaccines take approximately 6 months.