Manufacturing

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.

Person-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn't currently fit into traditional therapeutic manufacturing processes.

Many small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must incorporate.

Vibrational spectroscopy, which encompasses near-infrared, mid-infrared and Raman spectroscopy, is an important analytical tool in the pharma industry.

A novel personalised therapy clinical trial to treat patients with late-stage colorectal cancer was recently launched at George Mason University's Center for Applied Proteomics and Molecular Medicine (CAPMM).

Florian Krammer explains how a novel technology using insect cells can accelerate the manufacture of pandemic influenza vaccines.

The overarching aim of personalised medicines is to individualise and stratify medicines to maximise benefit, minimise harm and optimise allocation of resources (e.g., for expensive drugs).

In 2009, the BioMedical Materials (BMM) programme, the Center for Translational Molecular Medicine (CTMM) and Top Institute Pharma (TI Pharma) issued a joint call to stimulate research consortia to look for new healthcare solutions at the interface of three research areas: drug delivery and targeting, imaging and new biomaterials.

Molecular diagnostics is one of the fastest growing segments of the in vitro diagnostics market and, within this, personalised medicine is at the forefront. Personalised medicine is particularly interesting to the diagnostics industry as it represents a brand new sector for our products.