Outsourcing

President Obama and HHS eye innovation and countermeasures to protect public health.

The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

Novartis Sells US Enablex Rights; Ricerca Names Chemistry Director; And More.

DSM and PolyTherics in Development Deal; Kite Pharma Appoints President and CEO, And More.

Genzyme Sells Genetics Business; Bausch and Lomb Names Vice-President; and More.

Last week, Lonza (Basel) agreed to support the ongoing development of GlaxoSmithKline?s (GSK, London) biopharmaceutical pipeline by supplying manufacturing capacity for five early-stage monoclonal antibodies.

Pfizer to Acquire FoldRx; Protalix Appoints COO; And More.

Roche (Basel) launched a groupwide operational-excellence initiative intended to modify the company's cost structures and accelerate its productivity improvements.

Weighing the pros and cons of REMS for bringing risky products to market.

Company and People Notes: Lonza Acquired Vivante; PPD Appoints VP of Quality Management; And More.

A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.

Pending legislation may give FTC the authority to regulate all Hatch-Waxman settlements.

New data provide insight into pharma-industry professionals' daily lives.

Changing demands in drug development lead to new service combinations and models.

When embarking on a new outsourcing project, there are a few initial steps that must be taken to ensure a project runs smoothly from the start.

Bristol-Myers Squibb's fit-for-purpose mode for clinical-trial materials for early-stage development seeks to achieve a better way in resource allocation. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

The current trend in the pharmaceutical industry for the manufacture of small-molecule therapeutic agents is moving toward continuous flow processes. This article is part of a special issue on APIs.

In an increasingly competitive landscape, outsourcing providers are under mounting pressure to get their name out there and secure new and repeat business.

The author presents recent developments in simulated moving-bed chromatography in production of active pharmaceutical ingredients and intermediates. This article is part of a special issue on APIs.

The author explains the background behind the excipient pedigree and how to implement its use.

The economic crisis has affected outsourcing providers in several ways.

India has evolved from a low-cost region to an area with extensive technical capability and high quality standards.

Every biopharmaceutical is unique and products are defined as much by their manufacturing process as their analytical characterisation. Because of this, the development of biologics has many inherent complexities over small molecule projects.

The main advantage of outsourcing highly potent API (HPAPI) manufacture is that it eliminates the need to invest in expensive containment infrastructure, which can also be complex to engineer, install and maintain.