Manufacturing

FDA, NIH and industry seek new strategies to spur drug development and promote access to therapies.

Can the semiconductor industry help Big Pharma develop therapies?

Innovator and generic-drug companies need to adapt to compete in the biosimilars market.

Many factors affect research results.

Despite initiatives to encourage multinational pharma companies to conduct R&D in the UK, the country may be losing its edge; is Pfizer's decision to exit a key site earlier this year the beginning of a mass exodus?

The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.

The authors discuss various approaches and related issues, including production of difficult-to express proteins using cell-free expression systems, scalability of protein expression, and site-specific chemical modifications.

Traditionally, lot Numbers and expiry codes or dates that appear on cartons have been considered as an add-on to the cartoning process rather than an essential element in their own right.

The author reviews the state of downstream processing and considers potential solutions, including the streamlining of full processes and borrowed technologies.

The authors provide further insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.

Results from our annual survey. This article contains online bonus material and is part of a special issue on Bioprocessing and Sterile Manufacturing.

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.

The author describes recent developments to help overcome the downstream processing bottleneck. This article is part of a special issue on Sterile Manufacturing and Bioprocessing.

Linking peptides to polyethylene glycol, or PEGylation, has helped improve pharmaceutical therapeutics in several ways. A wave of new techniques is now ushering in further advances.

A technical forum moderated by Patricia Van Arnum

Shanghai Pharmaceutical and Pfizer have signed a memorandum of understanding for the companies to jointly pursue potential business opportunities in China.

GlaxoSmithKline (GSK) identified certain over-the-counter (OTC) brands in its consumer healthcare business that the company plans to divest.

Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

On Tuesday, Apr. 19, 2011, officials from FDA, the US Department of Health and Human Services, and the Drug Enforcement Administration introduced President Obama?s plan for curbing prescription-drug diversion and abuse.

The implementation of digital photomicrography has expanded the capabilities of microanalysis for quality control. But if used incorrectly, the technique can hurt more than help.

We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the April 2011 edition from ACS Valves and L.B. Bohle.

To find out how well industry is applying QbD, and what benefits the approach can bring, Equipment and Processing Report talked to Moheb M. Nasr, director of FDA?s Office of New Drug Quality Assessment.

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

Merck & Co. has formed a joint venture with the Mumbai-based specialty pharmaceutical company Sun Pharmaceutical Industries to develop, manufacture, and commercialize new combinations and formulations of branded generic drugs in emerging markets.