Manufacturing

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.

Johnson & Johnson has instituted a new structure for its Consumer Group according to a Reuters report.

After completing a strategic review of options for its Capsugel business, Pfizer announced on Apr. 04, 2011 that Kohlberg Kravis Roberts & Co L.P will acquire the pharmaceutical and dietary capsule company.

The Society of Chemical Manufacturers and Affiliates criticized the Secure Chemical Facilities Act, which would require chemical facilities to use inherently safer technology as part of chemical-site security measures.

Eli Lilly and GlaxoSmithKline are among several pharmaceutical companies using technology transfer as way to improve health outcomes in the developing world.

Chemspec USA, which will be held in early May, in Philadelphia, addresses the key issues affecting the manufacturing and supply of fine chemicals.

Editor's picks of analytical instrumentation products for April 2011.

Courts and Congress seek to reshape policies and programs.

An uncertain regulatory environment affects funding for biotechnology.

Research and development may be headed for divorce.

The contract-research industry in China is growing in leaps and bounds, and Big Pharma is leading the way.

FDA reviewers aim to assist ANDA sponsors in building quality into their submissions by clarifying components of the applications. Part 4 addresses manufacture and container closure.

Regulators question whether particles that they can't see hurt patients.

PhRMA efforts of industry's R&D scientists.

The authors revisit their previous effort to refine the terms that describe interventions and to dispel confusion that arose after the original article was published.

The complexity of third-party external supply networks requires new ways to manage them.

In any industry, inspections can be a pain, and pharma is no exception.