Manufacturing

Merck and Hanwha Chemical have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel, a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.

After looking back at the first year of its Bad Ad outreach program, FDA judged that the initiative has successfully raised awareness about misleading promotion, according to an FDA press release.

The author describes the benefits and challenges inherent to cleaning in place (CIP). The article also describes the development and validation of a CIP cycle.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2011 edition from Meissner and Telstar.

Our company is getting low and unpredictable cycle life out of our diaphragm valves. This problem has caused us to implement standard operating procedures for frequent replacement of the diaphragms, which is costly and time consuming. What could be happening, and what are our options?

Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.

AstraZeneca agreed to settle a sex-discrimination lawsuit by paying $250,000 to 124 women who worked at the company's Philadelphia Business Center.

Can microdosing make medicines safer and more effective for children?

More sophisticated biological expression systems expand the functionality of the traditional systems for protein synthesis.

The authors compare three systems of single-screw extrusion using binary formulations for their suitability for producing pellets of various formulations and under various spheronization conditions.

Academic–industry partnerships are increasingly important in biopharmaceutical innovation.

Editor's picks of new manufacturing products for June 2011.

A recent industry survey shows keen interest in improving bioreactors and cell-culture media.

The study results suggested that Pluronic F127 might be a potent inhibitor of drug precipitation for Labrasol formulations.

Lessons from the earthquake in Japan show the vulnerability of the bio/pharma supply chain.

Industry struggles to curb drug abuse, diversion, and disruptions in supply.

Sometimes, there are just too many cooks in the kitchen.

A holistic approach to establishing robust control measures.

FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010.

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

Industry associations will soon provide new recommendations about extractables and leachables.

This month's BIO Convention will encourage needed conversations.

During an eight-day series of meetings that concluded on May 24, 2011, the World Health Assembly passed 28 resolutions and adopted three decisions to guide the organization?s work and address global health issues.

India's drug pricing authority increased the retail costs of certain domestically manufactured drugs, but not those of imported drug products. Pharma is asking why.

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.