Manufacturing

Last Tuesday, the US Senate approved the "America Invents Act," which is intended to reform the nation ’s patent system. If it becomes law, the bill will establish a first-to-file system by defining an invention ’s effective filing date as the actual filing date of the patent or patent application.

Last Thursday, FDA filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with current good manufacturing practice requirements. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until FDA determines that its operations comply with the law.

Many facilities buy compressed gas tanks or evaporate liquid nitrogen to supply processes with dry, high-purity nitrogen. An in-house nitrogen generator, however, provides several significant benefits.

Growing interest in continuous drug manufacturing has brought greater attention to in-line blending, a process that the petroleum and fine-chemicals industries have used for decades.

We are making an emulsion using a high-shear in-line mixer. It?s a 60-gal batch, and it?s taking nearly an hour to get the results we?re looking for. We have tried changing the in-line mixer?s workheads to a two-stage configuration, but it doesn?t affect the mixing time. Where are we going wrong?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Emerson Process Management and Spirax Sarco.

Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days.

AstraZeneca announced this week that it will discontinue the production of Pulmicort (budesonide) 100 and 200 µg/dose HFA (hydrofluoroalkane) pressurized metered-dose inhaler (pMDI) due to manufacturing issues related to technical aspects of the device, which prevents the ongoing manufacture of the product.

At a conference on preserving national security at the University of Pittsburgh Medical Center last week, FDA Commissioner Margaret Hamburg stressed the importance of medical countermeasures for responding to natural and deliberate threats to public health.

Compressed tablets are the most widely used solid dosage form so they must satisfy a number of physical requirements in terms of hardness, disintegration ability, friability and uniformity.

One-pot processing is a term that includes any technology that combines different unit operations of a pharmaceutical production process into one machine.

The author presents a method to calculate the relationship between supply air volume flow and airborne particle concentrations.

Moisture Activated Dry Granulation (MADG) was developed in response to the difficulties experienced with wet granulation, in terms of endpoint, drying and milling. Wet granulation process endpoint is very sensitive to granulation time and shear. The wet granules need to be dried to a narrow range of moisture contents, which is difficult. The dried granules need to be milled, but the milled granules often have either too many fines or too many coarse particles (or both) - an undesirable bimodal distribution.

In France, public confidence in health authorities and pharmaceutical industry has been shaken by a safety scandal over the drug Mediator (benfluorex hydrochloride).

The unit selected for wet granulation, whether it be a high shear mixer or a fluidised bed, has a marked impact on granule properties.

Although tablet manufacture is traditionally a batchbased wet granulation process, there are many advantages to be gained by adopting dry granulation, including lower costs and increased yields.

Tooling standardisation in the tablet manufacturing industry is a topic that has concerned tabletting professionals for decades.

Fujifilm and Merck & Co. have formed a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a contract biopharmaceutical manufacturing and development business of Merck.

Pfizer Completes King Acquisition; ViiV Healthcare Names Chairman; and More.

FDA recently sent sanofi-aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.

With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.

The 2011 show presents ideas for package designs and equipment options for packaging lines.

New product reviews from March 2011.

Indian manufacturers are not a near-term threat to Western CMOs, but may be long term.

The authors evaluated the manufacturing data of 40-mg tablets of furosemide, a potent diuretic.