Manufacturing

Heparin contamination casts a shadow on regulatory oversight of product quality.

Brief pharmaceutical news items for April 2008.

Monoclonal antibodies and recombinant proteins have increased their importance and gained success as therapeutic agents in the treatment of various diseases.

Biopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture.

Manufacturing facilities must be inspected by members of regulatory bodies. However… these bodies are woefully inadequate at performing the task.

The amount of water used by industry, including pharma and biotech manufacturing, amounts to 23% of the world's supplies

As a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.

A microelectronic system based on radio-frequency (RF) cell ablation addresses limitations of other transdermal drug-delivery methods. This system expands the transdermal spectrum to include the delivery of water-soluble molecules, peptides, proteins, and other macromolecules.

Liquid and semisolid encapsulation using two-piece hard capsules is an ideal drug delivery approach for highly potent compounds and poorly water-soluble drugs. The authors detail the factors to reduce risk when designing and operating a facility for secondary manufacturing of highly potent drugs.

US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics.

In a press release, the University of Texas announced that Mauro Ferrari, of the University?s Health Science Center at Houston, presented a proof-of-concept study of a new multistage delivery system for imaging and therapeutic applications.

Also, Alkermes announces restructuring and reduction of workforce, Icagen announces several senior management promotions, more...

Scientists at the University of North Carolina at Chapel Hill have successfully tested a new inhaled tuberculosis (TB) vaccine.

Sandoz introduced its "Omnitrope Pen 5" with liquid cartridge in the United States. The product was approved by the US Food and Drug Administration and is a new form of the first follow-on version of a recombinant biotechnology drug.

As part of ongoing efforts to improve the quality of imported drug products, the US Food and Drug Administration is setting up shop in China.

Also, Pipex Pharmaceuticals implements cost-cutting measures, Pfizer's Senior Vice-President and General Counsel Allen Waxman leaves the company, more...

Hoping to provide a better understanding of its role in the heparin contamination investigations, the US Food and Drug Administration has posted a series of information sheets on its website.

This issue of Equipment & Processing Report features products from Eriez Magnetics and Netzsch Fine Particle Technology

When seeking to increase productivity, companies must consider worker–machine and worker–materials interactions. These factors are easy to overlook, but they affect workers' performance and health and a company's bottom line.

Packaging processes, like other pharmaceutical operations, benefit from the speed and repeatability that automation brings. Robotics in particular provide flexibility and accuracy. In some packaging applications such as carton loading, robotics also perform more efficiently than dedicated machines.

This year, INTERPHEX will take place in Philadelphia, Pennsylvania, on March 26?28. Equipment and Processing Report asked RJ Palermo, industry vice-president of Reed Life Sciences and INTERPHEX, to share his thoughts and expectations about the upcoming event.

The US House of Representatives Committee on Homeland Security approved legislation last week that mandates inherently safer technologies (IST) as part of chemical-site security standards, a move that was opposed by the Synthetic Organic Chemical Manufacturers Association.

Concerns over contaminated heparin product worsened as US officials announced dialysis patients in Germany have fallen ill after using a different brand of the blood thinner than was already being recalled.

Also, PDL BioPharma will no longer pursue sale of the company, executives resign from Topigen Pharmaceuticals, more...