The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.
The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.
At its annual meeting, the Pharmaceutical Research and Manufacturers of America elected Richard T. Clark, CEO and president of Merck & Co., chairman of its board.
One more step closer to finalization, the ISA 100 Wireless Compliance Institute presented a live demonstration of a prototype of the ISA 1001.11a wireless standard-based products at the 2008 Wireless Conference in Chongquing, China.
Also, VaxGen and Raven terminate merger agreement, Darren Head appointed CEO of Cytovance, more...
Filing risk and mitigation strategies is now a requirement for manufacturers of new drugs and biologics.
A reference book omits important information and ignores advanced testing procedures.
Essential components of a good inspection: good ingredients, proper inserts, and ... deer?
A changing regulatory environment is on the horizon for excipient suppliers and users.
Although there have been recent setbacks for China with regard to exported products, the country has made substantial strides in its pharmaceutical industry over the past few years. Intense competition and a series of new regulations seem to be moving the country into a period of recovery.
The recent heparin contamination event calls for a new approach to manage a lengthening pharmaceutical supply chain.
The FDA itself issues a cry for help. Is anybody listening?
Antibodies are highly specific molecules that can be tailored to recognize almost any stretch of peptide that nature can conjure: a feature that has been exploited for years now to produce therapeutic antibodies.
Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry.
Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.
Was FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?
The annual show provided one-stop shopping for packaging equipment and materials.
Companies continue to develop inhaled insulin and other drugs, despite the problems that Pfizer's "Exubera" experienced.
Manufacturers expect to see the latest developments in process equipment at INTERPHEX, and this year's show was no disappointment. Exhibitors regularly display additions to their lines of encapsulators, tablet presses, material-handling machines, and other automated manufacturing equipment. But the products on view in Philadelphia Mar. 26–28 were not limited to manufacturing applications.
Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.
What makes a drug ripe for respiratory delivery?
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.
