Manufacturing

Strong growth in biopharmaceuticals bodes well for contract manufacturing, but the perils and the promises of pipelines remain.

The president of BIO proposes the ingredients needed for industry growth.

Process steps, GMP documents, a purification vessel, and validation seem to disappear.

The authors describe the importance of a rapid and an abbreviated screening strategy by initial solvent screening in 20-mL scintillation vials.

The Japanese government is eager to jumpstart its generic-drug market, but changes must come first.

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

Brief pharmaceutical news items for May 2009.

Taking a cue from its electronics industry, Taiwan is seeking to put its biotechnology and pharmaceutical industries on the map. An interactive map shows pharmaceutical activity in Taiwan.

Government funding is slated to boost comparative studies of prescription drugs.

Manufacturers of therapeutic monoclonal antibodies consider new paradigms in purification technologies.

Products at INTERPHEX focused on protection, compliance, and deterring counterfeiting. This article contains bonus online-exclusive material.

The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

Technology can solve enterprise-level problems.

Editors' Picks of Pharmaceutical Science & Technology Innovations

The CRO market is experiencing two-tiered growth: firstly from pharmaceutical companies seeking to lower fixed costs by outsourcing clinical research to CROs; and secondly, from biotechnology and specialty pharmaceutical companies that lack the infrastructure to conduct trials.

Bulk Inspection of Tablets-Symetix Application Note

The identification of an increasing number of drug targets coupled with advances in manufacturing technology could lead to many more blockbuster therapeutic antibodies.

A novel cleanroom apparel design incorporates modern concepts to help minimize contamination. Take a tour of the design.

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.

The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.

The author provides a history of the information chapter USP ‹1211› "Sterilization and Sterility Assurance of Compendial Articles," from the early 1900s to the current version.

A Pharmaceutical Technology survey examines capacity expansions, outsourcing practices, innovation levels, and the role of quality by design in sterile manufacturing and aseptic processing.

The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them.

Also, Roche's Avastin trial does not meet endpoint; Innate Pharma names regulatory VP; more...

Senators Chuck Grassley (R-IA) and Ted Kennedy (D-MA) introduced legislation last Thursday that would give the US Food and Drug Administration more resources to inspect domestic and foreign plants that manufacture drugs and medical devices.

Global market research firm IMS Health issued a disappointing report last week regarding the state of the pharmaceutical market.

The Pharmaceutical Research and Manufacturers of America released a statement this week in response to recent media reports regarding the amount of pharmaceutical ingredients being discharged by manufacturing facilities into the environment.

Also: Sanofi-aventis acquires BiPar Sciences; FDA issues Warning Letter to Chinese heparin manufacturer; Halo Pharmaceutical appoints chief scientific officer; more...

Pharmaceutical giants GlaxoSmithKline (GSK) and Pfizer announced on April 16, 2009 that they are joining forces to create a new HIV-focused drug company.

The United States Pharmacopeial (USP) Convention signed a memorandum of understanding (MOU) with the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) last week in Moscow.