Manufacturing

Reflecting the manufacturing restructuring ongoing in the bio/pharmaceutical industry, Amgen and sanofi-aventis announced the sale of manufacturing facilities to contract manufacturers.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

Johnson & Johnson's run of quality issues, recalls and other bad news continues with yet another product recall.

Merck Teams with Parexel; Roche CFO to Retire; and More

Last Friday, French daily Le Figaro reported that sanofi-aventis intended to reach an acquisition agreement with Genzyme that would value the latter company at roughly $76 per share, or a total of $20 billion.

FDA Sets Limits for Acetaminophen in Prescription Combination Products

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

GlaxoSmithKline is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

An industry expert answers a reader's question about using a volumetric dry-material feeder and jet mill to create a finished product.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

With counterfeit medicines increasingly appearing in legitimate supply chains and even in the clinical stages of product development, a recent white paper has outlined practical steps that may help companies address the issue of counterfeits and diverted products.

Last week, the US Pharmacopeia published proposed standards for the content, language, format, and appearance of prescription drug labels in an effort to enhance patient understanding and safety.

With dozens of prescription drugs soon to lose patent protection and few likely blockbusters in industry pipelines, drug developers are "aggressively" changing the way they do R&D, according to the Tufts Center for the Study of Drug Development (CSDD).

The threat of counterfeit medicines in the next year will be more severe than ever, according to a survey of 1000 companies conducted in October 2010 by Pharma IQ.

Biopharmaceuticals commonly cannot be terminally sterilised, as such aseptic processing using sterilising grade filtration is essential.

UHPLC offers increased performance compared with HPLC, including shorter analysis times and increased sensitivity.

The authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.

GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutes segment that aired on Jan. 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico.

Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

US Senator Amy Klobuchar (D-MN) urged the US Food and Drug Administration and the pharmaceutical industry to address what she called an "unprecedented" shortage of prescription drugs, especially for chemotherapy.

FDA received the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well.

Pharmaceutical Technology discusses the key issues and trends facing the pharmaceutical supply chain with Bob Kanuga, executive director of the external manufacturing organization with Merck & Co. Inc. and president of the Drug, Chemical and Associated Technologies Association (DCAT).

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

A look at manufacturing products in process control.