Manufacturing

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."

The heightened focus on risk raises concerns about delays in approving new drugs.

While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.

Functionalized supramolecular catalysts and an enantioselective route to unnatural amino acids are some recent developments.

A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.

The authors developed a robust, automated system to conduct Karl Fischer moisture assays for lyophilized products.

The authors explain a process for moisture-activated dry granulation in detail and provide guidance for the selection of excipients and equipment.

FDA's Edwin Rivera-Martinez on dodging supply-chain challenges.

Editors' Picks of Pharmaceutical Science & Technology Innovations

New pricing controls and healthcare reforms may be pushing the pharmaceutical market out of this southeast Asian country. This article contains bonus online-exclusive material.

The authors describe the ways in which plastic prefilled syringes can be an alternative that provides consistent performance, protects drugs prone to degradation, and enhances patient safety.

The author describes how Merrion Pharmaceuticals reformulates parenteral drugs into tablets and capsules that are easier for patients to take and provide better bioavailability.

The author details the factors in formulation design, requirements in facilites and equipment, and validation criteria for aseptic formualtions.

A Conversation with Greystone Associates' George Perros. This article contains bonus online-exclusive material.

The author discusses the risks involved with aseptic processing, methods and tools used to identify and control risk, and regulatory guidelines relevant to the risk-management process.

A Conversation with Otonomy

According to a survey conducted by Pharmaceutical Technology Europe (PTE), almost 50% of you believe that cost is the biggest limiting factor to innovation in the pharmaceutical packaging industry.

Following years of development, DataMatrix codes are now a viable labelling solution for pharma manufacturers.

Michael Rubenstein, Chief Growth and Innovation Officer at Alcan Packaging, talks about applying a philosophy of sustainability to the pharmaceutical packaging supply chain.

Population ageing is an issue often discussed in the media, but its impact on all facets of life has been poorly characterized.

In 2010, Braille embossing will be required on all European pharmaceutical packages. Is the industry ready?

Apopular definition of insanity is repeating the same task over and over again while expecting a different result. It would appear, therefore, that many people in the contract services industry think the major global bio/pharma companies are insane.

What trends have you witnessed in the pharmaceutical packaging industry in the last 2 years?

Paper is no longer a sufficient format for information storage and interchange in the pharmaceutical industry; documents are inflexible and costly for production and storage.

Researchers at the University of Leicester (UK) have combined crime research and space-age technology to create a new method of detecting counterfeit pharmaceuticals. The technique, Spectral ID, works by detecting the differences between the characteristics of light reflected from printed packaging.

Mark Copley discusses the methods used for DPI testing and the challenges presented by the current regulatory framework.

With counterfeit drugs on the rise, the Chairman and CEO of Ahura Scientific discusses the issue and explains how a handheld device is helping companies to tackle the problem.

Cargill has recently announced a number of innovations connected to its range of polyol excipients.

An inhaler mouthpiece that optimizes drug delivery to the lungs and reduces the amount of wasted medication has been developed by US researchers.

Also, Astellas and Medivation sign development pact; WuXi PharmaTech appoints VP of business development, more...