Manufacturing

A recent book offers an excellent overview of cleaning validation.

IP rights and levels of innovation have opened a bit of controversy regarding decisions being made by Indian courts and legislators.

An analysis of the approaches and tools used to tackle the problem of poorly soluble drugs.

A conversation with Mike de la Montaigne, president of Eisai Machinery, USA Inc., about the possibilities for conducting fully automated product inspections.

As technology advances, industry's needs are growing.

Scientists and practitioners must work together for the overall good of the patient.

A new center may provide evidence for improving care, but could discourage coverage of treatments.

The authors describe the development of an inclusion complex of GLZ and formulated an extended-release dosage form based on osmotic technology.

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

The authors demonstrated that ODTs can be obtained by direct compression of a mixture of starch, fructose, and SMCC.

Post recession and beyond, which contract service providers will still be standing?

Connecting science and policy might increase support for innovation.

Used packaging equipment can be a cost-saving, time-saving alternative to new machines.

Stuart Needleman, president of active-ingredient development and manufacturing at Aptuit, discusses industry trends and challenges.

The author reviews key considerations for formulating powders for use in inhalers. This article is part of a special Drug Delivery issue.

Product integrity issues in the global pharma market are a hot topic at the moment and many companies are reviewing and increasing their quality control procedures.

The authors describe an alternative approach to compressing and coating minitablets for use in a sustained-release, solid oral-dosage form. This article is part of a special Drug Delivery issue.

The author outlines how to choose carriers and capsule shells according to dosage requirements and intended use. This article is part of a special Drug Delivery issue.

Robots are becoming faster, cheaper and smaller. In pharmaceutical packaging applications, robots are often used at the end of the process — either in the primary packing of product into small packs, or further downstream product packing into cartons and subsequent palletising.

The author reviews advances in technology that may soon allow transdermal delivery of two of the fastest growing drug classes on the pharmaceutical market. This article is part of a special Drug Delivery issue.

Leading European experts from the pharmaceutical packaging industry explain how they are coping with industry trends.

Discussing the key challenges that face cell-based bioprocess manufacturers today, how these challenges might be addressed and the innovations that could facilitate the process in the future.

Although there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.

This article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.

Generally, the pharma industry isn't doing enough to reduce the environmental impact of its packaging materials, but there are various historic reasons for this.

PPD and Bend Research Form Collaboration; Ricerca Makes Senior Appointment; And More.

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

Genzyme has outlined why it believes sanofi-aventis's tender offer of $69 per share "dramatically undervalues the company" and why a price of $89 per share would be more reflective of the company's true value.

Puerto Rico's Governor Luis Fortuno unveiled a fiscal reform package in Puerto Rico this week as part of economic development and budget-deficit reduction plan for the commonwealth.

A European pilot initiative will test the impact of consultations with a number of stakeholders such as patient representatives and payers on early-stage drug development.