Manufacturing

The US Department of Health and Human Services's Biomedical Advanced Research and Development Authority has awarded Novartis a contract valued up to $486 million over eight years to support the design, construction, validation, and licensing of a US cell-based influenza vaccine manufacturing facility in Holly Springs, North Carolina.

The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories.

One relatively new dosage form is the orally dissolving strip, a thin film formulated with hydrophilic polymers that rapidly dissolves on the tongue.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the January 2009 edition from Clark Solutions and Neopac.

An integrated information technology environment can help pharmaceutical companies find new processes and approaches to improve manufacturing efficiency, productivity, and quality.

The US Food and Drug Administration announced that it had filed a Consent Decree on Dec. 23, 2008 and was awaiting the court?s entry of a permanent injunction that bars Actavis (Hafnarfjordur, Iceland), its officers Sigurdur Oli Olafsson and Douglas Boothe, and its subsidiary Actavis Totowa (Totowa, NJ) from manufacturing and distributing drugs at the Actavis Totowa facilities.

Also, Bristol-Myers Squibb forms collaboration with ZymoGenetics, Hana Biosciences appoints VP of regulatory affairs, more...

Also, Novozymes Biologicals settles pollution case with the US Department of Justice; EntreMed restructures management team; more...

Michigan State University researchers have discovered a technique for viewing whole cells to gain an understanding of protein inclusion bodies.

The generic-drug manufacturer Actavis reached an agreement on a consent decree of permanent injunction with the US Food and Drug Administration regarding the company?s US subsidiary Actavis Totowa LLC.

A California jury ordered Pfizer (New York) to pay $38 million to the Ischemia Research and Education Foundation (IREF), a medical-research nonprofit group, for stealing trade secrets to develop its "Bextra" analgesic.

Outsourcing sterile manufacturing involves an integrated approach in product life-cycle management.

The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.

Although its domestic market is on the rise, Pakistan's market conditions have not proved welcoming enough to keep foreign investors.

Editors' Picks of Pharmaceutical Science & Technology Innovations

The incoming administration has renewed hope for stem cells, but less adequate copycats may follow.

After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region's short- and long-term role? This article contains bonus online-exclusive material.

A book explains the many pharmaceutical applications of polymers from natural sources.

Brief pharmaceutical news items for January 2009.

The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

The USP public-comment process exists for a reason. Industry needs to take advantage. This article contains bonus online-exclusive material.

Will more resources and new leadership fix FDA, or is a major overhaul in order?

The authors propose an approach for qualification-target selection and show how it can be applied to blister-filling and packaging systems.

Instead of hampering progress, cost pressures might inspire Big Pharma to get creative.

Readers give advice on their best approach to handling (batch) rejection

The biotechnology sector is occasionally described as a rainbow, with each sub sector having its own colour. But what do the different colours of biotechnology have to offer the pharmaceutical industry?

Conflict between departments costs money, wastes time and hinders strategy implementation. But we can reduce it and manage it if we understand it, says Dr Brian D. Smith.

A new year, all things being equal, is a time of looking to the future with positive intent and traditional bonhomie. At the very least, it suggests new beginnings. As we enter 2009, however, the world is moving into a major recession and things are far from equal.

Creating better pharmaceutical and medical products with packaging partnerships.

Paul Gardiner and Andrea Sobrio explain why most companies need 'organizational polygamy' to maximize profit and best serve their customers.