Manufacturing

The authors discuss how their research will help FDA in its identification of areas of emphasis in pre- and postapproval evaluation of products and processes.

Industry executives share insight into the future direction of drug manufacturing and the supply chain. This article contains online bonus material.

The authors conducted an experiment to determine the type of extrusion that provides the best productivity and pellet quality. This article contains online bonus material.

Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.

The authors discuss the role of quality-control automation in providing better data, enhanced compliance, and potentially faster release times.

The authors group key actions to consider when conducting a product recall and discuss how to execute them carefully and thoroughly.

Capable of great works, pharma as a whole still yields to the lesser angels of its nature.

Industry executives share insight into the future direction of drug manufacturing and the supply chain.

Developments in RNAi, monoclonal antibodies, and more are boosting the biotech marketplace.

A Q&A with Spectrum Laboratories President Tony MacDonald.

Holding product and supply-chain security to the highest standards is crucial for the future.

The manufacture of orally dissolving films is done by various methods such as solvent casting, hot-melt extrusion, semisolid casting, solid-dispersion extrusion, and rolling. The authors discuss these methods and the various parameters in which dissolving films are evaluated.

Poor organization makes it hard for readers to find the helpful information in a recent book.

Industry experts offer their best practices for dealing with deviations. This article contains online bonus material.

CDMOs and CMOs face weak economic recovery, consolidation, and globalization.

Analysis of crospovidone as a superdistingrant.

AstraZeneca and Abbott End Program; PhRMA Elects New Members; and More.

Dr. Reddy's Laboratories (Hyderabad, Andhra Pradesh, India) has entered into a technology transfer, manufacturing, and marketing agreement with R-Pharm (Moscow), a Russian pharmaceutical company.

After five years of discussions, the US Food and Drug Administration is joining the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC Scheme), known together as PIC/S.

The European Medicines Agency launched on December 20, 2010, a public registry about small and medium-sized enterprises (SME) that includes information about SME-registered companies.

Novartis (Basel) signed a memorandum of understanding with the City of St. Petersburg, Russia, confirming its intent to build a new full-scale pharmaceutical manufacturing plant in St. Petersburg.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

A US Food and Drug Administration inspection completed on Dec. 9, 2010 revealed persistent deficiencies at McNeil Consumer Healthcare's Fort Washington, Pennsylvania, facility.

A concentrated course providing the attendee an opportunity to get and keep right up to date with essential standards and best practice for cleanrooms intended for life sciences applications.

Thermo Fisher to Acquire Dionex; Former SOCMA CEO Joe Acker Dies; and More.

Abbott Laboratories (Abbott Park, IL), B. Braun Medical (Bethlehem, PA), and Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Ingelheim am Rhein, Germany), agreed to pay the United States $421 million to settle False Claims Act allegations.

Equipment and Processing Report talked to Jonathan Seville, dean of the School of Engineering at the University of Warwick, to find out how positron-emission particle tracking could help pharmaceutical manufacturers gain process understanding.

Pfizer (New York) appointed Ian C. Read, currently head of the company's global biopharmaceutical operations, as president, chief executive officer, and director. He succeeds Jeffrey B. Kindler, who retired from the company.

Company and People Notes: GlaxoSmithKline acquires Nanjing MeiRui Pharma; Cephalon's CEO to remain on medical leave; and more.

Editors' picks of pharmaceutical science and technology innovations.