Manufacturing

Mystic, CT (Oct. 26)-Kenneth G. Chapman died at his home here on Oct. 26. He was 79. The cause was pancreatic cancer

Research Triangle Park, NC (Nov. 13)-Eisai Inc. broke ground here for a new pharmaceutical production and formulation research and development facility for parenteral oncology drugs.

AAPS, San Antonio (Oct. 31-The advantages of ultra-performance liquid chromatography over traditional high-performance liquid chromatographic were the center of the presentation, ?Strategies for Rapid Chromatographic Method Development from Preclinical to Phase 3,? by Charanjeet Jassal of Wyeth Pharmaceuticals.

Geneva, Switzerland (Oct. 23)-Aiming to increase capacity for producing influenza pandemic vaccines, the World Health Organization has identified strategies and practical solutions for reducing the anticipated gap in the global vaccine supply.

Dublin, Ireland (Nov. 6)-Merck Sharp & Dohme (Ireland) Ltd., a wholly owned subsidiary of Merck & Co, Inc. plans to establish a formulation-research-and-development and manufacturing facility at its plant in Ballydine, Ireland, according to the Industrial Development Agency Ireland.

Akorn, Natco, Illumigen, Avecia

AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.

South San Francisco, CA and Basel, Switzerland (Nov. 8)-Genentech, Inc. and the contract manufacturer Lonza Group entered into an agreement under which Lonza will buy Genentech's mid-scale mammalian biopharmaceutical manufacturing facility in Porri?o, Spain, supply certain products to Genentech, and provide Genentech with the option to purchase Lonza's planned biopharmaceutical manufacturing facility in Singapore.

AAPS, San Antonio (Oct. 30)-Although the analysis of impurities in drug substances and drug products is not a new topic, new regulations are increasing concern in the industry.

AAPS, San Antonio (Oct. 31)-As biologic-based drugs become an increasingly larger part of pharmaceutical product portfolios, strategies for optimizing their formulation become increasingly important.

AAPS, San Antonio (Oct. 30)-Aiming to provide a greater understanding of coating processes, speakers at the 20th Annual Meeting of the American Association of Pharmaceutical Scientists presented some of the difficulties, tools, and strategies for obtaining adequately uniform films in pan and fluid-bed coating processes.

San Antonio, TX (Nov. 1)-Though the US Food and Drug Administration's final guidance on process analytical technology (PAT) was published in Sept. 2004, companies are still unsure about how exactly to implement PAT in their processes.

San Antonio, TX (Nov. 1)-The opening session of the ?Pharmaceutical Technologies? track at the 2006 Annual Meeting of the American Association of Pharmaceutical Scientists in San Antonio, Texas was standing room only as R. Christian Moreton, PhD, vice-president of pharmaceutical science at Idenix Pharmaceuticals, and Richard O. Mannion of Purdue Pharma discussed ?Product Development Using a Virtual Company Model.?

Mid-size regional players have little chance for success in an industry increasingly dominated by large global players.

Mid-size regional players have little chance for success in an industry increasingly dominated by large global players.

FDA must monitor a growing number of facilities and complex drugs despite "resource challenges."

Branded pharmaceutical companies have long been immune to the cost pressures faced in other industries. With robust research and development pipelines, long periods of patent protection to ensure continued high margins, and a regulatory environment that has virtually eliminated the threat of overseas competition, pharmaceutical companies have traditionally considered spend management an afterthought. Recent changes in the pharmaceutical industry, however, have begun to erode Big Pharma's once-imperious position.

Understanding the impact of reactive mass transfer and local flow in multiphase systems is crucial for maximizing reaction selectivity and minimizing the formation of byproducts. The authors study the influence of mixing on fast liquid–liquid reactions. The iodination of L-tyrosine was used to demonstrate the relationship of droplet size and shape on reaction selectivity and to verify computational predictions. By understanding that droplet dynamics affect the yield and selectivity of fast reactions, the formation of byproducts can be minimized by optimizing operating parameters.

The trend towards developing pharmaceutical products and their manufacturing processes in tandem supports optimized production. Such developments rely on gathering process-relevant information at an early stage and being able to draw on past and current processing experience. Here, we discuss how powder rheometers can make a real difference in building a database of powder properties and removing subjectivity.

Clean rooms are critical areas in bio/pharma facilities, and it is essential that users are responsible for their care and upkeep, and familiarize themselves with the relevant regulations.

Quality by design and PAT approaches are increasingly being used for the biotech manufacturing of medicines. Complex manufacturing processes can not only be controlled using PAT principles, but optimized with respect to both product quality and economic value. This column describes how the fermentation process is often the first to benefit from this type of implementation.

The ¤9.5 billion therapeutic antibody market comprises over a dozen antibodies that have been generated using recombinant genetic methods developed over the last 20 years.

This article examines what other industries have done to address the challenges associated with successfully implementing the principles and concepts of process analytical technology, particularly the specific elements of measurement, analysis, and control. The author explores how other industries' approaches can be applied directly to pharmaceutical manufacturing.

Modeling conducted in the process development and early commercialization stages can increase process efficiency and lead to process-control improvement. A virtual plant environment, running on a PC, can incorporate the same industrial control systems and configuration expertise used in manufacturing and helps many parts of process analytical technology. It also can make possible the enlightened use of technologies such as model predictive control, first-principal models, neural networks, and multivariate statistical process control.

The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.

Growth in the global pharmaceutical market is expected to slow in 2007, based on the industry's increasing reliance on niche and specialty products and greater generic drug penetration, according to a forecast by IMS Health. Generic drugs, along with biotechnology and specialist-initiated products, are expected to outperform the overall market in 2007. Despite slower growth in the United States and Europe, growth in emerging countries, including China, is projected in the double digits.

SAFC Pharma has been appointed by BTG to provide chemical development services relating to BGC20-1259, a potential treatment for Alzheimer?s disease.

Cambrex Corp. signed a definitive stock-purchase agreement to sell two of its human-health facilities to a holding company controlled by International Chemical Investors II S.A. (Frankfurt, Germany).

Indianapolis, IN (Oct. 17)-Eli Lilly and Company agreed to acquire ICOS Corporation (Bothell, WA) for $2.1 billion.

Washington, DC (Oct. 13)-In a four-year study of pharmaceutical manufacturing, two business scholars found that initiative and information correlate with high productivity.