Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

In 2007, the global pharmaceutical market is expected to grow moderately while biologics, generic drugs, and specialty-initiated drugs are projected to increase at double-digit rates. These trends for finished pharmaceuticals are reflected in the global market for active pharmaceutical ingredients (APIs), where the merchant generic API market is expected to see strong demand. On a production basis, India and China are forecast to raise their shares of the global generic API market against industry strongholds Italy and Spain. Meanwhile, the United States is expected to hold its its position as the leading producer of biotechnology-based APIs in an area traditionally dominated by captive production. And biogenerics or biosimilars gradually reshape the market.

The Changing Fortunes of APIs

Ali Nokhodchi, PharmD, PhD, is an associate professor of pharmaceutics and visiting professor at King's College, Department of Pharmacy, School of Health and Life Sciences, Franklin-Wilkins Building, 150 Stamford St., London, Englad SE1 8WA.

Water interacts with pharmaceutical solids at virtually all stages of manufacture, from synthesis of raw materials to the storage of the final dosage form. The interactions of water with powders is, therefore, a major factor in the formulation, processing and product performance of solid pharmaceutical dosage forms.

The effect of storage conditions on the physical stability of tablets

The Dow Chemical Company (Midland, MI) has agreed to acquire Wolff Walsrode, a manufacturer of cellulose products and a business unit of the Bayer Group (Leverkusen, Germany, www.bayer.com).

Dow to Buy Wolff Walsrode, Cellulosics Supplier

Basel, Switzerland (Dec. 5)-Lonza Group Ltd. and Singapore?s Bio*One Capital have formed a joint venture, Lonza Biologics Tuas, to build a large-scale mammalian cell-culture facility in Singapore for as much as $350 million.

Lonza Advances Manufacturing Strategy

Brussels, Belgium (Dec. 5)-The debate over biosimilars in Europe was heightened last week between the European Generics Association and the International Alliance of Patients Organizations, a patient advocacy group that issued a briefing paper on biosimilars to the European Parliament, the legislative arm of the European Union (EU).

European Generics Association Responds to IAPO Paper on Biosimilars

Princeton, NJ (Nov. 30)-Rockwood Holdings, Inc. agreed to sell its Group Novasep subsidiary for EUR 425 million ($567 million) to a consortium of buyers consisting of Glide Buyout Partners BV, Banexi Capital, and Group Novasep management.

Novasep Sold for EUR 425 Million

Pharmaceutical companies ally with specialty companies and research organizations to advance biocatalysis.

Biocatalysis Advances in Pharmaceutical Development

Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.

Novartis Plans Additional Data on Manufacturing Issues for Mycograb

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.

Antimicrobial Preservatives in Protein Drugs

AAPS, San Antonio (Oct. 31)-Excipient manufacturers are raising concerns over recently adopted European guidelines, set to become effective January 1, 2007, which provide a framework and approach for dealing with genotoxic impurities in new active substances.

Ingredients