Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Degussa AG (D?sseldorf, Germany) and Lynchem Co., Ltd. (Dalian, Liaoning Province, China) signed a contract to establish a custom manufacturing joint venture.

Degussa Forms Fine Chemicals Joint Venture in China

Gilead Sciences, Inc. (Foster City, CA) signed a definitive agreement to acquire the Canadian subsidiary Raylo Chemicals and most of its assets from Degussa AG (D?sseldorf, Germany) for 115.2 million euros ($147 million).

Gilead Sciences to Acquire Degussa subsidiary Raylo Chemicals

CMOs account for 20–30% of biopharm production. Big Pharma also is filling the biologics supply chain. 

A Capacity Wave in Biologics Manufacturing

Arvind K. Bansal is an associate professor at the National Institute of Pharmaceutical Education and Research, Sector-67, Phase-X, S.A.S. Nagar, Punjab 160062, India, tel 191 0 172 2214682 87, fax 191 0 172 2214692.

Bioequivalence with the reference product is the only reliable measure of demonstrating the therapeutic equivalence of a generic product to the innovator product. Systematic and comprehensive innovator product characterization can be used to make generic product development easier. This involves characterization of API and quantification of the critical excipients. The latter contributes towards performance of the final dosage form. This article describes the capsule formulation of a poorly water-soluble drug, celecoxib, which contains sodium lauryl sulphate as a critical excipient. The importance of a decoding process aimed at developing a generic product that matches the innovator formulation in a discriminating dissolution method is demonstrated.

Criticality of functional excipients and decoding methods during generic product development

AstraZeneca PLC (London, England) has agreed to acquire the biopharmaceutical company Cambridge Antibody Technology Group PLC (CAT, Cambridge, England).

AstraZeneca to Buy Cambridge Antibody Technology

Indian suppliers of active pharmaceutical ingredients and dosage formulations expand in India, the United States, and Europe. 

Asian Producers Raise Their Profiles In the Global Pharmaceutical Value Chain

New biocatalytic and chemocatalytic routes to chiral intermediates and developments in simulated-moving-bed and supercritical-fluid chromatography for resolving racemic mixtures. 

Single-Enantiomer Drugs Drive Advances in Asymmetric Synthesis

Pellets are a multiparticle, solid form of medication. The individual pellets are almost spherical with diameters usually between 100 and 2000 ?m.

Sugar spheres: a versatile excipient for oral pellet medications with modified release kinetics

Facing still-sluggish market conditions and a changing world order in fine chemicals, the large Western custom manufacturers are responding by building their toolboxes in specialized technologies in chiral chemistry, catalysis, and biosciences and by adjusting their manufacturing networks via streamlining or investment in Asia. 

Custom Manufacturers Target Chiral Chemistry, Catalysis, and Biosciences

Human plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of therapeutic products have been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring and Octagam from Octapharma.

Ingredients