27 October 2003 00:00 [Source: ICB Americas]Although much of the recent news from the fine chemicals and custom manufacturing mar-ket has underscored the problems of overcapacity, lower drug output and overall difficult financial conditions in the sector, companies continue to make select investments to build their product and service portfolios. Below is a snapshot of some recent developments from several exhibitors at this year's CPhI Worlwide in Frankfurt.
ALBANY MOLECULAR Re-search Inc.'s subsidiary Organichem opened a new employee center in August. In addition to the new em-ployee center, major capital improvements at Organichem include a new manufacturing facility with four suites designed for producing highly potent pharmaceutical active ingredients such as anticancer compounds as well as several expansions of mid-range manufacturing capacity.
AVANTIUM Technologies BV, a company specializing in high-throughput screening for catalyst development, has launched a technology for the rapid optimization of product purification. The technology, Avantium's Crystal-lization Screening System (CRYSS), is offered as a contract research service to the pharmaceutical, biotech and fine-chemical industry. Earlier this year, Avantium formed a new business unit, Avantium Life Sciences, which merged its Avantium Pharma and Crystallics business units into a single entity.
BASF is launching a new, patent-pending process called Basil (Bipha-sic Acid Scavenging utilizing Ionic Liquids). It is a separation process that uses ionic liquids to remove an acid from a reaction mixture by a simple liquid-liquid phase separation process. Basil's first commercial application is in the manufacture of alkoxyphenylphosphines. BASF plans to apply the principle in other processes and market the system to external customers.
BASF also recently expanded its inorganics portfolio through its $65 million acquisition of certain assets of Callery Chemical, a producer of boron and potassium chemicals used in pharmaceutical products and other applications. BASF says Callery Chemical fits into BASF's new business development activities, targeting boron specialties for selective reduction, hydroboration and Suzuki coupling and hydroxylamine and its derivatives, and completes its range of higher alcoholates and other strong bases.
The acquisition includes Cal-lery's Evans City, Pa., site with the land, production facilities, certain business relationships, and inventory. In 2002, Callery Chemical had sales of $30 million.
BAYER CHEMICALS AG is making an official debut as a separate legal entity and subsidiary of Bayer AG under Bayer's recent reorganization. Bayer Chemicals' activities include its fine chemicals business, which offers the production of pharmaceutical intermediates and active pharmaceutical ingredients and process development services. "Our expanded process development services as well as our differentiating technologies will be at the forefront of our presentation at CPhI," says Roger Pettman, global vice president for marketing pharmaceutical chemistry at Bayer Chemicals. "For example, we are planning to expand our capacities for chiral separation and will officially announce the construction of a new production-scale SMB [simulated moving bed] plant."
BOEHRINGER INGEL-HEIM's new biopharmaceutical production plant in Biberach, Germany opened last month. The 225 million investment is one of the largest single investments ever for the company. The new plant, which doubles the company's capacity for biopharmaceuticals production, has twelve 15,000- liter fermenters.
Boehringer Ingelheim operates a second biopharmaceutical production facility in Vienna with production based on micro-organisms. The company is investing 60 million to double its biopharmaceutical production capa-cities at this site to include two 6,000-liter fermenters. The expansion is slated to be completed in 2005.
BORREGAARD Synthesis opened a new research and pilot plant in Sarpsborg, Norway, in January. The cGMP facility, a NOK 40 million ($5.75 million) investment, triples the company's pilot plant capacity. The unit is equipped with six reactors and associated purification equipment, including distillation columns and four filters, one of which is isolated in a separate end room.
CAMBREX's Cambrex Bio Science Baltimore Inc. recently opened a new biopharmaceutical development laboratory and pilot plant in Baltimore, Md. The bioprocessing facility contains multiple 10-liter fermenters for process de- velopment and 100-liter reactors for pre-clinical and pilot scale production of products derived from mammalian, bacterial and yeast-based expression systems. The new facility offers downstream process development labs and pilot facilities that operate multiple chromatography systems for purification protocol development as well as pilot production.
Cambrex is also constructing a new facility to accommodate four cGMP suites dedicated to cell therapy manufacturing. The expansion will increase the company's manufacturing capacity by 100 percent. The facility and the first two suites are expected to be completed and validated by December 2003. Cambrex, which launched its cell therapy services in early 2001, had earlier signed a term sheet with Ortec International for the commercial manufacture of its tissue-engineered product, OrCel.
Cambrex Corp. recently entered into a business alliance agreement and took a minority equity investment in Analytical Bio-Chemistry Laborator-ies Inc., a Columbia, Mo.-based pro- vider of advanced development and analytical services such as radiolabeled drug candidates for binding studies, ADMET studies, and bioequivalency, stability and other testing services required for FDA drug registration.
CODEXIS, a provider of biocatalysis and fermentation processes and products to the life science and fine chemical industries, opened a new office in Malvern, Pa., in June. The company, a subsidiary of Maxy-gen Inc., recently formed an agreement with Cargill inc. to develop a biological platform for producing specialty chemicals, polymers and other industrial chemicals using agricultural raw materials. Building on metabolic pathways developed by Cargill, Codexis will use its proprietary technologies to enhance the production of 3-hydroxypropionic acid (3-hp) from carbohydrate raw materials. 3-hp has the potential to be a key building block in producing several chemicals and polymers, including 1,3-propanediol, malonates, specialty polyesters and acrylic acid.
DOWPHARMA, a business unit of Dow Chemical Company, launched earlier this year new capabilities in catalytic asymmetric hydroformylation (AHF) of olefins. AHF is a technology that combines the creation of a chiral center with the introduction of aldehyde functionality. Dowpharma has undertaken a research program in catalytic asymmetric hydroformylation since early 2002 by building on the AHF technology platform developed in the early 1990s by Union Carbide Corp, which Dow acquired in 2001.
DR. REDDY LABORATORIES has received received "acceptable letters" from the Food and Drug Administration for two of its bulk actives facilities based at Hyderabad, India. The FDA inspection covered a total of three bulk active products: omeprazole, tizanidine and keterolac tromethamine. Dr. Reddy's has a total of six bulk actives manufacturing facilities.
LONZA Group has entered into a long-term supply agreement with Celltech Group PLC under which Lonza Biotec will manufacture PEGylated antibody fragment-based drugs for Celltech at its production facility for microbial biopharmaceuticals. Celltech has reserved at Lonza Biotec a fixed annual manufacturing capacity in its 1,000-liter and 15,000-liter fermenter systems for recombinant microbial products, covering the period 2004 to 2010, at pre-agreed rates. Lonza Biotec will provide technology transfer, scale-up, cGMP manufacturing and quality control testing services at its site in Visp, Switzerland.
Also, Lonza Biologics and Vac-cinex Inc. formed a strategic alliance earlier this year that offers their res-pective clients a broad range of antibody discovery and manufacturing services. Lonza also brought on a new small scale plant its Visp, Switzerland, this past summer.
KYOWA HAKKO KOGYO Co. Ltd. established a new business earlier this year for developing and commercializing biological technologies and businesses, particularly those relating to monoclonal antibodies. The new business BioWa, based in Princeton, N.J., is a wholly owned subsidiary of Kyowa America Inc., a US holding company of Kyowa Hakko. BioWa is centering on its proprietary Potelligent technology and is seeking strategic alliances with US companies that possess high potential antibody technologies and/or are presently developing antibody medicines. The Potelligent technology is based on methods for enhancing antibody-dependent cellular cytotoxicity (ADCC), a function of the human immune system that uses monocytes and other white blood cells, to destroy cancer cells and other antigens.
PEAKDALE Molecular Ltd. appointed Ryan Scientific Inc. of Isle of Palms, S.C., to act as agents for Peakdale's intermediates and screening compounds in the US and Canada as part of a two-year agreement, effective May 1, 2003. Ryan Scientific will promote and sell Peakdale's range of 465 catalogue intermediates, as well as the company's screening compounds, which currently comprise some 6,600 discrete molecules.
Also, as part of its phased expansion program, Peakdale announced in June that it has fitted out two additional laboratories at its Derbyshire, UK headquarters, which, when taken with the completion of a kilo lab an-nounced in February, has increased its capacity by 60 percent.
ROBINSON BROTHERS Ltd. has formed an industrial and academic consortium, which is close to commercializing a biodegradable poly- mer system for packaging applications. RBL's partners in the R&D project include Aston University, GlaxoSmithKline, process equipment manufacturer ThermoPrism and Euro Packaging.
The company plans to undertake a production run before the end of the year, prior to full-scale commercialization.
ULTRAFINE Ltd. entered into an expanded agreement with Arakis Ltd., whereby Ultrafine will provide early phase cGMP manufacturing. The agreement builds on the companies' current collaboration that uses Ultrafine's medicinal and process chemistry services. Earlier this year, Ultrafine appointed BD Biosciences as exclusive North American distributor for its ADME-Tox chemical products range, including cytochrome P450, UGT substrates, inhibitors and metabolite standards. These compounds are typically used in screening assays to optimize the drug discovery process.
Ultrafine has begun construction of an additional cGMP manufacturing facility to complement its existing suite of three cGMP laboratories, which operate at a 20- to 50-liter scale. The new facility will include 2,000-liter Hastelloy and glass-lined steel reactors, plus a filter dryer for full product containment.
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