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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-02-28-2007, Volume 3, Issue 2

A roundup of manufacturing and service expansions for February 2007.

A roundup of manufacturing and service expansions for February 2007.

Greenwich, CT (Feb. 20)Aptuit, Inc. (www.aptuit.com) will invest an additional $100 million in capital projects to expand capacity, improve operating efficiency, and further align its global operations. This announcement follows its completion of two acquisitions, SSCI and EaglePicher Pharmaceutical Services, which added physical chemistry and active pharmaceutical ingredient development and manufacturing to the company's capabilities.

InformexUSA, San Francisco (Feb. 14)NPIL Pharma (Mumbai, India, www.npilpharma.com) unveiled a $100-million investment program in formulation development and manufacturing services. NPIL Pharma has invested roughly $50 million over the past three years as part of its early-phase (development) and late-phase (manufacturing) formulation services in the United Kingdom and India, and plans a similar investment over 2007-2009. The investment includes a new sterile supplies pilot plant, which is scheduled to come on stream in Mumbai, India in the fourth quarter of 2007.

The company's focus on formulation services and final-dosage forms follows the addition of capabilities in this area from NPIL's acquisition of Pfizer, Inc.'s (New York, NY, www.pfizer.com) API and formulation facility at Morpeth, United Kingdom last June. As a result of the Morpeth acquisition, NPIL Pharma now has annualized aggregate drug-formulation capacity of 3 billion tablets, 500 million low RH (< 8%) tablets, 270 million hard-gelatin capsules, 180 million ophthalmic liquids, 48 million glass vials, and 30 million ampules.

The company will launch its integrated formulation capabilities to pharmaceutical customers in Europe and North America beginning in the second quarter 2007.

InformexUSA, San Francisco (Feb. 14)Almac Sciences (Craigavon, Northern Ireland, www.almacgroup.com) plans to collaborate for cytotoxic fill-and-finish services with the Center for Pharmaceutical Science and Technology (CPST) at the University of Kentucky (Lexington, KY, www.uky.edu).


Under an initial agreement, CPST will provide IV formulation and sterile fill of cytotoxics and potents for clinical trial applications. The contract will be delivered through CPST's newly commissioned sterile manufacturing facility at the university's Coldstream Research Campus near Lexington. The $17-million facility opened in May 2006.

This non-exclusive agreement with CPST completes Almac Sciences' supply chain solutions package in cytotoxics and potents, for which it already has in-house process research, development, manufacturing, and logistics capability at its Craigavon, Northern Ireland complex. Almac Sciences manufactures cytotoxic APIs in dedicated facilities.

At InformexUSA, Almac Sciences also announced that its manufacturing site for highly potent compounds in Craigavon earned certification under the "SafeBridge" program, a review and certification program conducted by SafeBridge Consultants, Inc. (Mountain View, CA). SafeBridge conducted a 60-element review of programs, procedures, and containment of the active pharmaceutical ingredient synthesis areas at the site, and based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that Almac meets current industry standards for the safe handling of potent active pharmaceutical ingredients in certain areas of its plants dedicated to handling such materials.

InformexUSA, San Francisco (Feb. 14)Advance Research Chemicals, Inc. (ARC, Tulsa, OK, fluoridearc.com), a manufacturer of fluorine products, is expanding one of its manufacturing facilities in Catoosa, Oklahoma by adding 25,000 ft2 to an existing 85,000-ft2 facility. ARC produces fluorine-based compounds at two manufacturing facilities in Catoosa, one in Mexico, and two in India. The company serves multiple industries, including the pharmaceutical industry.

InformexUSA, San Francisco (Feb. 14)BioCatalytics, Inc. (Pasadena, CA, www.biocatalytics.com) launched a new product line of enzymes for chemical synthesis developed in cooperation with Novozymes A/S (Bagsvaerd, Denmark, www.novozymes.com). The 16 enzymes offered in the product line are the first products to be launched under a cooperative marketing and distribution agreement formed by the companies in late 2006. BioCatalytics has exclusive marketing rights for the new products and formulations for research and development and process development, and Novozymes will be responsible for bulk manufacturing.

BioCatalytics also formed a chiral technology agreement with Almac Sciences (Craigavon, Northern Ireland, www.almacgroup.com) under which the companies will cooperate on an exclusive basis for the development or processes and manufacture of chiral intermediates and APIs.

InformexUSA, San Francisco (Feb. 12)Cambrex Corporation (East Rutherford, NJ, www.cambrex.com) has initiated detailed engineering for an expansion at its Karlskoga, Sweden, site to increase production capacity for small-molecule active pharmaceutical ingredients. The project is scheduled to start in July 2007 for completion by early 2009 and will add a flexible, mid-sized CGMP manufacturing plant. Cambrex Karlskoga currently produces more than 20 commercial pharmaceutical products and completed over 30 clinical phase projects in 2006.

Cambrex also plans to build new laboratory space to augment its existing high-potency facilities in Charles River, Iowa. The project will include the construction of an 11,500-ft2 facility with five new process development and kilo laboratory suites.

InformexUSA, San Francisco (Feb. 14)Codexis, Inc. (Redwood City, CA, www.codexis.com) introduced "Codex" Biocatalysts Panel, a research product designed to facilitate the use of biocatalysis in pharmaceutical manufacture. The product consists of sets of diagnostic enzymes panels that can be used to screen for reactivity in process reactions. The enzymes are optimized for use in pharmaceutical manufacture.

InformexUSA, San Francisco (Feb. 14)—Chemetall GmbH (Frankfurt German, chemetall.com) and Penn Specialty Chemicals, Inc. (Philadelphia, PA, www.pschem.com) formed a strategic marketing agreement for the solvent, 2-methyltetrahydrofuran (MeTHF), MeTHF-soluble organometallic reagents, organic and inorganic salts, hydrides, and alcoxides. MeTHF is a solvent alternative to tetrahydrofuran (THF). Penn Specialty Chemicals commercially produces MeTHF and specializes in producing furfural and furan-based solvents and derivatives. Chemetall is a leading supplier of metal-based chemical applications and lithium-based products. Chemetall has shown that various organogrignard reagents are more soluble in MeTHF than THF and some reactions show improved yields. Chemetall and Penn plan to jointly sponsor scientific events centered around green chemistry and organometallic applications.

InformexUSA, San Francisco (Feb. 14)Excelsyn (Holywell, UK, www.excelsyn.com~) is creating a Synthesis-at-Speed team to operate on a 24/7 basis on kilogram and pilot-plant API development projects. The company also is commissioning a three-phase, $10-million asset upgrade and expansion program for its Holywell, North Wales, facility, with the first phase to be completed during 2007.The second phase of the new investment at Holywell, focused on enhanced cleanroom facilities at 100 kg scale, is planned for completion during 2008.

InformexUSA, San Francisco (Feb. 14)Reaxa Ltd. (Manchester, UK, www.reaxa.com) added "QuadraPure C" to its resin-based metal-catalyst and reagent scavenger range of products that are used to remove impurities in pharmaceutical manufacture. QuadraPure C is a synthetic, porous, high surface-area, nonfunctional carbon-based material used for adsorption of small-molecule organic containments. The product removes color, trace impurities, and odor from active pharmaceutical ingredients, intermediates, and specialty chemicals.

InformexUSA, San Francisco (Feb. 14)SAFC (St. Louis, MO, www.safcglobal.com) completed the initial phase of a two-stage expansion at SAFC Pharmorphix's research facility in Cambridge, United Kingdom. SAFC Pharmorphix specializes in solid-form characterization and research. The company completed a 2,500-ft2 laboratory extension, which will be followed by an additional investment in the spring of 2007 as part of a $600,000 expansion program. SAFC Pharmorphix expects to add additional X-ray crystallography equipment to the laboratory.

InformexUSA, San Francisco (Feb. 14)—Scott Medical Products (Plumsteadville, PA, www.scottgas.com) has chosen the IMCD Group (Mumbai, India) to represent "Selectfluor" and "Deoxo-Fluor" fluorinating reagents in the Indian pharmaceutical market. The products are manufactured by Air Products and Chemicals, Inc. (Allentown, PA, www.airproducts.com/index.asp and are represented by Scott Medical Products, which provides reagents for low-temperature, high-yield, late-stage direct fluorination.