Informex Roundup

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-02-08-2008, Volume 4, Issue 2

Contract manufacturers of active pharmaceutical ingredients and intermediates unveil expansion plans and strategies at this year's Informex.

Contract manufacturers of active pharmaceutical ingredients (APIs) and intermediates and technology providers were fairly optimistic at this year's Informex, held Jan. 29–Feb. 1 in New Orleans. Suppliers report good business conditions, particularly in the outsourcing activity among emerging pharmaceutical companies. Several companies took the opportunity to unveil or further discuss expansion plans and strategy.

Lonza reports strong growth

A positive sign for the contract manufacturing market is the recent financial performance of industry leader Lonza (Basel, Switzerland) in its exclusive synthesis and biopharmaceutical business. Lonza reported a sales increase of 29.4% in its exclusive synthesis and biopharmaceutical business to CHF 1.39 billion ($1.27 billion) in 2007. Sales in its biopharmaceutical business grew 68% to CHF 788 million ($725 million) in 2007. Its capacity utilization was over 90% throughout 2007, and the company has a pipeline of more than 135 projects for its microbial and mammalian services.

Another favorable event for Lonza in its biopharmaceutical business was the signing of a long-term agreement with Sanofi Pasteur (Lyon, France) for cell-culture production. Under the agreement, which was announced in late January, Lonza will provide Sanofi Pasteur with its expertise in mammalian cell-culture operations.

Lonza reported improved results from its exclusive synthesis business although the business performed below expectations. Lonza's exclusive synthesis business had sales of CHF 600 million ($552 million) in 2007 and capacity utilization of more than 90%. Constraints from the high level of capacity and changes in its product mix, however, limited sales growth for 2007, according to the company. Lonza reported that its turnaround project at its small-molecule plant in Riverside, Pennsylvania, showed promising results and that it ramped up production at its peptide facility in Braine-l'Alleud, Belgium.

To help drive future growth, Lonza formed Lonza Innovation for Future Technology (LIFT), an initiative designed to drive innovation in chemistry and biotechnology. The LIFT initiative establishes a full-time team within Lonza to manage and drive innovation projects and will be funded annually in the range of low double-digit CHF millions ($10 million). The focus is on long-term projects, with five to eight years expected between initial ideas and business implementation. Expected peak sales from the projects are expected to follow in 10–12 years.

Expansion plans

Several companies announced expansions at Informex. Shasun Chemicals & Drugs (Chennai, India) is setting up a process-development facility in Piscataway, New Jersey. The facility will be scaled to provide direct API development for preclinical and clinical-trial materials in North America. The first phase of the new facility will be operational in April 2008, and full capacity is expected to be operational in October 2009.

Saltigo (Langenfeld, Germany) will open a kilo laboratory and pilot plant in Redmond, Washington. The site includes offices, laboratories, and technical facilities formerly used by Icos, a subsidiary of Eli Lilly (Indianapolis, IN). The move provides Saltigo with an operating base in the United States and the ability to provide APIs for early clinical testing up to and including Phase IIa clinical trials under good manufacturing practices (GMPs). Timothy Fitzpatrick, former associate director of Icos, will be the manager of the Redmond site, where up to 25 people will be employed. Work at the new site will begin in stages over the next several months.

Saltigo recently upgraded its production plant in Leverkusen, Germany for EUR 10 million ($14.8 million) to allow for multifunctional production under GMPs for APIs and pharmaceutical intermediates. Total capacity of the new facility is more than 200 metric tons per year.

CiVentiChem (Research Triangle Park, NC) is building a pilot plant at its operations, Indus BioSciences, in Hyderabad, India. Indus currently occupies a 12,000- ft2 building with a staff of 50 chemists involved in contract research and development. The new 50,000-ft2 pilot plant will have equipment ranging from 200 to 2500 L vessels, hydrogenation equipment, high-potency laboratories, GMP suites, and in process quality-control capabilities.

NPIL Pharma (Mumbai, India) commissioned its sixth high-potency substance production suite at its Grangemouth, Scotland, facility. The facility will come on stream during the first quarter of 2008 at an investment of $270,000. The new facility is optimized for GMP manufacture of antibody drug conjugates. The facility will run batch sizes from 500–1000 g and have annual production of up to 50 kg.

The expansion follows a $500,000-investment in 2006 for containment upgrades that added GMP capacity for clinical-trial materials. The Grangemouth facility is part of NPIL Pharma's pharmaceutical development and scale-up services business unit.

NPIL also agreed to acquire Healthline Private (Bangalore, India) for Rs 150 million ($3.8 million). Healthline has an injectable manufacturing unit at Bangalore for small and large volume injectable products. The facility has a capacity of 10 million vials per year on a single-shift basis.

Novasep (Boothwyn, PA) installed and validated a new industrial highly-potent API manufacturing plant in Le Mans, France. The EUR 8-million ($12-million) investment is part of an overall EUR 50-million ($74-million) investment made over time at the Le Mans, facility.

SAFC (St. Louis, Mo.) reported on the second-phase of a $600,000-expansion of its solid-state services Pharmorphix research facility in Cambridge, United Kingdom. The expansion adds 7500 ft2 of laboratory capacity. As part of a multi-phase development program, the additional, fully refitted space is scheduled for completion in the first quarter of 2008 and will augment the current 12,500-ft2 facility. The development includes office reorganization and will facilitate installation later this year of additional spectroscopic and diffraction equipment.

This new expansion follows a recently announced $12-million expansion of SAFC Pharma's viral-product manufacturing facility in Carlsbad, California and the Pharmorphix services launch in the United States at its high-potent manufacturing facility in Madison, Wisconsin with new X-ray powder diffraction analytical equipment. Other recently announced investments include a $10-million expansion of commercial-scale API manufacturing and storage capacity, respectively, at Arklow, Ireland, and Buchs, Switzerland, a $29-million potent-fermentation expansion in Jerusalem, Israel, and a high-potent API conjugation suite at its St Louis, Missouri, manufacturing campus.

Cambrex (East Rutherford, NJ) added to its toolbox with the pending acquisition of ProSyntest AS (Tallinn, Estonia), a privately held R&D company. ProSyntest employs roughly 25 chemists at the Tallinn Technology Park in Tallinn, Estonia and was formed as a spinoff from the Tallinn University of Technology. ProSyntest has expertise in chiral and organometallic chemistries. The company will be integrated into Cambrex Karlskoga, a subsidiary of Cambrex.

In another move in catalysis, Codexis (Redwood City, CA) introduced Codexis "MicroCyp Plate," a research productivity tool for identifying and synthesizing drug metabolites and drug lead candidates. The tool is based on a platform technology for preparing and identifying drug metabolites generated by bacterial cytochrome P450 enzymes licensed by Codexis from the California Institute of Technology. Specifically, the research tool is based on a specific cytochrome, 102A1, which metabolizes fatty acides in the microbe.

Codexis also reported that it opened a research center of excellence in fermentation-strain development and process technology in Budapest. The new facility, Codexis Laboratory Hungary, is Codexis's second facility in Europe.

DSM Pharma Chemicals (Parsippany, NJ) and DSM Anti-Infectives were awarded the Gold DMS Innovation Award for 2007 for the development and scale-up of a recombinant pig liver esterase that was used in the synthesis of a registered starting material for a blood pressure-lowering drug. The team developed the pig liver esterase in four months involving 75 people from DSM sites and a group from the Graz University of Technology.

In other news, DSM Pharmaceuticals and APT Pharmaceuticals APT Pharmaceuticals (Burlingame, CA) signed a manufacturing pact under which DSM will produce the commercial drug supply of a sterile product for pulmonary delivery for APT Pharmaceuticals at DSM's Greenville, North Carolina, facility.

Helsinn (Dublin, Ireland) opened a new small-scale cGMP manufacturing plant at its site in Dublin, Ireland. The new GMP plant can run small scale (0.5–2 kg) operations.

AMRI (Albany, NY) completed its purchase of FineChem Laboratories (Aurangabad, India). The move will allow AMRI to make custom pilot-scale intermediates in India, which is expected to begin in the second quarter of 2008. AMRI had acquired manufacturing facilities in Aurangabad and Navi Mumbai in 2007 and also has chemical process development facilities in Hyderabad.

(Albany, NY)

International Specialty Products is constructing a new 16,000 metric ton plant for producing pharmaceutical-grade tetrahydrofuran (THF) at its manufacturing's site in Marl, Germany. The addition of the new plant will nearly double the company's total pharmaceutical-grade THF capacity, which is now 20,000 metric tons and is produced at Marl. Manufacturing at the new Marl plant is scheduled to begin at the end of 2008. THF is used a reaction and extraction solvent in producing APIs.