Certification for high-potency manufacturing
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Lonza
(Basel, Switzerland) is investing CHF 80 million ($68 million) for a new manufacturing site in Visp, Switzerland, for large-scale
production of highly potent APIs. As part of the investment, Lonza plans to hire approximately 40 new employees by 2009.
Lonza is also adding large-scale production of antibody drug conjugates. The manufacture of antibody drug conjugates involves
the coupling of a highly active chemical substance with a biotechnologically manufactured antibody. Lonza is investing in
a new production unit and supporting development and analytical laboratories, all to be located in Visp. Construction of the
commercial-scale plant in Visp began in the last quarter of 2006. Stage I is expected to be on line in 2008. The plant will
initially be capable of producing more than 100 kg of antibody drug conjugates per year, and future expansion plans are built
into the design. Lonza currently operates laboratory-scale production of drug antibody conjugates and is bringing small-scale
pilot facilities on stream in 2007.
Carbogen Amcis
(Bubendorf, Switzerland), which offers manufacturing of highly potent APIs, added new high potency analytical and quality-control
laboratories at is facilities in Bubendorf, Switzerland, earlier this year. The laboratories are designed to support analytics
of highly potent compounds down to an occupational exposure limit of 0.3 μg/m3 .
Cambrex
(East Rutheford, NJ) is adding laboratory space to its high potency site in Charles City, Iowa. The project adds 11,500 ft2 with five new process development and kilo-laboratory production suites for highly potent APIs. The expansion also includes
enhanced facilities for analytical development and quality control. Cambrex expects the expansion to be completed in early
2008.
Aptuit
(Greenwich, CT) gained high-potency manufacturing capabilities with the acquisition of EaglePicher Pharmaceutical Services.
Aptuit completed its purchase of EaglePicher Pharmaceutical Services earlier this year.
NPIL Pharma
(Mumbai, India) also recently expanded its high-potency substance facility in Grangemouth, Scotland. The Grangemouth facility
provides contract manufacturing of cytotoxics and prostaglandins for preclinical and clinical development. The expansion includes
the recruitment of 16 additional technical and operational employees and a roughly $500,000-investment in containment upgrades.
The hardware investment brought more CGMP capacity for clinical trial materials on stream in late 2006. The new containment
upgrades to an existing GMP suite include additional high-integrity barrier isolation for the safe handling for Category IV–V
toxins for conjugation to monoclonal antibodies and targeting agents. NPIL Pharma gained the Grangemouth facility as part
of its acquisition of the custom manufacturer Avecia Pharmaceuticals in December 2005.
Ferro Pfanstiehl Laboratories
(Waukegan, IL) expanded its manufacturing capabilities for highly potent APIs last year. In 2006, the company commissioned
a new Class IV (performance-based exposure control level) containment facility in Waukegan, Illinois. The facility is designed
for low-volume production of highly potent APIs, including small-molecule new chemical entities in early-phase development.
The 2000-ft2 addition offers production of preclinical through commercial quantities ranging from 1–5 kg. The kilo laboratory complements
product batch capacities of 3–50 kg in Ferro Pfanstiehl's existing commercial containment facility in Waukegan.
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