EAST RUTHERFORD, NJ – Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, today announced that it had completed the construction of a $24 million highly potent API (HPAPI) manufacturing facility at its site in Charles City, IA. The 6,000 sq. ft. facility is currently undergoing validation and will be ready to commence customer projects in May 2019.
The production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m3 and contain 4 reactors ranging from 200 to 1,000 gallon capacity enabling manufacturing campaigns of batch sizes up to 300 kg. With the completion of this new facility, the Charles City site now has the flexibility to support all phases of development and offer all scales of HPAPI manufacture across the full OEL band spectrum.
“Across our sites, Cambrex has a strong reputation in the handling and supply of potent molecules, and this investment allows us to increase the capacity we can offer our customers,” commented John Andrews, VP, Operations & Site Director, Cambrex Charles City. “We have seen an increased number of molecules in the clinical pipeline being designated as potent and highly potent, so having the flexibility within our manufacturing network to scale up with existing customers as projects progress, as well as accommodate new projects, is crucial to meet those market needs.”
Cambrex’s Charles City, Iowa facility employs over 370 people and is located on a 45-acre site. The site is part of the company’s Drug Substance business unit and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.
Cambrex is the leading small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,000 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist drug substance technologies and capabilities including biocatalysis, continuous flow, controlled substances, solid state science, material characterization and highly potent APIs. In addition, Cambrex can support conventional dosage forms including oral solids, semi-solids and liquids and has the expertise to manufacture specialist dosage forms such as modified-release, fixed dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.