Cambrex Expands Analytical Capabilities at its High Point, NC Site
12.11.2018
IND submission is a major milestone in the life of your drug. We can provide all supporting analytical data to help ensure a smooth application process.
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We can provide lab-, kilo- and pilot-scale manufacturing for preclinical studies and all phases of clinical trials, supplying milligram to kilogram quantities.
Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. From our sites in Italy, Sweden, and the USA, we are a leading global supplier of generic APIs.
Drug substance tech transfer sounds so simple on the surface, but it’s a complex activity carrying a number of technical, regulatory, and quality risks.
At Snapdragon Chemistry, now part of Cambrex, our chemists specialize in creating custom solutions and technologies to take on your toughest process development and production challenges. This includes expertise in designing and building reactors that enable seamless technology transfer as a process scales up for commercial manufacturing.
At Cambrex, we provide a range of technologies equipped to solve your API manufacturing challenges, and we are flexible enough to handle the most complex molecules.
IND submission is a major milestone in the life of your drug. We can provide all supporting analytical data to help ensure a smooth application process.
You can rely on our extensive portfolio of analytical development solutions and testing services to rapidly advance your molecule for the greatest chance of success.
Cambrex offers a comprehensive suite of testing services for complex biopharmaceuticals including standalone analytical R&D, method validation, release testing, ICH stability, and routine QC testing.
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Cambrex is a leading global supplier of more than 70 generic APIs, as well as intermediates and derivatives.
12.11.2018
East Rutherford, NJ – December 11, 2018 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), and finished dosage forms, today announced that it is investing $1 million at its High Point, NC site to fit out 1,300 sq. ft. of analytical laboratory space and plans to hire 9 chemical research and development scientists, as well as 6 analytical research and development scientists pursuant to this project. This investment follows the new $3.2 million, 11,000 sq. ft. analytical laboratory, completed in April 2018.
The expansion and fit out, which will include the installation of an additional 10 ultra-performance liquid chromatography (UPLC) instruments, is set to be completed by year-end 2018.
“Cambrex is seeing a significant increase in new projects, resulting in increased demand for analytical development capabilities within the Cambrex organization,” commented Brian Swierenga, VP, Operations and Site Director for Cambrex High Point. He added, “This further expansion will not only increase Cambrex’s internal analytical capabilities and capacity, but will assist in getting new products to commercial launch faster.”
At the facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100kg to support clinical trials from Phase I to Phase III. The site is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. The acquisition enhanced Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the US and Europe.
This latest expansion at the 35,000 sq. ft. facility brings the investment at the site to over $9 million since the acquisition of PhamaCore by Cambrex in 2016.
About Cambrex
Cambrex Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics. The Company offers Active Pharmaceutical Ingredients (APIs), finished dosage forms, advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances and continuous processing. For more information, please visit www.cambrex.com