Cambrex sets up a center of excellence for API clinical supply

| By | API, Cambrex, Pharmaceutical Manufacturing

Cambrex Corporation, the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), and finished dosage forms announced that it is to establish a center of excellence for API clinical supply and process development at its site in High Point, North Carolina (USA).

Cambrex will acquire its currently leased facility, as well as an adjacent building which will be fitted out with kilo-scale and pilot-scale vessels, continuous reaction production, and chemistry, engineering and analytical development laboratories. The purchase of the current and adjacent facility is in response to growing customer requirements for clinical supply manufacturing, analytical and chemical development. The center will also focus on the development of new technologies, innovative chemistry and engineering solutions as well as expertise in technology transfer to commercial scale.

At its High Point facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg in support of clinical trials from Phase I through 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.

In April 2017, Cambrex announced that it had completed the construction and validation of a new $3.2 million analytical laboratory at the High Point facility to support growing customer demand for analytical development and validation services in support of clinical stage cGMP products.

Founded in 1981 and headquartered in East Rutherford, New Jersey (USA), 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 dose 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.

SOURCE: cambrex
GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.