On May 15, 2018, Cambrex reported that it had completed a pilot plant expansion at its High Point, NC facility with the installation and commissioning of a fourth reactor suite. The new 400-sq.-ft. suite includes two 2000 L glass-lined reactors and a Hastelloy C22 filter dryer, allowing the manufacture of batch sizes ranging from 10–100kg under cGMP conditions for clinical-phase projects. The installation increased the site’s reactor capacity by approximately 30%, according to a company press release.
The company noted that it also upgraded its analytical chromatography data systems for quality control and analytical R&D to Empower 3 software (Waters).
In April 2018, the company announced it completed installation of multiple continuous flow reactor platforms at the High Point facility; the platforms will focus on the rapid development of processes to supply clinical and commercial demand for chemical syntheses.
The company also completed the construction and validation of a $3.2-million, 11,000-sq.-ft. analytical laboratory at the High Point facility to meet customer demand for analytical development and validation services in support of clinical stage cGMP products. More than 20 analytical instruments, including high-performance liquid chromatography (HPLC), mass spectrometers, and support equipment were added, and 12 analytical scientists will be hired, the company reports.
The company also reported on May 15 progress in construction for a $24-million facility at the company’s Charles City, IA plant, for the manufacture of highly potent APIs. A 4500-sq.-ft. production area, which will have a reactor capacity of 2200 gallons and will manufacture batches from 50–300kg, will operate to an occupational exposure limit down to 0.1µg/m³.
The existing small-scale manufacturing area will be reconfigured, providing a single high-containment building to support early stage development and manufacturing. The facility is expected to be operational in the first half of 2019, the company reports.
Source: Cambrex Corporation