San Diego plant will help clients concentrate on R&D, says Althea
Althea said that the project, which was initiated in early 2007, had been driven by growing industrial demand for outsourced manufacturing capacity, particularly among local drug and biotechnology firms that are more R&D than production focussed.
The firm went on to say that the manufacturing capacity provided at the facility, which meets with US and European production guidelines, will allow its industrial clients to concentrate investment on R&D and other core innovative competencies.
Company CEO Shabbir Anik said that: "The new facility was designed to provide flexible capacity and expand our services from early clinical development through Phase III and commercial supply."
These thoughts were echoed by co-Chairman Magda Marquet who said the 30,000 sq ft facility “allows Althea to take an integrated approach in the manufacturing of exciting new biotechnology derived therapies.”
The new building is the third to be located at the company's San Diego campus, which houses five good manufacturing practice (GMP) production suites, dedicated space for making plasmid DNA, proteins and carrying out lyophilisation, as well as vial and syringe filling for preclinical and clinical products.
The active pharmaceutical ingredient (API) unit of the new plant features a fermentation train leading to 1,000 litre scale batch production and downstream processing facilities.
Facilities for aseptic fill and finish activities include automated vial and syringe filling, inspection and labelling equipment capable of batch sizes of over 100,000 units.
