NextPharma starts GMP production at Belgian facility
pharmafile | November 11, 2009 | News story | Manufacturing and Production |Â Â Next PharmaÂ
UK-based contract manufacturer NextPharma Technologies has been given the green light from Belgium’s regulatory agency, the AFMPS, for its recently opened Sterile Product Development Centre (SPDC) in Braine l’Alleud.
Nextpharma will “immediately commence GMP manufacture for existing customers” at the plant said the company’s managing director Sean Marrett. The company signed its first contract for the facility in April.
The SPDC opened 12 months ago and is a development-scale manufacturing unit for sterile products, specialising in supplying volumes of product for testing in clinical trials. Preliminary approval was granted by the AFMPS in July.
The SPDC offers formulation, development (including lyophilisation cycle optimisation), methods development and stability testing of sterile products and manufacturing of clinical trials material.
It is able to manufacture batch sizes from just a few hundred vials for early-phase studies, up to more than 100,000 vials for a phase III clinical programme, and can also be used to make high-potency active pharmaceutical ingredients (HPAPIs) such as cytotoxics, thanks to a segregated and contained production line.
“The new facility is designed to provide customers with a more efficient and faster option to develop and manufacture their products for clinical trials,” said the firm in a statement.
The unit will also provide packaging and distribution services, and has the advantage of close proximity with a vial-filling unit operated by NextPharma partner Aseptic Technologies near Brussels.
Last year, the two companies signed a deal in which NextPharma subcontracts the filling of vials to Aseptic, which uses a novel ‘closed vial’ technology using pre-sterilised vials that eliminates the need for washing, dehydrogenation and sterilisation processes and improves sterility assurance.
Meanwhile, the latest approval tops off a busy period for NextPharma, which has also seen the firm expand its logistics and storage services for clinical trial sponsors, via the expansion of its facility in San Diego, USA last month and the opening of a dedicated facility in Gottingen, Germany, towards the end of 2008.
The UK firm also forged an alliance last month with Carbogen Amcis, a subsidiary of India’s Dishman, in which it provides investigational medicinal product (IMP) development services and early-stage manufacturing, particularly for HPAPIs, with Carbogen Amcis handling later-stage development, manufacturing and commercialisation work.
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