NextPharma sterile product development centre in Belgium receives AFMPS approval

Published: 30-Nov--0001

European contract manufacturer NextPharma has received approval from the AFMPS (Belgian Regulatory Authority) for its new Sterile Product Development Centre (SPDC) in Braine l’Alleud, Belgium.

The SPDC, opened 12 months ago, is geared towards high-quality development-scale sterile clinical trials manufacture. It supports pharma projects from pre-formulation and formulation development through to clinical development and manufacturing with lyophilisation for Phase I to Phase III clinical trials and scale-up capability to commercial scale.

“We will immediately commence GMP manufacture for existing customers and finalise preparations for those new customers with whom we are in late stage discussions requiring manufacture of their Investigational Medicinal Product in 2009,” said Sean Marett, md of NextPharma Technologies’ product development services.

The SPDC has segregated clinical trials manufacturing suites allowing development of high potent products to Occupational Exposure Limits (OEL) 4, as well as conventional and biologics injectables including solutions (water and solvent based), emulsions and lyophilised formulations. The centre provides products in glass and plastic vials and pre-filled syringes.

All clinical materials are manufactured in accordance with cGMP requirements of US FDA, EMEA and other regulatory agencies.

The facility’s analytical laboratories provide biological and small molecules drug testing, analytical development, lyophilisation cycle development and validation services.

NextPharma, headquartered in Send, Surrey, UK, has expertise in cytotoxic production with the ability to manufacture batch sizes for early phase clinical programmes from a few hundred to 110,000 vials of product for a Phase III clinical programme.

Contact T +44 1483 479 120 www.nextpharma.com

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