NextPharma’s Sterile Product Development Centre in Belgium offers safe handling of HPAPIs
NextPharma, a European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is successfully manufacturing GMP batches of product for clinical trials at its Sterile Product Development Centre in Braine-l’Alleud, near Brussels in Belgium.
The facility has been designed to a high level of containment, which together with stringent training and strict waste management procedures allows the safe handling of highly potent compounds to OEL 30ng/m³. A risk assessment of all new products entering the Sterile Product Development Centre is performed prior to the start of pharmaceutical formulation development and clinical trials manufacturing. Sean Marett, managing director of NextPharma Technologies, Product Development Services, said: “The ability to formulate and manufacture this challenging product was through a combination of the sterile product development team’s significant experience in lyophilisation techniques combined with utilisation of cutting-edge technologies afforded by our new Sterile Product Development Centre; this is a very pleasing result.” The facility's analytical laboratories provide a full range of biological and small molecules drug testing, analytical development, lyophilisation cycle development and validation services. Stability programmes are conducted according to International Conference on Harmonisation (ICH) guidelines.
The Braine-l'Alleud site 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.
The Centre fills glass and plastic vials and pre-filled syringes with product.
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