NextPharma Technologies Receives Positive Initial Inspection from the AFMPS at its Sterile Product Development Center in Belgium

Surrey, UK, 23rd July 2009

Surrey, UK, 23rd July, 2009 - NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotech industry, is pleased to announce that it has received a positive initial inspection from the AFMPS (Belgian Medicines Agency)  at its Sterile Product Development Center (SPDC) in Braine l’Alleud, near Brussels in Belgium.

Sean Marett, Managing Director, NextPharma Technologies, Product Development Services commented: ‘The SPDC is a state of the art facility geared towards the needs of companies around the world requiring high-quality development-scale sterile clinical trials manufacture including full lyophilization capabilities. The new facility is designed to provide customers with a more efficient and faster option to develop and manufacture their products for clinical trials. I’d like to commend the SPDC team and the Quality specialists who have contributed to this achievement, we are pleased to have received this positive result and look forward to completion in August”.
 
The SPDC supports customers' pharma development projects from pre-formulation and formulation development through to clinical development and manufacturing with lyophilization for Phase I and Phase III clinical trials with scale-up capability in our Braine l'Alleud manufacturing facilities, in accordance with the highest regulatory requirements. The facility is staffed by scientists and experts in manufacturing and lyophilization cycle optimization who have over forty years collective experience in steriles manufacturing and lyophilization development.

The SPDC has segregated clinical trials manufacturing suites allowing development of high potent products (OEL4) as well as conventional and biologics injectables including solutions (water and solvent based), emulsions and lyophilized formulations. The SPDC has the capability to provide products filled into vials (glass and PE) and pre-filled syringes.

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

The facility's analytical laboratories provide a full range of biological and small molecules drug testing, analytical development, lyophilization cycle development and validation services. Stability programs are conducted according to ICH guidelines.
 
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 any new product entering the SPDC is performed prior to the start of pharmaceutical formulation development and clinical trials manufacturing.

We are able to manufacture batch sizes for early Phase clinical programme of a few hundred to 6,000 rising to 110,000 vials of cytotoxic product for a Phase III clinical programme in our commercial facility.
 
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers from tablets and capsules to antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing, with particular expertise in pharmaceutical development and manufacture of oncology medicines.