Sterile development and manufacturing facility
UK-based contract manufacturer NextPharma’s plant in Braine-l’Alleud, Belgium specialises in the production and packaging of cytostatic products such as ampoules. The plant produces cytostatic products in small batches for early clinical studies and up to 110,000 vials for Phase III clinical studies. The facility can be scaled up for complete commercial production.
In March 2010, NextPharma announced an investment of €2.4m to expand the facility to produce non-cytostatic products. The expansion will add a sterile vial area (SVA) to the facility.
In September 2010, the site was accredited by the Japanese Pharmaceuticals and Medical Devices Agency. The accreditation was received as a result of a new product launch that required the pre-approval inspection of the cytotoxic production area.
NextPharma SVA facility
The Braine-l’Alleud facility was officially opened in October 2008. The 20,000m² facility is built in 55,000m² site.
The site houses the main facility, a 1,400m² sterile product development centre (SPDC), a GMP production area (7,094m²), and quality control (QC) and microbiology laboratories (550m²).
Other facilities include a warehouse (6,400m²), a warehouse and dispatch area (3,200m²) and an
administration building (1,050m²).
In November 2009, the SPDC became fully operational following approval by the Belgian regulatory agency AFMPS. The approval enabled NextPharma to commence good manufacturing practice (GMP) at the plant.
In March 2010, NextPharma completed an FDA inspection at the SPDC to assess the plant’s compliance with the FDA’s GMP Six Systems. The inspection was in response to a new patented lyophilised medicinal drug, which is planned to be produced at the facility.
Non-cytostatic manufacturing facility expansion
Expansion of the Belgian facility will provide the capability to produce solution and lyophilised vials. The SVA is expected to be operational towards the end of 2010. The expansion will transform the facility into an integrated full service facility catering to a wide range of customers.
NextPharma’s expansion plan is in line with several investments made by the company. It has already expanded the logistics and storage services at its San Diego facility. The company also opened a new facility in Gottingen, Germany.
Belgium facility production
The SPDC at the Belgium facility contains analytical and microbiology laboratories for lyophilisation development and testing of trial drugs. It is designed to a great degree of containment and fills the products in glass and plastic vials and pre-filled syringes. NextPharma is planning to develop new capabilities for the facility to produce new dosage forms.
The microbiology laboratory conducts Limulus amebocyte lysate testing and identifies micro organisms. It is equipped with a dedicated HVAC system and environmental monitoring. The laboratories are equipped with high-pressure liquid chromatography and gas chromatography systems. A UV SR spectrophotometer is also available. The labs carry out sub-visible particulates testing and validation and stability tests.
Rigorous training and waste management procedures are followed at the SPDC to enable the handling of compounds to OEL 30ng/m³. Risk assessment of every new drug arriving at the SPDC is carried out before any work is undertaken by the facility.
Sterile cytotoxic manufacture
For producing sterile cytotoxics, the facility has a separate production and QC area. The area houses one Farmomac F57 filling machine, six freeze dryers, one capping machine, one external decontamination machine and a washing tunnel for depyrogenisation. It also contains a labelling and packaging line. The facility produces sterile cytotoxics in 3ml-100ml vials with filling volume ranging between 1ml and 100ml.
The facility has a dedicated area for producing sterile injectables. The area contains a washing tunnel for depyrogenisation, one IMA F400F filling machine, one freeze dryer and an IMA ALU 400 capping machine. Sterile injectables are produced in 1ml-100ml vials with a filling volume of 1ml to 100ml.
For producing ampoules, the facility is equipped with one Bausch & Stroebel filling machine AFV6010. The ampoules area carries out aseptic filling with automatic visual inspection capabilities. It also labels and packages the product. Ampoules solutions are produced in 1ml-25ml capacities.
A dedicated area is available for producing sterile eye drops. The equipment for this area includes a Farmomac filling machine, and a labelling and packaging line. Sterile eye drops are produced in 2ml to 50ml plastic bottles.
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