Sterile Product Development Center in Belgium officially opened
NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, recently hosted an inauguration ceremony at its Sterile Product Development Center in Braine-l’Alleud, near Brussels in Belgium.
The ceremony marked the official opening of NextPharma’s Sterile Product Development Center – a facility specifically designed to meet the growing demand for formulation development and production of sterile investigational medicinal products. The inauguration was attended by Laurette Onkelinx, the Federal Deputy Prime Minister, Minister of Social Affairs and Public Health for Belgium; leading scientist Véronique Préat, Professor and Head of the Unit of Pharmaceutics at the Louvain Drug Research Institute of the Université catholique de Louvain in Belgium; as well as local Braine-l’Alleud dignitaries and many of NextPharma’s associates and customers.
Bill Wedlake, chief executive officer of NextPharma commented: 'We are proud to mark the official opening of the Sterile Product Development Center and would like to thank our customers, financial backers, in particular the Royal Bank of Scotland, Fortis and BioWin, but most of all our employees for their support in our realisation of this very important NextPharma strategic facility.
'The initiative to build the centre came about as a result of our transformation of our Belgian facility into a centre of excellence for sterile manufacturing, which led to our investment in this state of the art facility geared towards the needs of companies globally requiring high-quality, development-scale sterile investigational medicinal product manufacture including full lyophilisation capabilities.
'This investment, together with our recently announced investment in the upgrade of our commercial sterile vial area for manufacture of conventional sterile products to commercial scale and our successful FDA inspection to manufacture an oncology product in commercial quantities will enable us to support not only cytotoxic but non cytotoxic medicinal products from development through to commercialization.'
Sean Marett, managing director product development services, added: 'This is a day of celebration for everyone who has contributed towards the building of this great facility and also for the scientists and experts in manufacturing and lyophilisation cycle optimisation who between them have more than 40 years of collective experience in sterile manufacturing and lyophilisation product development.
'We have already successfully undertaken 10 development projects in the SPDC, and we have a strongly growing order book that reflects our ability to provide a more efficient and faster option through the Sterile Product Development Center to develop, manufacture, label, store and distribute our customers’ investigational medicinal products globally.
'The Sterile Product Development Center supports customers' pharmaceutical development projects from pre-formulation and formulation development through to investigational medicinal product manufacturing with lyophilisation for Phase I to Phase II clinical trials with scale-up capability to Phase III and commercial scale in our commercial manufacturing facility on the same site, in accordance with the highest regulatory requirements.'
The SPDC has segregated investigational medicinal product manufacturing suites allowing manufacturing of cytotoxics and separately high potency (to OEL4) or conventional products in water- or solvent-based solutions, emulsions and lyophilised formulations. The Sterile Product Development Center has the capability to provide products filled into glass and plastic vials and pre-filled syringes.
All clinical materials are manufactured and supplied in accordance with cGMP requirements of FDA, EMEA and other regulatory agencies.
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 Harmonization (ICH) guidelines.
The site can manufacture investigational medicinal products for early phase clinical programmes of a few hundred vials rising to 110,000 vials of product for a Phase III clinical programme.
NextPharma develops, manufactures, packages and distributes a broad range of products and formulations for its customers, including solids, liquids and semi-solid dosage forms, antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing (lyophilised and liquid fill), with particular expertise in product development and manufacture of oncology medicines.