Surrey, UK, 2nd February, 2011 - NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is pleased to announce that it has entered into partnership for technological innovation with Bone Therapeutics, a bone cell therapy company based in Belgium, Université Libre de Bruxelles (ULB) and Université de Liège (ULg).
The partnership is being overseen by BioWin, the Health Cluster of Wallonia, in Belgium. The collaboration involves the development of Bone Therapeutics products to advance therapeutic approaches for the treatment of inflammatory mono-arthritis combining “novel” anti inflammatory compounds and viscoelastic scaffolds.
The first product to be developed will be a sterile depot (sustained release) formulation in pre-filled syringes for intra-articular administration. Product development and manufacture of this sterile investigational medicinal product in pre-filled syringes will be undertaken in NextPharma’s new state-of-the-art Sterile Product Development Center in Belgium and laboratory work has already begun.
Successful clinical trials will result in the product’s commercial manufacture at NextPharma’s commercial scale sterile manufacturing facility on the same site. The site has recently been successfully FDA and PDMA (US and Japanese regulatory authorities) inspected and has extensive know-how in the production of lyophilized and non-lyophilized sterile pharmaceutical products, gained through over twenty years of experience in formulation development, manufacturing and packaging of sterile cytotoxic and non-cytotoxic products.
Sean Marett, Managing Director, NextPharma Technologies, Product Development Services (PDS) commented: “We are very pleased to be a part of this important project and to work alongside Bone Therapeutics, ULB and ULg. This work provides NextPharma with a great opportunity to demonstrate our investigational medicinal product development and manufacturing skills in pre-filled syringes as well as our ability to seamlessly scale-up from clinical trials to commercial scale quantities of the product at our Braine-l’Alleud site in Belgium in due course”.
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 (lyophilized and liquid fill), with particular expertise in product development and manufacture of oncology medicines.
NextPharma has recently been acquired by Sun European Partners with a view to leveraging NextPharma’s strong track record, reputation and state of the art facilities, to grow the business both organically and by acquisition.
Chief Executive Officer
NextPharma Technologies Holding Limited
Tel +44 (0) 1483 479 121
About NextPharma’s Sterile Product Development Center
The Sterile Product Development Center supports customers' pharmaceutical development projects from pre-formulation and formulation development through to investigational medicinal product manufacturing with lyophilization 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 Sterile Product Development Center 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 lyophilized 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, lyophilization cycle development and validation services. Stability programs 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 Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry.
We offer a full range of services from early phase product development, through clinical trial packaging (Phases I through III) to high volume commercial manufacturing. We are a world leader in lyophilization, sterile fill finish and pellet technologies and in specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins and controlled drugs. Our sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules. Additionally we have significant expertise in paediatric drug formulation, development and manufacture. NextPharma offers ‘one-stop’ logistics solutions tailored to meet the needs of the global pharmaceutical industry under the rigid standards of cGSP/GDP regulations.
We operate globally with seven product development centres, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan.
We have 1,200 employees dedicated to serving over 200 customers world wide and a customer base, which includes many of the world’s leading pharmaceutical, specialty pharma and biotech companies.
We have a proven track record in almost all pharmaceutical technologies and product forms and in addition to the specialist areas above have capabilities in solids, semi-solids, liquids, sprays and dry dosage form technologies.
All of our sites are either FDA inspected, in the process of upgrade for inspection or targeted for upgrade for inspection.
About Bone Therapeutics
Headquartered at the Biopôle of Gosselies (South of Brussels, Belgium), Bone Therapeutics is a leading International biotechnology company specialized in the treatment of osteo-articular diseases using cell therapy. With its proprietary cell technology platform, the Company is developing innovative cell products for the repair and regeneration of bone and joint tissues.
The Company’s leading competitive position in skeletal tissue reparation is supported by an outstanding knowledge of the bone physiology and pathophysiology, the pioneering works of its founders in stem cell transplantation in humans and a long-standing expertise in cell therapy clinical trials and regulatory affairs.
BioWin is the Health Competitiveness group of Wallonia, a region south of Brussels in Belgium. It was established in July 2006 and its role is to bring together all companies, academics, opinion leaders and other scientists from the Walloon Region who are involved with and invest in innovative projects or education in the fields of biotechnology and health. BioWin’s role includes selecting projects, monitoring progress and to providing specific analysis on the commercial potential of the projects.