Surrey, UK, 6th April, 2010 - 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 at which Véronique Préat, Professor and Head of the Unit of Pharmaceutics at the Louvain Drug Research Institute of the Université catholique de Louvain, highlighted the growth of and challenges in the pharmaceutical development of biotechnology drugs.
In her presentation Professor Préat noted that biologics comprise 30% of the current compounds in the pharmaceutical industry development pipeline and could well grow to 50% within ten years. To emphasise this growth, Professor Préat compared the global market growth for monoclonal antibodies of 14% per annum with the general pharmaceutical market growth rate of 3 - 6%.
Professor Préat also drew attention to the challenges of formulating biotechnology medicines, particularly formulating and manufacturing proteins which will continue to be delivered through injection requiring sterile manufacturing, although alternative routes such as transdermal and pulmonary delivery continue to be investigated.
At the end of her presentation Professor Préat looked to the future and considered delivery through the use of nanomedicine. This involves the ability to direct pharmaceutical medicines precisely to the site of action, such as the targeted delivery of a cytotoxic pharmaceutical to cancer cells, thereby increasing efficacy and decreasing side effects.
Sean Marett, Managing Director Product Development Services commented: “Professor Préat has highlighted the strong growth of the biotechnology therapeutic market and its challenges in terms of formulation development and sterile manufacturing. We are delighted that NextPharma is ideally placed to respond to this vibrant area of formulation development and manufacture through the deployment of the Sterile Product Development Center’s full range of sterile services capabilities including in formulation development and manufacturing of protein investigational medicinal products as well as cytotoxic products in our state of the art facility in Belgium”.
Bill Wedlake, Chief Executive Officer of NextPharma added “Professor Préat has stressed the growing importance of biotechnology-based therapeutics and NextPharma is strategically positioned to assist our customers develop and manufacture for clinical trials such therapeutics through our timely investment in the Sterile Product Development Center. This capability together with our ability to scale-up and manufacture customers’ sterile products to commercial scale on the same site, together with our successful recent FDA inspection represents a major step towards strengthening our position as the leading European provider of quality contract manufacturing and product development services”.
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 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 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 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.
About NextPharma
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 Professor Préat
Véronique Préat is Professor and Head of the Unit of Pharmaceutics at the Louvain Drug Research Institute of the Université catholique de Louvain. Professor Préat’s research interests are in the area of new drug delivery systems, especially, transdermal drug delivery (electroporation, iontophoresis) and colloïdal drug carriers (polymeric micelles and nanoparticles) on which she has widely published.
