Surrey, UK, 17th September, 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 entered into an agreement with Imperial College London to develop a lyophilized peptide formulation and to manufacture the resulting Investigational Medicinal Product (IMP) for clinical trials. NextPharma will also be performing International Conference on Harmonization (ICH) stability studies to support the clinical product.
Formulation development, lyophilization cycle optimization and GMP manufacture will be undertaken at NextPharma’s Sterile Product Development Centre (SPDC) in Braine l’Alleud near Brussels, Belgium.
Sean Marett, Managing Director, NextPharma Technologies, Product Development Services commented: ‘We are pleased to have the opportunity to work on this important project with Imperial College which allows NextPharma to deploy its full range of sterile service capabilities in its new state-of-the-art facilities in Belgium”.
The SPDC (which has recently received a positive initial inspection from the AFMPS) supports customers’ pharmaceutical and biologics sterile development projects from pre-formulation and formulation development through to clinical manufacturing in either lyophilized or solutions format for Phase I to Phase III clinical trials in accordance with the highest regulatory requirements.
Seamless transfer to NextPharma’s commercial sterile manufacturing unit on the same site in Braine l’Alleud ensures continuity and consistency of manufacturing as customer products move from the clinical phase of testing to market introduction. 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.
The design of the facility to a high level of containment 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.
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 method development and validation, and support for formulation studies, including lyophilization cycle development and validation services. Stability programs are conducted according to ICH guidelines.
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 product development and manufacture of oncology medicines.
Consistently rated amongst the world’s best universities, Imperial College London is a science-based institution with a reputation for excellence in teaching, research and innovation.
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 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 narcotics. Our sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules.
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.
