NextPharma Technologies Announces Addition of Prefilled Syringe Capabilities at its Sterile Product Development Center in Belgium
Published: Jan 28, 2011
The Sterile Product Development Center will be equipped with semi-automatic syringe fillers with automatic stoppering units under vacuum in both the cytotoxic and non-cyto toxic units of the SPDC. This addition to our already substantial capabilities has been driven by customer demand for formulation development and manufacturing of pre-filled syringes containing both cytotoxic and non cytotoxic products. The new syringe fillers are being configured to fill product aseptically for quantities typically used in Phase I and Phase II clinical trials and the first syringe filler is planned to be in operation in the first quarter of 2011.
Sean Marett, Managing Director, NextPharma Technologies, Product Development Services commented: “Sterile syringe filling is a great addition to our sterile vial filling, sterile bottle filling and lyophilization services and we have already been approached by a number of customers for this service. It not only complements our manufacturing, but also our clinical trials packaging and storage capabilities where we can label and then hold finished product in a temperature controlled environment until our customers request us to ship it directly to clinical trial centers.”
NextPharma PDS operates globally with seven centers of excellence in Europe and North America. PDS services include pre-formulation studies, formulation development, including New Chemical Entities (NCEs), Peptides and New Biological Entities (NBEs), design, development and optimization of lyophilization cycles, manufacturing of investigational medicinal products, analytical and microbiological testing, clinical trial labeling and kitting and stability testing according to ICH guidelines, scale-up services and regulatory support, including product dossier development and registration.
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.
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.
Bill Wedlake Chief Executive Officer NextPharma Technologies Holding Limited Tel +44 (0) 1483 479 121 www.nextpharma.com
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.