Customer Newsletter
Issue 3/09
Welcome to the NextPharma CPHI Japan Newsletter
We look forward to meeting you at the Tokyo Big Sight Exhibition Center from 21st-23rd April, 2009 at our Booth J-23
Find out more about our Sterile Product Development Center (SPDC) at our Japanese ministry accredited site in Braine-l’Alleud, Belgium, which can formulate and manufacture Phase I and II quantities of peptide vaccines, monoclonal antibodies and other aseptic filled products manufacturing up to OEL 4. This facility encompasses two GMP state-of-the-art clinical trial manufacturing suites.
The SPDC’s sterile formulation development and analytics area has the capability to handle pre formulation, formulation development, analytical development and pre-clinical batch supplies. It has an established history of expertise in lyophilization and solution development and can develop drug products based on biologicals as well as small molecules including high potent drug forms such as cytotoxics, cytostatics and high potent hormones, in vials, pre-filled syringes and cartridges.
The SPDC team is highly qualified and has considerable experience in lyophilization, aseptic fill finish and analytical development across conventional, sterile and biological products. In this highly specialized area our team handles aqueous solutions, solutions based on solvent, suspensions, nanoparticles and long-acting formulations.
We are also pleased to announce we have entered into a partnership agreement with Aseptic Technologies to manufacture sterile products using a new ‘closed vial’ technology. Under this agreement we can sub-contract the filling of vials to Aseptic Technologies (at their site near to Brussels) for those our customers wishing to access this new technology – which involves the aseptic filling of vials, based on a completely closed system and using pre-sterilised plastic vials.
NextPharma has invested €9m in the SPDC which is now one of the finest development facilities in the world, which alongside the extensive knowledge of the SPDC team is able to work with our customers in Japan, North America and Europe in their development of new chemical and biological molecules.
To find out more about how NextPharma can service all of your outsourcing needs please contact us on the numbers below.
Sean Marett
Managing Director
Product Development Services
The SPDC facility has been designed in order to ensure that it:
- will operate in dedicated technical and GMP, cytotoxic and non-cytotoxic (bio and conventional) sterile suites, providing product development, clinical trials manufacture, labeling, packaging and distribution, as well as scale-up services.
- provide a seamless transfer to our sterile commercial manufacturing lines through close co-operation with our commercial production team.
- has dedicated project managers assigned to every customer to ensure 'on time in full' delivery according to customer requirements.
- can provide regulatory assistance in writing the CMC section of a regulatory product filing.
In addition to the services offered by the SPDC, our FDA inspected steriles facility in San Diego, California can provide aseptic and non-aseptic bulk formulation, filtration, filling and lyophilization services plus packaging, labelling, validation, documentation services and controlled product storage. Bioserv is FDA inspected for drugs and medical devices and ISO 13485:2003 certified for medical devices.
We welcome the opportunity to meet with you and discuss at CPhI Japan all your sterile products development needs.