Customer Newsletter
Issue 4/09
Welcome to the NextPharma Bio 2009 Newsletter
We look forward to meeting you at the Bio 2009 International Convention in Atlanta, Georgia from 18th -21st May, 2009 at our Booth 5625
It will be our pleasure to speak with you over the next few days at ‘BIO’!
Our representatives from Europe and the US would like the opportunity to tell you more about our sterile product development and sterile manufacturing capabilities.
Our Sterile Product Development Center (SPDC) in Braine-l’Alleud (near Brussels), has ongoing projects with clients for the formulation development and manufacturing of sterile clinical trials drug products. This work provides evidence of the breadth and depth of our sterile manufacturing capabilities – and also demonstrates how our customers can benefit from an integrated service approach across Europe and the US provided by one company.
Our team at Braine-l’Alleud has one the finest development facilities in the world to support their extensive knowledge base and to work with our customers in their development of new chemical and biological drug products. Additionally, we would like to inform you that the SPDC team has, in close collaboration with our US facility NextPharma-San Diego (Bioserv), executed its first formulation and lyophilization cycle development project of a sterile product for a US based customer.
This achievement marks a very exciting time for NextPharma and the Product Development Services team as we continue to expand our sterile development and sterile manufacturing capabilities.
To find out more about how NextPharma can support all of your outsourcing needs please contact us as detailed 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, NextPharma-San Diego - our FDA inspected steriles’ facility in California can provide aseptic and non-aseptic bulk formulation, filtration, filling and lyophilization services plus packaging, labelling, validation, documentation services and controlled product storage. It has an expanded packaging capacity through the recent installation of an automated labelling line – enabling it to handle larger non-aseptic projects, especially larger packaging jobs. NextPharma-San Diego is FDA inspected for drugs and medical devices and ISO 13485:2003 certified for medical devices.
NextPharma-San Diego has also entered into a non-exclusive outsourcing agreement with Advantar Laboratories Inc. a provider of high quality contract laboratory services to small and mid-sized companies engaged in drug development. Under this agreement NextPharma-San Diego will collaborate with Advantar to provide Advantar’s customers with aseptic and non-aseptic fill and finish services including lyophilization, packaging, labelling, storage and shipment of clinical materials to clinical sites. Advantar will collaborate with NextPharma’s customers based in the United States to provide them with analytical services support including methods development, in process testing and finished product testing of sterile and non-sterile products.



