SPDC Newsletter

Welcome to the SPDC update

NextPharma’s Product Development Services division is pleased to announce that its’ Sterile Product Development Centre (SPDC) in Braine-l’Alleud, Belgium opened officially on 1st October 2008.

Initially, services provided will be formulation development of products to OEL 2/Saftbridge level 2 and from January 2009 to OEL4/Safebridge level 4 (including Cytotoxics). Following on from this, in the second quarter of 2009, we will be providing GMP production of clinical trials material (typically up to 6,000 vials) in support of our existing commercial operations.

We have designed the SPDC to meet the growing demand for formulation development and production of injectable new chemical entities for clinical trials. The SPDC offers formulation, development, including lyophilization cycle optimization, methods development and stability testing of sterile products and manufacturing of clinical trials material in a state-of-the-art, dedicated facility. The facility will operate to FDA, Japanese and EU standards and complements our new clinical trials packaging centre that offers randomisation labelling.

The opening of this unit is a significant milestone in the expansion of our services. 

To find out more about how NextPharma can facilitate your business needs please contact one of our Key Account Managers as detailed below.Kind regards,

Sean Marett
Managing Director
Product Development Services
NextPharma Technologies

The SPDC’s sterile formulation development and analytics area has the capability to handle pre formulation, formulation development, analytical development and preclinical and manufacture of clinical supplies. Our Braine-l’Alleud facility has an established history of excellence in lyophilization and solution development of aseptic products with a renowned expertise in cytotoxics. The SPDC will expand our capabilities to encompass, monoclonal antibodies, proteins, peptides, RNAi, sRNAi and other aseptically filled products including controlled drugs in vials, pre-filled syringes and cartridges as well as preservative-free nasal and eye drops.

The SPDC’s employees are highly qualified, with collectively some forty years of experience in lyophilization and considerable aseptic fill and finish and analytical development expertise. In this highly specialized area, our employees can handle aqueous and solvent based solutions, emulsions, suspensions, nanoparticles and long-acting formulations.

As well as manufacture, we are also able to provide clinical trials packaging services that includes blinding of IMPs, manufacturing of matching placebo,  provision of label design and printing (such as tear-off and booklet labels), developing of packaging design, creation of randomization lists and emergency envelopes, procurement of comparators and batch release by a qualified person into the European Union. We also offer refrigerated, frozen and controlled temperature storage under GMP conditions and distribution of pharmaceuticals and patient kits to clinical trials centres and can provide return, reconciliation and pharmaceutical destruction services.

The SPDC facility has been designed in order to ensure that it:

• will operate in dedicated cytotoxic and non-cytotoxic sterile suites, providing product development, clinical trials manufacture and supply, and scale-up services.

• provides 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 delivery on time to customer requirements every time.

• can provide regulatory assistance in writing the CMC section of a regulatory product filing.

In addition to the services offered by the SPDC in Belgium, we are pleased to remind you of the services provided by our FDA inspected steriles facility in San Diego, California.

Our NextPharma facility in San Diego (formerly Bioserv Corporation) provides aseptic and non-aseptic bulk formulation, filtration, filling and lyophilization services plus packaging, labelling, validation, documentation services and controlled product storage.  It is FDA inspected for drugs and medical devices and ISO 13485:2003 certified for medical devices.

For further information about how NextPharma can facilitate your business needs please contact Michel Blanc (michel.blanc(at)nextpharma.fr) in Europe or Rich Masino in the United States (rich.masino(at)nextpharma-us.com).