Nextpharma gets nod for Belgian manufacturing unit
pharmafile | July 24, 2009 | News story | Manufacturing and Production | Next Pharma
UK contract development and manufacturing company NextPharma has won a preliminary green light from the authorities in Belgium for its recently opened sterile facility in Braine-l'Alleud.
The so-called Sterile Product Development Centre (SPDC) is a development-scale manufacturing unit for sterile products, specialising in supplying volumes of product for testing in clinical trials. The inspection by the Belgian Medicines Agency (AFMPS) was 'positive', said the company, and should lead to official approval in a few weeks.
The Braine-l'Alleud facility is an important development for NextPharma as for the first time it allows the company to start offering development and manufacturing services for monoclonal antibodies, proteins, peptides, RNA interference agents 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 new facility is designed to provide customers with a more efficient and faster option to develop and manufacture their products for clinical trials, commented Sean Marett, NextPharma's managing director.
The SPDC offers formulation, development (including lyophilisation cycle optimisation), methods development and stability testing of sterile products and manufacturing of clinical trials material. It will also provide packaging and distribution services.
It is able to manufacture batch sizes from just a few hundred vials for early-phase studies, up to more than 100,000 vials for a phase III clinical programme, and can also be used to make high-potency active pharmaceutical ingredients (HPAPIs) such as cytotoxics, thanks to a segregated and contained production line.
The unit opened in October last year, and in April NextPharma announced its first contract at the new facility. Under the terms of that deal, the UK contract manufacturer has agreed to formulate, freeze dry and manufacture pilot and Good Manufacturing Practice (GMP) standard batches of a sterile peptide-based drug product for an undisclosed customer.
NextPharma now operates seven product development centres around the world, along with seven manufacturing plants and six temperature-controlled storage and distribution centres.
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