Belgian authorities positive about NextPharma’s steriles unit
The facility, NextPharma’s sterile products development centre (SPDC), will supply pharma and biopharma industry customers with a broad spectrum of early-stage services, ranging from pre-formulation through to the manufacture of drugs for trials.
Although the AFMPS’ final verdict is not expected until next month, NextPharma's managing director of product development services Sean Marett is confident the new facility will “provide customers with a more efficient and faster option to develop and manufacture their products for clinical trials.”
He added that: “We are able to manufacture batch sizes for early phase clinical development of a few hundred to 6,000 rising to 110,000 vials of cytotoxic product for a Phase III clinical programme.”
The facility is capable of producing high potency OEL4 products, biological injectables, as well as conventional small molecule medication, pharmaceutical emulsions and lyophilised formulations.
NextPharma highlighted the plant’s suite of analytical laboratories which it said will provide customers with molecular testing capacity, lyophilisation cycle development and validation services.
The UK contract manufacturing organisation (CMO) also said that the unit will provide packaging and distribution services for a wide range of products, ranging from small molecule tablets and capsules to hormones and controlled release drugs.
The Belgian plant will work in concert with NextPharma’s worldwide network of manufacturing, storage and distribution centres, all of with comply with the requirements of key global drug regulatory agencies.
Closed-vial filling tech
The location also fits with an agreement NextPharma signed with Aseptic Technologies in September last year.
Under that deal, NextPharma added Aseptic’s “revolutionary” closed vial filling technology, which bypasses traditional washing and stoppering steps using gamma irraditation, to its roster of services.
The vial filling for NextPharma will occur at Aseptic’s facility near Brussels, Belgium. Aseptic believes that it has created a simpler way of complying with increasingly stringent good manufacturing practices (GMP).
