NextPharma Begins Production At Belgian Facility

Belgium’s regulatory agency, the AFMPS has approved NextPharma Technologies’ new Sterile Product Development Centre (SPDC) in Braine l’Alleud.

NextPharma had signed its first contract in April and will be immediately initiating GMP manufacture for existing customers at the plant.

SPDC is a development-scale manufacturing unit for sterile products, which was inaugurated 12 months ago. It specialises in products for testing in clinical trials. The plant received preliminary approval by AFMPS in July.

The plant will offer formulation, development (including lyophilisation cycle optimisation), methods development and stability testing of sterile products and manufacturing of clinical trials material.

The manufacturing batch size for the plant includes a few hundred vials for early-phase studies, up to more than 100,000 vials for a phase III clinical programme. The plant will also manufacture high-potency active pharmaceutical ingredients (HPAPIs).

The unit will also provide packaging and distribution services, as it has close proximity with a vial-filling unit operated by Aseptic Technologies, NextPharma partner, near Brussels.

Quoted the company as per Pharmafocus, “The new facility is designed to provide customers with a more efficient and faster option to develop and manufacture their products for clinical trials.”