Midatech Pharma announces the successful initial scale-up and regulatory inspection of its modern manufacturing site in Bilbao, Spain.
The manufacturing facility produces all Midatech’s gold nanoparticle (GNP) products.
Now, Midatech has installed facilities, equipment and quality assurance systems for in-house manufacturing of its Sustained Release (Q-Sphera) products, at scale.
It added that this new facility had been successfully inspected by the Spanish Agency of Medicines and Medical Devices (AEMPS), and a formal Sustained Release sterile manufacturing licence would be granted upon completion of final process validation which is currently underway.
The first sustained release product to be produced at the Bilbao facility was anticipated to be Q-Octreotide (MTD201), Midatech’s in-development programme for the treatment of acromegaly and carcinoid syndrome.
MTD201 was planned to commence a Phase I study and follow-on regulatory program later in 2017, with anticipated approval and launch expected in 2018/19.
Story provided by StockMarketWire.com