Pii opens development centre and aseptic facility
Pharmaceutics International, Inc (Pii) of baltimore, USA, has opened a 30,000 sq ft development, aseptic filling and cGMP manufacturing facility. The new Beaver Court complex complements the three existing Pii facilities in Hunt Valley, and Pharmaterials in the UK.
Pharmaceutics International, Inc (Pii) of baltimore, USA, has opened a 30,000 sq ft development, aseptic filling and cGMP manufacturing facility. The new Beaver Court complex complements the three existing Pii facilities in Hunt Valley, and Pharmaterials in the UK.
As part of Pii's growth the development work has moved to dedicated manufacturing space in the new building. The area consists of multiple manufacturing and containment suites to handle development projects. This area will support projects prior to moving to cGMP production.
The aseptic facility provides vial filling for clinical supplies and niche commercial manufacturing. Initially the filling line will fill small molecules and is designed to fill containment and high potency products. A 60 sq ft lyophiliser has been installed and qualified to produce lyophilised products.
To complement the existing cGMP manufacturing further capacity has been added to the Beaver Court facility. This expansion includes additional containment rooms for cGMP manufacturing of high potency and containment productions. In addition, commercial size fluid beds in explosion proof rooms have been installed.
Steve King, senior VP of Pii, said: "This expansion is a result of 18 months planning and execution at Pii. It fulfills the market and customer demands for aseptic filling of vials".
Pii is a contract formulation development, clinical trial materials, and manufacturing company based in Hunt Valley, Maryland. It can manufacture most solid, semi-solid dosage and aseptic forms for use in clinical trials and commercial sale. These services are complemented by full analytical and regulatory support.
Acquired in 2008, Pharmaterials Ltd is a technology driven contract research organisation specialising in the optimisation of drug substance physical forms and formulations to facilitate the development of low solubility and poorly permeable drug substances. It is housed in laboratories in Reading, UK and has offices in Tokyo to support an increasing Japanese client base.