Pharmaceutics International, Inc (Pii), a US-headquartered contract development and manufacturing organisation specialising in difficult to formulate compounds, will more than double its sterile GMP manufacturing capacity with a new 24,000ft2 cGMP aseptic fill/finish manufacturing plant currently under construction in Hunt Valley, Maryland.
Pii says the expansion is focused on meeting current projects with near-term commercial manufacturing needs and on meeting demand for larger batch sizes
Targeted for completion in the fourth quarter, fill/finish suites will include automated vial and syringe filling, inspection and labelling equipment capable of producing batch sizes of more than 100,000 units.
The facility expansion closely follows the company's recent US FDA pre-approval inspection (PAI) as a result of which Pii has been approved to manufacture commercially an aseptic vial in its existing Hunt Valley aseptic facility.
Steve King, senior vice president of Pii, said the additional facilities would enable the firm to support its clients from pre-clinical to commercial-scale production and meet growing demand for fill/finish services for potent compounds and oncology drugs.