01.19.12
Pharmaceutics International, Inc. (Pii) began construction of a new 24,000-sq.-ft. cGMP aseptic fill/finish manufacturing facility, expanding the company’s Hunt Valley, MD campus to meet current client projects with near-term commercial manufacturing needs and demand for larger batch sizes.
The new facility will more than double the company's current sterile GMP manufacture capacity. Fill/finish suites will include automated vial and syringe filling, inspection and labeling equipment capable of producing batch sizes of 100,000 plus units.
The facility expansion follows a recent FDA pre-approval inspection (PAI), allowing the company to commercially manufacture an aseptic vial in its existing Hunt Valley aseptic facility.
"Pii has demonstrated its expertise in sterile product development and aseptic manufacturing, offering our clients a quality product with strict adherence to regulatory compliance standards," said Steve King, senior vice president of Pii. "The additional facilities will enable us to support our clients from pre-clinical through commercial-scale production and meet the growing demand for fill/finish services for potent compounds and oncology drugs."
The new facility will more than double the company's current sterile GMP manufacture capacity. Fill/finish suites will include automated vial and syringe filling, inspection and labeling equipment capable of producing batch sizes of 100,000 plus units.
The facility expansion follows a recent FDA pre-approval inspection (PAI), allowing the company to commercially manufacture an aseptic vial in its existing Hunt Valley aseptic facility.
"Pii has demonstrated its expertise in sterile product development and aseptic manufacturing, offering our clients a quality product with strict adherence to regulatory compliance standards," said Steve King, senior vice president of Pii. "The additional facilities will enable us to support our clients from pre-clinical through commercial-scale production and meet the growing demand for fill/finish services for potent compounds and oncology drugs."