Capabilities

Research and Development

 

PharmaForce is an industry leader in rapid, high quality sterile drug product development. Our Research & Development team is capable of performing a wide range of drug development activities, including formulation development, analytical method development & validation, lyophilization cycle development, process scale-up, technology transfer, stability data generation and NDA/ ANDA document preparation for FDA submission.

The R&D group is capable of developing a multitude of dosage forms namely, liquid and lyophilized injectables, ophthalmic and otic products, Novel Drug Delivery Systems (NDDS) and injectable suspensions.

Our development cycles include risk assessment of pipeline candidates followed by product development, manufacturing, stability generation, regulatory submissions, product launch activities and post-approval support.






Manufacturing

PharmaForce manufactures sterile finished dosage pharmaceutical products in its traditional fill-finish facility located in Hilliard, Ohio, a suburb of Columbus. The facility was commissioned in November 2005. The newest addition to PharmaForce’s facilities as of 2011 is located in New Albany, Ohio. It consists of a state of the art, 109,000 sq. ft. facility which includes 15,000 sq. ft of Research and Development laboratories, 13,000 sq. ft administration area, and a 72,000 sq. ft. Manufacturing Area that is capable of manufacturing highly potent compounds and cytotoxic products. The aseptic filling is managed by two state-of-the-art Bosch Isolator systems that are connected to two production-scale lyophilizers. Additionally, the manufacturing area is equipped with two fully automated, high speed inspection and packaging lines.

The plants provide manufacturing support for the commercialization of sterile pharmaceutical products targeted for U.S. markets. The facilities enable PharmaForce to ensure an uninterrupted source of commercial supply while also providing advanced development and clinical manufacturing opportunities. All batches are manufactured in accordance with current Good Manufacturing Practices (cGMPs).

Clinical manufacturing activities can support Pre-IND and IND Phase I-III activities. All clinical batches use the same documentation, equipment, and personnel as our commercial production batches. 


Each of our facilities offers unique sterile manufacturing capabilities. We offer a broad range of batch sizes with fill volumes from 0.5 mL to 50 mL in vial sizes from 2 mL to 50 mL. Product can be packaged in glass (vials, ampules, and bottles) and plastic (vials and bottles).



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