Catalent Increases Sterile Fill-Finish Capacity
Published: July 17th, 2012
Catalent Pharma Solutions has completed construction of its newly-renovated 3300-sq-ft aseptic fill-finish manufacturing facility at Research Triangle Park, NC, where it offers comprehensive sterile product formulation and development.
The renovation provides a four-fold increase of the sterile fill-finish capacity at the site and adds new complementary technology to Catalent’s existing service offerings (see http://www.catalent.com/index.php/development, http://www.catalent.com/index.php/supply). The state-of-the-art sterile clinical manufacturing suite will provide Class A manufacturing space containing a flexible aseptic vial filling line capable of producing Phase I and Phase II clinical trial materials in compliance with global GMP requirements.
The product development group conducts preformulation, formulation development, process development, and manufacturing support in addition to offering full service analytical development and stability capabilities.
“[This renovation] is part of Catalent’s ongoing investment to provide integrated solutions to meet biologic and biosimilar drug development companies’ growing needs,” says Christine Dolan, vice president and general manager, Catalent Development and Analytical Solutions business.
“Combined with Catalent’s GPEx technology, expert biopharmaceutical lab services capabilities, world leading clinical trial supply services, and commercial manufacturing capabilities, we will be able to help our customers bring more products from gene to market.”