Catalent Pharma Solutions announced today the completion of the construction of its newly renovated 3,300 square foot aseptic fill-finish manufacturing facility at Research Triangle Park (RTP), NC.
Catalent has a comprehensive sterile product formulation and development offering at its RTP site. The product development group conducts preformulation, formulation development, process development and manufacturing support in addition to offering full service analytical development and stability capabilities.
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. These fill finish facilities are designed to comply with global GMP requirements.
This renovation provides four-fold increase of the sterile fill-finish capacity at the Catalent RTP site and adds a new complementary technology to Catalent’s existing service offerings. “It is part of Catalent’s ongoing investment to provide integrated solutions to meet biologic and biosimilar drug development companies’ growing needs,” commented Christine Dolan, Vice President and General Manager of Catalent’s 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.