Althea opens new GMP production suite
The San Diego-based contract development and manufacturing organization (CDMO) purchased the facility on May 1, 2015. Phased construction and retrofitting have been progressing since January 2016.
As Outsourcing-Pharma.com previously reported, the 57,000 sq ft plant will offer several services. The facility is currently offering process development and analytical services and will be open for GMP bioconjugation and complex formulation in November 2017, according to Althea.
Full manufacturing services, including high containment fill and finish, are expected to begin in Q4 2018.
The first manufacturing contract for the facility has been secured, and while the deal’s terms are confidential, it will include technology transfer, analytical method implementation, process validation, and GMP Drug Product manufacture in preparation for commercial launch of the client's key therapeutic drug, according to Althea.
In August, the CDMO also added a new aseptic fill/finish line at its San Diego headquarters in response to client’s concerns regarding active pharmaceutical ingredient (API) manufacturing costs.