Pharmaceutical company Precigen, Inc., recently opened a new, 5,000-square-foot manufacturing facility in Germantown, Md. Precigent, a wholly-owned subsidiary of Intrexon Corp., is a clinical stage biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients,
The new facility supports gene therapy manufacturing and adds to Precigen's existing footprint in Germantown, Md., which employs more than 95. The "good manufacturing practices" (GMP) facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early stage clinical trial needs.
"Precigen needs to be agile and cost-conscious in our early-stage clinical manufacturing. In today's drug development environment, it's important to reduce a myriad of risks that can impact manufacturing such as technology transfer risks when outsourcing to contract manufacturing organizations as well as process and timing risks," said Helen Sabzevari, President of Precigen,Dr. "This facility puts Precigen in control of our gene therapy manufacturing needs."
Precigen has a Cooperative Research and Development Agreement with the National Center Institute to evaluate Precigen's proprietary adenoviral vaccines in preclinical and clinical studies for the treatment of cancer.
The facility includes ISO 7 cleanroom suites that will be utilized to manufacture gene therapy vectors, such as adenoviral vectors, including AdenoVerse vaccines and AdenoVerse cytokine therapies, as well as cell banks for early-stage gene therapy trials. Due to the flexible design, other types of cell-based biopharmaceutical products can also be manufactured in the facility. Additionally, the facility includes a GMP quality control laboratory that supports lot release and stability testing.
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