Precigen has officially opened its new manufacturing facility near the company's headquarters in Maryland. Precigen commenced the build-out of the nearly 5,000 sqft manufacturing facility in 2018 to support gene therapy manufacturing. The 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.
The new facility adds to Precigen's existing footprint in Germantown, Maryland, which supports more than 95 employees. To mark the official opening, the company held a ribbon cutting ceremony attended by elected officials and local community members
Dr Schlom is the principal investigator of a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute and Precigen. Under this CRADA, the National Cancer Institute and Precigen are collaborating to evaluate Precigen's proprietary adenoviral vaccines in preclinical and clinical studies for the treatment of cancer.
"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 CDMOs as well as process and timing risks," said Dr Sabzevari, CEO of parent company Intrexon. "This facility puts Precigen in control of our gene therapy manufacturing needs."
The facility includes ISO 7 cleanroom suites that will be utilised 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.
Precigen's multimodal manufacturing strategy increases patient access through shortening manufacturing times using both centralised and decentralised manufacturing processes.
This new state-of-the-art facility supports the company's centralised manufacturing capacity needs for gene therapy vector production, initially centred around viral vectors, used in early-stage clinical trials.
Precigen's decentralised manufacturing will be utilised for UltraCAR-T clinical trials and will occur at clinical centres through its non-viral gene transfer rapid manufacturing process. Rapid manufacturing of UltraCAR-T cells using proprietary non-viral gene transfer process eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to less than two days.
