Manufacturing Expansion Planned to Meet Growing Demand
By Terry Troy
Forge Biologics, a gene therapy-focused contract development and manufacturing organization, is planning an expansion this year to meet the growing demand for its gene therapy manufacturing. The expansion will coincide with an accelerated increase in headcount and expansion of The Hearth facility in Columbus, both aided by continued investments in the company.
Forge has entered into a secured financing agreement with MidCap Financial that provides up to $80 million of borrowing capacity. This non-dilutive financing will support the facility expansion and new client offerings to be announced in 2022.
“We are excited to deliver on our goal of offering our clients expanded manufacturing capacity, while providing access to some of the largest suspension bioreactors available in the industry,” said Timothy J. Miller, Ph.D., Chief Executive Officer, president, and co-Founder of Forge. “This increased scale, combined with our automated fill-finish capabilities, positions Forge as an ideal partner for clients moving beyond the clinic to commercial launch and supply, particularly those needing to manufacture cGMP AAV.”
The Hearth is a custom-designed cGMP facility dedicated to AAV vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. (cGMP is a common regulator of ion channel conductance, glycogenolysis, and cellular apoptosis, while Adeno-associated virus (AAV) is one of the most actively investigated gene therapy vehicles.)
The larger scale bioreactor capacity available for clients will be supported by continued growth in staffing as the company grows towards 400 employees, which will now be accelerated by a grant received from the State of Ohio to support new hires over the next three years.
“Forge Biologics is a pioneering company established and rapidly growing right here in Ohio,” said J.P. Nauseef, president and CEO of JobsOhio. “The world-class researchers, talent and investors in Ohio have created an environment where Forge can develop life-changing gene therapy advancements that can positively impact lives worldwide.”
Forge initiated the facility expansion in 2021 and is increasing the overall manufacturing footprint of the company to over 200,000 square feet of facility space, including 20 cGMP manufacturing suites, with the ability to add more suites in the current facility in the future.
The ongoing facility expansion significantly increases the number and capacity of Forge’s bioreactors, including installation of 5,000L cGMP bioreactors for large-scale client needs in clinical and commercial programs for use with Forge’s proprietary suspension HEK 293 IgnitionTM cell line. The expansion also adds automated cGMP fill-finish capabilities to Forge’s offerings, designed with a cleanroom background classification that meets European Medicines Agency requirements for late-stage clinical and commercial filling needs. Both the 5,000L bioreactors and automated filling systems are expected to be available for client use in the second half of 2022.
The additional funding brings Forge’s total financing to approximately $240 million. Forge previously secured $160 million in two prior rounds with the closing of a $40 million Series A financing in July 2020, and a $120 million Series B round in April of 2021.