Gene therapy startup already one of the largest manufacturers in its field … and expanding

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Timothy Miller, CEO of Forge Biologics Inc. Photo: Columbus Business First

COLUMBUS, Ohio (COLUMBUS BUSINESS FIRST) – Although it’s been a little over a year, Forge Biologics Inc. is already one of the top five manufacturers of its kind in the fast-growing gene therapy space.

And an expansion begins next week that will likely propel it to the top.

The Drive Capital-backed startup has gained about a dozen clients, but raising a total of $ 160 million in venture capital has the timeline to build lab space in a 175,000-square-foot facility in Grove City that once housed an automobile , significantly accelerated. Manufacturer and bookstore warehouse.

Four laboratories are in operation and construction of a series of seven laboratories will begin on Monday, which will be followed by seven more depending on market requirements.

“Forge is really at this hockey stick turning point (with rapid growth),” said Co-Founder and CEO Timothy Miller. “We’re probably two to three years ahead of our competitors. It’s not really the money – it’s the people. “

Forge started in July 2020, in the middle of the pandemic, to create a dual model: The company develops gene therapies for rare and often fatal diseases while also serving as a contract manufacturer for other researchers and pharmaceutical companies in the field.

The income from the manufacturing helps to speed up the expensive process of a therapy through regulatory approval.

The company has already grown to 115 employees and is likely to exceed 200 in the coming year, Miller said.

Miller was previously CEO of Abeona Therapeutics Inc., a publicly traded gene therapy spin-off from Nationwide Children’s Hospital.

Co-founder and COO Jaysson Eicholtz had managed gene therapy production at Columbus Hospital. Erandi De Silva, the third co-founder and vice president of product development, had led program management at Myonexus Therapeutics, another children’s spin-off that was acquired in 2019.

The Perceptive Xontogeny Venture Fund led its first $ 40 million round and RA Capital Management led the $ 120 million Series B this spring. Drive Capital LLC, based in Columbus, was involved in both.

Gene therapy uses modified viruses – so-called vectors – to deliver copies of missing or defective genes to the body’s cells. Forge decided to specialize in a specific vector called adeno-associated virus, or AAV, that cannot self-replicate and does not cause known human diseases.

AAV is used in about 8% of all active gene therapy studies, according to the Journal of Genetic Medicine, but a summary of the field this year in the Journal nature called it one of the most promising vectors.

However, growing demand created a production bottleneck – researchers had to wait 18 to 24 months to queue their production.

In the next year, Miller said, Forge will have the largest AAV manufacturing capacity of any contract manufacturer in the world. Shorter waiting times for production could mean life-saving drugs get to market faster.

Forge’s in-house therapy is licensed from the University of Pittsburgh for infantile crab disease, a rare, hereditary condition that almost always kills by age 2 or 3. The therapy is carried out at the same time as a bone marrow transplant.

Children’s spin-off Andelyn Biosciences Inc. is also building a gene therapy facility, but started out on the greenfield on Ohio State University’s west campus. Building in an existing shell helped Forge get up and running faster, Eicholtz said.

Columbus-based BHDP Architecture designed the facility and Skanska, a Swedish company specializing in building the pharmaceutical industry, is the prime contractor.

“I’ve been buzzing around in my head for a decade, I wanted to build something like this,” said Eicholtz.

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