Thermo Fisher Scientific says its recently-acquired Brammer Bio is completing $100 million in capital expansion projects, as the viral vector contract development and manufacturing organization (CDMO) looks to satisfy growing demand for gene therapies for clinical and commercial use.

In Alachua, FL, Brammer has added new quality control laboratories, and later this year will bring on an additional process development laboratory and expanded warehouse capacity.

Brammer’s Alachua facility is an 80,000-square-foot early clinical campus consisting of three buildings: a process development and analytical development facility, adjacent to its CGMP Phase I/II clinical manufacturing operation with a third warehouse and office building.

“This expansion allows us to further our 12+ year mission of advancing gene therapy medicines and complements our recent doubling of clinical manufacturing capacity,” Christopher K. Murphy, vice president and general manager of viral vector services in Thermo Fisher Scientific’s Pharma Services Group, and Brammer Bio’s chief operations officer before the acquisition, told GEN.

In Massachusetts, Brammer Bio is expanding one existing facility, and preparing to open a new site. This summer in Cambridge, MA, Brammer will add four drug substance suites and a new drug product suite supporting late-stage and commercial production up to 2,000-L scale, Murphy said. The company is carrying out an 8,000-square-foot renovation of a commercial cGMP facility within a larger 66,000-square-foot building.

And in September, Brammer’s 50,000-square-foot Lexington, MA, commercial facility will come online. The company’s second commercial site will be a new cGMP manufacturing and quality control (QC) operations facility that will include commercial-ready Grade B clean rooms for viral vector manufacturing.

“By year’s end, we will have 27 drug substance suites and four drug product lines active across our network, and our next commercial facility project will be underway,” Murphy added.

Murphy and Paul Jorjorian, head of bioprocess sciences in Thermo Fisher’s Pharma Services Group, spoke about Brammer Bio during the recent Biotechnology Innovation Organization (BIO) 2019 International Convention, held in Philadelphia at the Pennsylvania Convention Center.

Thermo Fisher signaled its intent to expand its presence in gene therapy when it acquired Brammer Bio for approximately $1.7 billion cash, in a deal whose completion was announced on May 1. When the deal was announced in March, Thermo Fisher said Brammer Bio was projected to generate $250 million in revenue this year, and to continue exceeding the market growth rate of 25% over the mid-term.

The combined company, Thermo Fisher says, can better serve gene therapy developers by joining its GMP production expertise and proprietary bioprocessing and cell culture technologies with Brammer Bio’s viral vector capabilities.

“Pretty strong statement”

“Thermo Fisher’s acquisition of Brammer makes a pretty strong statement of where we’re putting a stake in the ground with respect to gene therapy,” Jorjorian said. “We believe that we’re going to be able to, because we’re part of the greater Thermo Fisher organization, and offer a very compelling service offering to our customers.”

Brammer Bio was established as a CDMO in 2016 through a merger of Florida Biologix® and Brammer Bio pharmaceuticals.  At the time of the merger, Florida Biologix had 10 years of providing development, early clinical phase manufacturing, and testing services, supporting biopharmaceutical clients with advanced therapeutic products and processes, including cell and gene therapies.

Thermo Fisher expanded into the CDMO market when it acquired Patheon in 2017 for $7.2 billion. Patheon and Brammer are parts of Thermo Fisher’s pharma services business within its Laboratory Products and Services segment.

“Clearly the value proposition in going to a CDMO for a small and emerging company is relatively straightforward: If you only have a couple of products, going and building your own GMP manufacturing facility is probably not the best business case. You want to take your very, very smart scientific staff, and have them driving on developing new innovative therapies,” Jorjorian said.

“We can come in, develop the process, manufacture the drug, and get it to patients more efficiently than anyone else out there,” he added. “We’re going to continue to deliver a top-tier service for those customers looking to do that.”

Thermo Fisher also signaled growing interest in supporting cell therapy development in February, when it partnered with the immuno-oncology therapy developer Torque to begin build a dedicated Slipstream™ manufacturing facility in Princeton, NJ, for high-efficiency production of Torque’s Deep-Primed™ T cell immunotherapies.

The Slipstream platform uses a fully closed, semi-automated system designed to enable a substantially smaller manufacturing footprint that is less capital- and labor-intensive. The platform will initially be used in the clinical development of Torque’s lead Deep-Primed T cell candidate, TRQ-1501, in solid and hematologic tumors, followed by TRQ-1201, also for solid and hematologic tumors. Thermo Fisher and Torque anticipate processing patient cells by the end of 2019.

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