Sangamo Therapeutics has secured access to large-scale AAV manufacturing through long-term partner Brammer Bio, a gene therapy CDMO set to be bought by Thermo Fisher.
Sangamo Therapeutics has several gene therapy candidates moving through the clinic, including its own programs for inherited metabolic diseases and partnered programs in hematology with Pfizer and Sanofi.
To support these, the firm has broadened out its manufacturing strategy by securing access to large-scale adeno-associated virus (AAV) manufacturing through an option agreement with contract development and manufacturing organization (CDMO) Brammer Bio.
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“We have been working with Brammer Bio for more than a decade,” Sangamo’s EVP of corporate strategy Stephane Boissel said on a conference call last week.
“The new agreement provides Sangamo with conditional access to dedicated AAV manufacturing bioreactor capacity of up to 2,000 liters, a scale capable of handling commercial grade runs for product candidates such as ST-920, Sangamo’s gene therapy product for Fabry disease.”
Thermo Fisher
The announcement comes weeks after bioprocess services firm Thermo Fisher agreed to acquire Brammer Bio for $1.7 billion (€1.5 billion). The deal is expected to be completed in the next couple of months.
Boissel told investors the acquisition “appears to be good news for Brammer but also for us as we expect that Thermo Fisher Scientific will introduce additional resources and expertise to consolidate Brammer’s capacity and know how” in viral vector manufacturing.
Sangamo’s CEO Sandy Macrae added that his firm is “excited that Thermo Fisher will bring an additional capital for investment along with additional expertise in gene therapy manufacturing,” to Brammer.
Inhouse expansion
Sangamo’s management added the firm will not be solely reliant on outsourcing partners for its gene therapy programs. A Phase I/II GMP manufacturing facility in Brisbane, California is under construction and, according to Boissel, almost complete.
“It is expected to be fully operational in 2020. This facility will provide us with our own capacity to supply our early clinical trials,” he said, and forms part of the firm’s long-term strategy.
“Consolidating control of our industrial, commercial development and manufacturing activity is critical for the development and future commercialization of our GMP finished product. We believe that the combination of in-house manufacturing capacity with long-term strategic relationships with CMOs such as Brammer, will enable us to continue to meet on quality goals and timeline goals while planning for the future success of our therapy.”
Moreover, following the €72 million (US$84 million) acquisition of French biotech TxCell last July, Boissel said Sangamo is considering a plant to build its own GMP unit to manufacture gene modified cellular therapy products. More details will be announced soon, he added.