Sangamo Announces Agreement Securing Access To Large-Scale, Commercial-Grade Manufacturing Capacity At Brammer Bio
- Balanced in-house and contract manufacturing strategy to provide clinical and commercial supply for Sangamo's growing pipeline of AAV-based genomic therapies
BRISBANE, Calif., April 2, 2019 /PRNewswire/ -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced it has signed an option agreement with Brammer Bio, a gene therapy contract development and manufacturing organization, to secure access to large-scale AAV manufacturing. Additionally, at Sangamo's new facilities in Brisbane, California, construction is underway of a Phase 1/2 cGMP manufacturing facility, which is expected to be operational in 2020.
"Robust and nimble product development capabilities and access to large-scale manufacturing capacity are strategically important as we expand our plans to develop and commercialize AAV-based gene therapy and genome editing candidates," said Andy Ramelmeier, Sangamo's Chief Manufacturing and Quality Officer. "The facility we are building in Brisbane and our expanded access to commercial-grade supply through Brammer Bio will allow us to continue to meet our quality, cost and timeline goals."
The agreement with Brammer Bio provides Sangamo with access to dedicated AAV manufacturing capacity up to 2000-L bioreactor scale capable of handling large-scale, commercial -grade runs for products such as ST-920, Sangamo's gene therapy product candidate for Fabry disease. The agreement also allows Sangamo to leverage Brammer Bio's viral vector manufacturing know-how in the new Sangamo facility in Brisbane in order to provide a seamless transition from early development to late-stage clinical trials and commercial-scale manufacturing.
"Brammer Bio and Sangamo have worked together for more than a decade, and we are pleased to continue to expand our strong relationship through this agreement," said Mark Bamforth, president and CEO of Brammer Bio. "Once we close the recently announced acquisition of Brammer Bio by Thermo Fisher Scientific, we will be able to leverage their industry-leading scale and capabilities in serving pharma and biotech customers and further support the growth of gene therapy companies such as Sangamo."
About Brammer Bio
Brammer Bio provides clinical and commercial supply of vectors for in vivo gene therapy and ex vivo gene-modified cell therapy, along with process and analytical development, and regulatory support, enabling large pharma and biotech clients to accelerate the delivery of novel medicines to improve patients' health. Brammer is Helping to Cure®. Brammer is owned by Ampersand Capital Partners, the only institutional investor in the company, and its founders.
About Sangamo Therapeutics
Sangamo Therapeutics, Inc. is focused on translating ground-breaking science into genomic medicines with the potential to transform patients' lives using gene therapy, ex vivo gene-edited cell therapy, in vivo genome editing, and gene regulation. For more information about Sangamo, visit www.sangamo.com.
Forward-Looking Statements
This press release contains forward-looking statements based on Sangamo's current expectations. These forward-looking statements include, without limitation, statements related to the anticipated benefits to Sangamo of its option agreement with Brammer Bio, including anticipated access to large-scale AAV manufacturing, the anticipated operational status of Sangamo's planned manufacturing facility and the timing thereof, Sangamo's expectation that its planned manufacturing facility and access to commercial-grade supply through Brammer Bio will allow Sangamo to continue to meet its quality, cost and timeline goals, statements related to Sangamo's potential growth, and other statements that are not historical fact. Actual results may differ materially from these forward-looking statements due to a number of factors, including risks and uncertainties relating to the complex and difficult nature of manufacturing biological components; the ability for Sangamo to successfully collaborate with Brammer Bio; Sangamo's dependence on Brammer Bio for manufacturing support; potential delays in or the inability to complete the build out of Sangamo's planned manufacturing facility; Sangamo's lack of experience as a company in manufacturing biologic products which inexperience could result in adverse regulatory actions or otherwise undermine its ability to utilize its planned manufacturing facility for its own manufacturing needs; whether clinical studies conducted by Sangamo will validate the safety and efficacy of its product candidates; and Sangamo's ability to develop commercially viable products. For a more detailed discussion of these and other risks, please see Sangamo's SEC filings, including the risk factors described in its Annual Report on Form 10-K for the year ended December 31, 2018. Sangamo Therapeutics, Inc. assumes no obligation to update the forward-looking information contained in this press release.
SOURCE Sangamo Therapeutics, Inc.
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