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Considerations for Design of Novel Therapeutic Manufacturing Facilities

Friday 02 November 2018

At the upcoming 2018 ISPE Annual Meeting & Expo in Philadelphia, DPS Group’s Indu Conley and client Katie Shannon of Brammer Bio, will present on the topic, “Considerations for Design of Novel Therapeutic Manufacturing Facilities.” The presentation will discuss the design of manufacturing facilities for the production of novel therapeutics and how such facilities require careful planning and consideration of a myriad of factors. Those factors include throughput, biosafety levels, product segregation and contamination control, regulatory environment, time to market and tech transfer challenges. It is a complex mix of elements that requires a project team to move quickly and effectively to de-risk the investment and meet market demand.

Brammer Bio has embarked on an ambitious program in Massachusetts to bring online multiple production facilities and associated support areas for viral vector manufacturing, including fill/finish capabilities, to meet current and project client demand. Brammer’s focus in the CDMO space adds particular complexity to planning and designing facilities that are eminently flexible in anticipation of potential client requests for their gene therapy program, which cover a broad spectrum of viral vector platforms with enabling technologies ranging from benchtop to 2,000L scale.

This presentation will be held on November 05, 2018 at the 2018 ISPE Annual Meeting & Expo in Philadelphia, and will highlight Brammer’s approach, in partnership with the DPS Group, for the planning, design, and construction of their facilities, and well as general considerations for the success of novel therapeutic manufacturing facility design projects in a continuously evolving and dynamic marketplace.

About the presenters

Indu Conley is the lead process engineer and process department manager at DPS Group where she has led the department since it opened its first U.S. office in Framingham, Mass. in 2011. She has more than 18 years of experience in the biopharmaceutical industry with significant experience in large-scale mammalian cell culture processes.

 

Katie Shannon, senior director of global engineering at Brammer Bio, has more than 16 years of biopharmaceutical engineering experience in roles spanning new facility construction through commercial manufacturing support. In her role at Brammer Bio, she is responsible for capital portfolio management and project execution, global engineering/CQV standards and best practices, asset management, real estate, and site services.

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