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25 Aug 2021

Signature Biologics opens additional manufacturing and R&D facility

Signature Biologics' new 5,000 sq ft research and development laboratory

The new facility will augment the company's capacity to broaden its portfolio of perinatal-derived products

Signature Biologics, a perinatal biologics company, has opened its expanded manufacturing and R&D headquarters in Irving, TX.

The company's increased footprint includes a new 36,000 sq. ft facility which represents the company's expansion in operations across perinatal-derived tissue, acellular products and cellular products to fill unmet clinical needs for patients worldwide.

Signature Biologics has said its prior home in the Dallas-Fort Worth metroplex will remain as a supplementary location and a real-world training site.

The newly constructed facility comprises 16,000 sq. ft laboratory manufacturing space; six manufacturing ISO-7 cleanrooms; 16 ISO-5 manufacturing biosafety cabinets; 7,500 sq. ft of R&D laboratory space; three R&D cleanrooms; and six research biosafety cabinets.

To support the critical cleanroom infrastructure the company has incorporated a robust environmental monitoring system, area segregation with differential pressure, dedicated HVAC systems, and a large power backup generator for critical equipment.

In addition, a master validation plan is in place to guarantee the required performance of the facility, equipment, and consistent results of the manufacturing processes.

With an open floor plan and floor-to-ceiling views into its fully equipped manufacturing and R&D laboratory spaces, the company says it welcomes scientists, practitioners, and medical experts around the world to request a facility tour.

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