In today’s diagnostic environment, innovations continue at a rapid pace, with emerging molecular diagnostic manufacturers facing increased challenges in meeting complex quality standards, affordability and delivery performance
Canton, Massachusetts. , November 29, 2018 (Newswire.com) - ?AmericanBio Responds to Rapid Growth in Molecular Diagnostic and Liquid Biopsy Markets with New Cutting-edge Manufacturing Facility.
Canton, Massachusetts (November 29, 2018) - In today’s diagnostic environment, innovations continue at a rapid pace, with emerging molecular diagnostic manufacturers facing increased challenges in meeting complex quality standards, affordability and delivery performance. AmericanBio is focused on supporting this niche life science market with expanded manufacturing capabilities designed to meet customers unique manufacturing strategy and product performance requirements. The company’s new facility is now located in Canton, Massachusetts.
American Bio has grown in direct relation to their clients’ unique needs and growth requirements. The capital investment the company has made aligns with industry and client production trends calling for precision-filled reagents along with growing manufacturing batch sizes. Its newly designed, cutting-edge facility offers expanded capabilities with significantly increased ISO class 7 cleanroom space, automated filling and expanded high purity water production capabilities.
“Our customers are driven to bring their valuable ideas to market and so we must consistently invest and expand our infrastructure and operational support to align with their needs and their strategies. Our new facility will help us continue to meet the ever-changing needs and requirements of our life science research and diagnostic customers and also allow us to maintain our competitive edge in the life science market,” says Vin Cooney, AmericanBio’s CEO.
Molecular diagnostic is one of the principal segments of the invitrodiagnostics
“AmericanBio uniquely understood our validation and regulatory needs and has extensive experience in utilizing quality driven metrics to ensure necessary lot-to-lot consistency in the high volume manufacturing of our NeXosome® Isolation Kits,” commented Dr. Robert C. Doss, VP of Product Development at NX Prenatal.
About AmericanBio.
AmericanBio operates in compliance with Current Good Manufacturing Practices (cGMP) and is an ISO 13485 certified provider of biochemicals and contract manufacturing services. NX Prenatal has partnered with AmericanBio to enable the high-volume production of proprietary sample prep kits and reagents to support NX Prenatal’s planned launch of its NeXosome Preterm Birth Risk Assay and related products.
For further information contact:
Contact: Heidi Fleshman
Vice President, Sales and Marketing
508.314.8575
Heidi.Fleshman@AmericanBio.com
