Signature Biologics, LLC., a biotechnology company, has expanded into a newly constructed 36,000 square foot facility in Irving, Texas.
Signature Biologics manufactures human perinatal-derived products to aid the body’s natural healing process. The company will retain its original facility in the Dallas-Fort Worth metropolitan area as an auxiliary location.
The new facility, which was designed to have an open floor plan, 16,000 square feet of manufacturing laboratory space, six manufacturing ISO-7 cleanrooms, and 16 ISO-5 manufacturing biosafety cabinets. Additionally, it also has 7,500 square feet of research and development laboratory space, three research and development cleanrooms, and six research biosafety cabinets.
Clearly this new facility significantly expands the company’s processing and other operations.
OTW spoke with company Vice President of Sales and Marketing Dan Wagner about the planning process for the new facility. Wagner told OTW, in part, “The expanded Signature Biologics’ location was planned since January of 2020.”
“This new facility,” said Wagner, “helps Signature Biologics to accomplish three main objectives:
- Expand service capacity for existing minimally manipulated tissue products,
- Establish redundant Research & [and] Development locations, and
- Create dedicated cGMP [current good manufacturing practice] manufacturing capacity for 351 biologics in the form of perinatal tissues, commercial cell banks, & and acellular bio-pharmaceuticals which are in the pre-clinical stage or under Approved IND [investigational new drug] study.”
- Wagner also explained that “Signature Biologics’ goals for the remainder of the year are: to serve our clients with our best-in-class allografts and cosmetic products, reach the next milestones in our approved IND study of Signature Cord Prime™ for the treatment symptomatic knee osteoarthritis with our principal investigator, and move from pre-clinical to clinical study phases on two new biologic products (sought indications to be announced soon).”
“By advancing these objectives, we strive to continue to bring safe and effective products to market in the USA and the world to alleviate unmet clinical needs in our communities.”
Presented by RRY Orthopedics.
