Choosing Safer Single-Use Materials To Enhance Advanced Therapy Manufacturing

By Ian Burdick, MBA, and Jay Collins, Charter Medical, LLC

Historically, single-use technologies used in the manufacture of advanced therapies and other medical innovations have been manufactured with chemicals that have been recently identified as potentially harmful to human and environmental health. Phthalates, a family of chemicals that have commonly been incorporated into plastics and polymer-based materials to increase flexibility and durability, are known to negatively impact human health, and are also slow to naturally biodegrade.

As key players in enabling the design and development of these fragile, potentially life-saving biologic drugs, single-use technology suppliers must align with advanced therapy manufacturers to de-risk single-use manufacturing processes and chemical composition requirements to maintain the safety and efficacy of new treatments. Charter Medical, an innovative single-use solutions developer and supplier for cell therapy manufacturers, continues to prioritize DEHP-free materials selection in the design and development of its standard and custom polymer-based processing solutions such as bags, tubing, transfer sets, overmolds, and manifolds used in cryogenic and cell expansion applications in accordance with global regulatory directives intended to protect the environment and human health.