How to Identify Optimal Materials for Biopharma Single-Use Solutions

Material choices for biopharma single-use systems directly impact process integrity, product purity, and operational efficiency in advanced therapy manufacturing. Correctly selected materials for bags, tubing, transfer sets, and manifolds support metabolism, gas exchange, and sterility throughout the process.

Cell Culture

Choose bioinert and gas-permeable materials, such as breathable polyolefin, to optimize metabolism and cell viability.

Transfer

Utilize durable yet flexible bag materials that provide essential gas transmission during fluid transfer, and employ DEHP-free polyvinyl chloride (PVC), silicone, or thermoplastic elastomer tubing to minimize cell shear and maintain fluid dynamics during aseptic transfers.

Formulation

Select low-extractable polyolefin materials to preserve purity during mixing and connectivity for large-volume or batch processing, and assess interactions with formulation additives such as dimethyl sulfoxide (DMSO).

Storage

For long-term storage, layered polyethylene films offer durability, impermeability, and a gas barrier. For high-volume applications, multi-layer materials can combine strength and flexibility.

Filtration

Consider polymer-based textile components made of polyester or nylon to optimize filtration performance and durability under pressure or degradation conditions.

Waste Disposal

Capture process waste using materials such as polyethylene and polyvinyl chloride that balance durability and cost while accommodating fluctuating temperatures and pH levels.

Cryopreservation

Use flexible, durable polymers such as thermoplastic elastomers and low-temperature polyolefin to prevent cold cracking and safeguard the end product for therapy administration.

Charter Medical offers standard and custom single-use solutions for biopharma manufacturing, designed to align material selection with process requirements and regulatory expectations.