As the biopharmaceutical industry continues to evolve, the demand for safer, more effective biologics—such as monoclonal antibodies, vaccines, and recombinant proteins—is on the rise. With these advances comes a growing emphasis on filtration technologies that can meet stringent purity and performance requirements. Among the various filtration options, polyethersulfone (PES) capsule filters have become a preferred choice for many biologics manufacturing processes.

Why Filtration Matters in Biologics

Biologics are highly sensitive to environmental conditions and contaminants. Unlike small-molecule drugs, these complex molecules can be denatured or rendered inactive by particulates, microbial contaminants, or even leachables from poorly selected filter materials. Filtration, therefore, is not just a processing step—it’s a critical control point for ensuring product safety and efficacy.

The Advantage of PES Membrane Technology

PES (Polyethersulfone) membranes offer several key advantages that make them ideally suited for biologics:

• Low protein binding: PES membranes minimize product loss by reducing non-specific protein adsorption—crucial when filtering expensive biologics.

• High flow rates: The asymmetric structure of PES enables faster filtration without compromising retention efficiency.

• Excellent chemical and thermal compatibility: Suitable for a wide range of buffer systems and sterilization processes.

• High microbial retention: PES membranes are validated for 99.9999% bacterial retention, meeting sterilizing-grade standards (e.g., LRV ≥ 6 for B. diminuta).

Nupore PoreCap® Capsule Filters: Integrity Tested & Validated, Scalable, Sterile

PES capsule filters integrate the PES membrane into a self-contained, disposable unit that simplifies filtration at every scale:

• Single-use convenience: Reduces cleaning validation burden and cross-contamination risk.

• Scalability: Available in a wide range of sizes to support R&D, pilot, and full-scale GMP production.

• Gamma-irradiated or autoclave-compatible: Flexible options depending on sterilization strategy.

• Compact design: Ideal for tight manufacturing spaces and closed system integration.

Common Applications in Biologics

PES capsule filters are widely used across biologics manufacturing workflows:

• Final sterile filtration of monoclonal antibodies (mAbs)

• Cell culture media and buffer filtration

• Clarification of upstream harvest fluids

• Vaccine formulation and fill-finish operations

Why Choose PoreCap® PES Capsule Filters?

At Nupore, our PES capsule filters are engineered to meet the demanding requirements of regulated biologics production. Each unit undergoes rigorous integrity testing and is supported with full validation documentation, including:

• USP Class VI Certified

• Manufactured in accordance with ISO 9001 and ISO 13485 certified quality management systems

• Bacterial challenge testing per ASTM F838-20

• Validated for Extractables and Leachables studies

• Certificate of Quality with each batch

With low extractables, fast flow rates, and proven microbial retention, Nupore PoreCap® PES capsule filters help ensure your biologic product reaches patients with the highest purity and performance.

Looking to streamline your biologics filtration process?
Contact our team to request a free sample or explore our full range of PES capsule filters designed for critical applications.