Understanding the True Cost of Aseptic Tube Welding in Biopharma: Finding a Better Way

Summary

Historically, biopharmaceutical manufacturers have had to rely on tube welders to unite small-diameter tubes (<3.2mm or <1/8”) in their bioprocesses—simply because no other option existed for closed aseptic processing. As a result, biomanufacturers have traditionally assumed tube-welding associated costs and operational challenges out of necessity. With the recent introduction of the MicroCNX® Series Connectors, biomanufacturers now have a new option of a trusted and user friendly single-use technology. This piece discusses survey data comparing the comprehensive operational costs of tube welding against small volume, sterile, single-use connectors to help bioprocess teams make informed decisions about the best solution for creating their closed aseptic systems.

Download the PDF to read the entire True Cost of Aseptic Tube Welding in Biopharma whitepaper.

Introduction

Biopharmaceutical manufacturers routinely depend on closed aseptic systems to ensure the sterility of the therapeutics they produce. To build closed aseptic bioprocesses, biomanufacturers and process engineers must routinely join individual tubes, forming sterile connections using either single-use connectors or tube welders.

Single-use technologies (SUTs), like single-use sterile connectors, have long played a vital role in the closed processes found in biopharmaceutical product manufacturing. Single-use technologies offer several well-documented benefits for commercial operations, including reduced manufacturing costs, time and labor savings, the elimination of batch cross-contamination risks, and more. Even with single-use connector advantages, biomanufacturers also use sterile tube welding systems for creating a closed aseptic system using smaller diameter tubing (<3.2mm or <1/8”).

As precision medicine gains greater momentum and new candidates enter clinical trials, the demand for smaller batch aseptic manufacturing will grow further. This is especially true for new modalities such as cell and gene therapies and other small-batch biotherapeutics, including those needed for clinical research. However, until recently, small-volume sterile single-use connectors have not been commercially available. This means that sterile tube welding has been the industry’s only solution for building closed aseptic systems with small-diameter tubes. As a result, biologic, cell, and gene therapy manufacturers have assumed the costs and risks associated with tube welders.

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