Developing fluid path consumables for cell therapy applications involves several critical considerations to ensure the integrity, scalability, and sterility of your products. As a leader in the biopharmaceutical manufacturing industry, WHK BioSystems offers extensive experience and tailored solutions to meet these unique challenges.
1. Fluid Path Integrity
The greatest threat to any single-use assembly is leaking. WHK’s extensive experience in the cell and gene (CGT) industry has shown that poor consumable set design can greatly contribute to potential leaks. WHK assesses your design for high-risk connections and common issues such as tube kinking. Post-assessment, WHK creates a customized leak testing protocol to ensure 100% fluid path integrity of every kit built. All verification testing is conducted using in-house leak detection equipment, ensuring precise and thoroughly documented results. Additionally, WHK can incorporate advanced injection molding capabilities to further leak-proof your design. Overmolded junctions can eliminate the use of riskier cable ties, traditional barbed tube fittings, and adhesives. WHK offers various molded configurations and material options, including platinum-cured silicone and thermoplastic elastomers (TPE), with custom designs available.
2. Manufacturing Scalability
As cell and gene therapies progress from research and development to clinical trials and commercial production, scalability becomes a critical factor. Single-use consumables must be designed to accommodate different production scales. Often, a design efficient in small-scale R&D is not compatible with large-scale manufacturing. WHK provides insight and guidance in early project development to avoid this costly problem. They consider aspects like supply chain security of single-use assembly components, labor efficiencies, and packaging. As a fully integrated manufacturer, WHK supports your project from inception to patient delivery.
3. Sterility Assurance
Sterility is paramount in cell and gene therapy to prevent contamination and ensure patient safety. Single-use consumables must be designed with sterility in mind. Overlooking this critical initiative early in the design phase can lead to extended timelines and unforeseen project costs. Gamma irradiation is the most common sterilization method for CGT fluid transfer sets, but device sterility claims require extensive testing and validation to meet ISO 11737 requirements. WHK assists by providing a range of services, from simple advice to full-scale management of your sterility program, considering factors like bioburden, packaging integrity, and raw material vendor management.
By keeping these considerations in mind, you can ensure that your cell therapy fluid path consumables are robust, scalable, and safe. WHK BioSystems is committed to supporting your project at every stage, providing the expertise and capabilities needed to deliver high-quality solutions tailored to your specific needs. Whether you’re at the research phase or scaling up for commercial production, WHK is here to help you achieve success.
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