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A vial fill/finish system with an integrated barrier solution has been developed by Flexicon Liquid Filling and Franz Ziel to process emerging personalised medicines and fast track cell, gene and biological therapies.
The emerging role of personalised medicine in advanced therapy medicinal products (ATMPs) and biological therapies has led to a shift in how manufacturers approach batch production methods. Biopharmaceutical companies are increasingly looking for ways to manufacture the smaller batches needed for patient-specific medicines, in a way that is cost-effective to produce and validate.
Enhancing good manufacturing practice (GMP), customer compliance and efficient aseptic manufacturing is also essential as new ATMPs, including cell and gene therapies advance through clinical trials to commercialisation.
Meeting these new requirements, aseptic fill/finish company Flexicon Liquid Filling, part of Watson-Marlow Fluid Technology Solutions (WMFTS), and barrier technology specialists Franz Ziel GmbH have partnered to develop Cellefill, a turnkey, vial fill/finish system with an integrated barrier solution.
Cellefill maximises production efficiency with features including recipe driven, remote set-up, zero waste start-up and no format parts for the entire vial range. Cellefill’s process design includes use of asepticsu single-use-systems and pre-sterilised ready to use product containers that enter the Grade A filling zone by a No Touch Transfer debagging system. Cellefill is a GMP compliant solution that delivers enhanced levels of process flexibility that enables the scale out and quality process repeatability at all levels of manufacturing.
Designed to suit various filling requirements and class cleanrooms, the Cellefill solution is available in three pre-designed and configurable models to reduce project time and fast track therapies to market. Each model delivers enhanced levels of process and quality assurance with highly accurate peristaltic pump performance, integrated barrier and environmental monitoring. Building on the partners’ experience in providing technology and extensive support through validation, qualification and operator training to facilitate a smooth transition into GMP compliant and cost-effective manufacturing, Cellefill supports enhanced levels of product quality and sterility assurance to mitigate risks of contamination.
The challenge for the industry is to produce these new therapies quickly, safely and cost efficiently, with a system that can be rapidly changed over between batch or different small batch medicines. WMFTS says the modularity, flexibility, scale out capabilities and efficiencies establish Cellefill as a next generation vial fill/finish solution for new ATMP and biologic products as they advance through clinical trials to commercialisation.
Tel: 01326 370370