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As recipe parameters and final containers vary considerably from batch to batch, manufacturers are forced to find a way to accommodate faster product changeover while still protecting sterility. We highlight how robotic aseptic fill/finish equipment offers the flexibility to adjust to future growth and the speed-to-market necessary for today’s changing industry.
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Moving forward to the next phases of clinical trials is an extremely exciting and hectic time. Understanding how scaling up affects your aseptic filling operations is essential. Here are four topics to consider that will help ensure that your drug product will be taken care of and be ready for production while increasing your ROI.
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The stringent quality standards surrounding cell and gene therapy point to some necessary differentiators for any successful manufacturing operation. Explore best aseptic practices for cell and gene therapy production that will be foundational to their ongoing development.
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Establishing early and clear tech transfer strategies is a key component of a holistic approach to drug development. When key technologies can seamlessly transfer from system to system, it reduces the need for revalidation and saves valuable time over the life of an operation. Learn about the role that capable fill/finish solutions play in this process.
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The rise of highly targeted cell and gene treatments requiring small batch production at a record pace requires a new path forward for biologics manufacturing. This adjustment has meant a change in orientation for the CMO/CDMO landscape as they work to meet the market demand.
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Small-scale aseptic filling presents a unique set of challenges. Questions regarding how fast a machine needs to run or what material is needed to process can lead to others. Learn about seven factors that you should consider when evaluating small-scale aseptic filling technology that could affect your outcomes.
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Aseptic Filling Systems
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AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill/finish process using single-use pharmaceutical-grade tubing in their peristaltic dosing system to keep shear stress to an absolute minimum.
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Multiformat Filling And Closing Machine
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AST’s GENiSYS® C is an advanced, yet compact, filling and closing system for automated processing of nested, custom, and ready-to-use vials, syringes, and cartridges. With features typically found in large-scale filling machines, this system's compact footprint is ideal for small-scale filling applications.
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