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Webinar

Sterility, Manufacturing and Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals

0 h 53 min

The biopharmaceutical sector is experiencing rapid changes, transitioning from monoclonal antibodies to advanced therapies such as Cell and Gene Therapy and RNA-based Therapeutics. This evolution is driven by the growing healthcare needs that demand cost-effective and rapid manufacturing technologies. The approval of biosimilars and the adoption of continuous manufacturing techniques have enabled manufacturers to meet these increasing demands.

One of the most significant shifts in the industry is the move from fixed stainless steel systems to Single Use Systems (SUS). This transformation has revolutionized the therapeutic market. SUS, primarily composed of plastic components that are sealed and sterilized using irradiation, have seen rapid market growth, a trend that is expected to continue.

This webinar will focus on various aspects of product development within the context of SUS. It will cover sterilization and lab testing strategies that are essential to ensure the absence of contamination during the development and manufacturing processes. Attendees will gain insights into how these strategies promote end-user safety, a critical concern in the production of biopharmaceuticals.

The presentation will delve into the specifics of SUS, exploring their advantages over traditional fixed systems, and discussing the methods used to ensure their sterility and integrity. The shift to SUS has not only improved efficiency but also enhanced the flexibility of manufacturing processes, enabling quicker turnaround times and reducing costs.

Participants will learn about the latest developments in sterilization techniques and lab testing protocols that help maintain the safety and efficacy of SUS. The webinar will highlight best practices and innovative approaches to managing the challenges associated with the use of plastic components in biopharmaceutical manufacturing.

This webinar is crucial for professionals involved in biopharmaceutical manufacturing, product development, and quality assurance. By attending, you will be equipped with the knowledge and tools to implement effective sterilization and testing strategies, ensuring the production of safe and reliable biopharmaceutical products.

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