The growing adoption of single-use (SU) in all process steps of cGMP clinical and commercial production requires enhanced assurance of supply and robust product performance. This innovative bioprocessing bag technology is designed to meet the new challenges of assurance of supply and consistent performance for every process step and application of biomanufacture.
The growing adoption of single-use technologies in all process steps of cGMP clinical and commercial production requires enhanced assurance of quality supply. Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.
The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.
With the uptake of single-use bags in cell culture processes, some manufacturers have reported inconsistent cell growth. Read how Sartorius has addressed the challenge of cell growth performance in single-use bags with their Flexboy® bags and new Flexsafe® platform.
In this article, we’ll discuss four areas that need to be understood to determine the optimum maintenance temperature for advanced therapy material.
In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.
Advances in bioprocess monitoring and analytics, as well as in bioinformatics and computational biology, are changing the way we look at the bioproduction process. This poster explains the drivers of the digital biomanufacturing revolution and how they are steering us towards science-based increased plantwide efficiency, quality, adaptability, and profitability.
Since 2003, after the completion of the Human Genome project, significant progress has been made in sequencing. read how sequencing technologies have revealed astonishing data over the last ten years for multiple species.
Having a sound logistics strategy to ensure that a living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.
If you have asked and answered these five questions, and are using a rigorously designed and qualified shipping system, then the data will provide an objective affirmation that you performed due diligence and significantly advanced the commercial success of your product.
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