Using its Supplier Relationship Excellence program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to optimize operational performance.
Three considerations to give you confidence when selecting fluid handling connectors for your bio application.
Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
To drive dependable critical process control requirements, Biogen explored novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.
With their unique separation behaviors and tolerance for relatively high salt concentrations, mixed-mode resins have become important tools in the process developer’s toolbox.
In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and cloud-based tools for data management.
Once you have successfully encapsulated an (API), the next task is to characterize that product and understand its release kinetics, such that it can be labeled and prepared for subsequent studies. Following are some lessons learned from characterizing the end product.
Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”
Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits.
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