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Polysorbate Degradation
Establishing holistic polysorbate control strategies - end-to-end root cause investigation support
Holistic Polysorbate Control Strategies
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Support the setup of a compliant holistic Polysorbate control strategy
Measurement of lipolytic activity of residual enzymes co-purifying with the API
PS method tool box for characterization and quantitative testing
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Polysorbate analytical method development for high protein content products Development and transfer of quantitative quality control methods
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Oxidative degradation or HCP mediated (lipolytic) degradation
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Setup of a compliant VI facility, health authority communication, selection and implementation of AVI, setup of a phase appropriate VI
Related Scientific Bulletins on Polysorbate Control
Visual Inspection Test Sets
Design, manufacturing, qualification and certification of visual inspection test sets
Facility Material Reference Libraries
Building a facility particle library is the foundation for effective particle control and a risk-based approach to quality management.
Particle Control for Cell Therapy Products
Challenges and mitigation strategies for particle control in Cell Therapy products