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We offer:
- Analytical development packages supporting the development
or refinement of the manufacture
- Design, testing and validation of cleaning methodologies
- Development, qualification and validation of test methods
- Characterization of proteins, polypeptides and reference
standards
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- Design and execution of comparability studies
- Design, execution and reporting of forced degradation
programs
- Design of stability trials, storage and execution for
drug substance, product and placebo materials
- Production and aliquotting of reference standard material
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