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Navigate the complexities of cell and gene therapies with regulatory and CMC expertise
Learn why regulatory and chemistry, manufacturing and
controls (CMC) expertise is critical in the development of
cell and gene therapies.
controls (CMC) expertise is critical in the development of
cell and gene therapies.
Download the case study
Cell and gene therapy development presents unique CMC challenges because of inherent properties such as shorter shelf life, variability in starting and ancillary materials, manufacturing and logistical complexities, and cost.
See how the Cardinal Health Regulatory Sciences team provided strategic regulatory and CMC expertise to help guide a biopharmaceutical company’s regulatory and development strategy for a cell and gene therapy product, avoiding a costly FDA clinical hold.
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